Transcripts For CSPAN2 FDA 20240703

The committee on oversight and accountability will come to order. I want to welcome everyone here today. Without objection the chair may declare a recess at any time. I will recognize myself for an opening statement. I want to again welcome to the committee on oversight. We want to thank the commissioner for his participation in todays hearing of the u. S. Food and Drug Administration. There might not be a federal agency thats more integral to americans lives than the fda. Fda is charged with Regulatory Oversight of the food and drug industries. Industries that ensure americans have food on the table by innovating safer and more stable crops. Industries that provide americans new medications to treat diseases. Industries that create cuttingedge medical devices that can keep your heart pumping or replace your knee. These industries are vital to keep americans safe, healthy, and happy. These industries provide millions of jobs and nearly 3 trillion in economic value. Congress must ensure the fda is prioritizing safe and effective but also incentivizing innovation. Unfortunately the fda under President Biden suffering from dysfunction, failing to do the bare minimum to carry out the core mission, which is to make certain our nations food and drug products are safe and effective. Subcommittee chairwoman mcclain launched an investigation into the infant formula crisis. Her subcommittee revealed how the fda attempted to hide behind the covid19 pandemic as an excuse for neglecting facility inspections and justifying poor performance. The fdas work policies and lax approach to oversight were unprepared to address the short and issues. Additionally, the Biden White House on the fda took three months to act to increase production of infant formula. The result of these failures, barren shelves, leaving millions of young families unable to access the formula needed to feed their babies. Weve also investigated the f. D. A. s failure to prepare for and adequately respond to drug shortages for essential medications used to treat Heart Disease and cancer just to name a few samples. F. D. A. And democratic policies like the Inflation Reduction Act have dramaticly diminished the profitability of manufacturing generic medications. This has resulted in fewer manufacturers and a greater risk of shortage. The f. D. A. Must improve coordination with manufacturers and federal agencies, including the dea, doj, and dod to increase production. The f. D. A. s failed to incentivize domestic manufacturing of pharmaceuticals, resulting in significant offshoring of these facilities. We conducted oversight of the f. D. A. s failure to return to prepandemic levels of inspections of those manufacturing facilities for Prescription Drugs abroad. Inspections of foreign manufacturing facilities were 79 lower in 2022 than 2019. Last year alone this failure resulted in two separate recalls of eye drops, manufactured in india, that caused an outbreak of dangerous drugresistant bacteria, killing four people. Through our investigation of Tobacco Products regulations, we learned the fda is failing to consistently and effectively regulate Tobacco Products. According to the Reagan Udall Foundation, the fda has been reactive and overwhelmed in its Tobacco Products regulation. The f. D. A. Has delayed review of applications for products that can retkaus hrarpl for Many Americans reduce harm for Many Americans. Further, their failure to regulate has allowed unsafe and illicit products to proliferate. In fact, the United States court of appeals for the fifth circuit slammed the fda for sending manufacturers a flavored ecigarette products on a wild goose chase. Meanwhile, the fda is also failing to prevent illicit flavored Tobacco Products from china entering the country and harming americans. The f. D. A. s not implementing Enforcement Actions to address illicit flavored Tobacco Products in Stores Across the country. Additionally, the committee examined the f. D. A. s refusal to regulate attempt hemp derived products like cbd. Instead of using its existing authority, the fda is requesting new authorities and money that it does not need. This is the f. D. A. Putting its own bureaucratic priorities over the American People who can benefit from these products. The f. D. A. s refusal to regulate hemp products is creating a significant confusion in the market and resulting in products with intoxicants that can be dangerous to americans who use these products. It has also halted business trying in good faith to enter the market while bad actors continue to thrive. Finally, we found that the fda ignored decades of research regarding the ineffectiveness of an overthecounter decongestant causing americans to waste their , hardearned money on a medication thats ineeffective. These examples are just scratching the surface of the dysfunction and failures that are ongoing within the f. D. A. Today im hopeful we can take a deep dive to understand how the f. D. A. Is responding and taking action to ensure a safe food and drug supply. I now yield to ranking nebraska raskin for his opening statement. Ranking member raskin for his opening statement. Mr. Raskin thank you very much, mr. Chairman. And thank you to commissioner for being with us here today. The fda regulates everything from bottled water to infant formula, meat and poutry and egg products, prediction and nonprediction drugs, vaccines, medical devices, microwaves, personal Care Products and tobacco. During the bidenharris administration, the f. D. A. s made critical progress to ensure that we have access to safer food and to effective drugs. For example, last fall f. D. A. Acted quickly to investigate reports of lead appearing in childrens cinnamon apple sauce pacts for their school lunch. The cinnamon was adultered with lead which was added by the manufacturer in order to increase the weight of the product to make it more profitable in the process. However, the apple sauce contamination issue could have been completely prevented if end product inspections for food were required. The fda asked congress to amend the food, drug and cosmetic act as part of the f. Y. 2024 budget request to require that industry conduct testing of final products exactly for such contaminants and provide f. D. A. Immediate access to those results. This would greatly help to ensure the safety of all of our Food Products for kids and for everyone else. But the f. D. A. Needs these additional authorities to make that happen. And, mr. Chairman, i was very pleased to hear your opening comments and i hope you would join me in supporting giving the fda additional Regulatory Authority precisely to address the kinds of problems that both you and i have identified. The fda itself has proposed multiple solutions that would address the problems were talking about today. The democrats support greater and more refined Regulatory Authority to make our food and drugs safer and we hope our colleagues will join us. In the wake of infant formula and Prescription Drug shortage, fda also advanced leg legislative proposals earlier this year to strength notification requirements in data sharing. Right now they dont have any authority to tell drug manufacturers to produce more drugs. One proposal theyve offered would require manufacturers to notify the fda, dealing with this first problem of the applesauce, would require manufacturers to notify fda about pathogens that are discovered in certain critical foods. In the case of infant formula, this would prevent contaminated infant formula from reaching any more consumers and babies. A second proposal would expand fdas authority to gather data from industry about potential drug shorting ans and supply chain disruptions shortages and supply chain disruptions. The fda advanced the accessibility of medication abortion by removing the inperson dispensing requirement for a drug and allowing it to be distributed by mail through retail pharmacies. In july, 2023, fda approved the first overthecounter Birth Control pill. As a result, consumers access to contraception has improved at a crit tal time when many critical time when many states are enacting increasingly draconian and oppressive abortion restrictions. Fda also made advancements to combat a range of lifethreatening diseases. Fda approved the first opioid overdose medication a step , toward reversing opioid Overdose Deaths in our district. They also approved a new gene home Editing Technology to treat sickle cell anemia, a disease that has ravaged a lot of communities, primarily africanamericans. This advancement is a crucial step towards treating sickle cell anemia and represents a break through in gene therapy. Fda also secured additional supply chains in the wake of cancer drug shortages. Its crucial that fda continue to carry out its mission and create meaningful regulations based on sound science and not conspiracy theories or ideological programs. Public attacks on fda without any corresponding legislative solutions simply undermine its ability to effectively protect Public Health. Antiabortion activists brought a case against fda over its updated guidance on the first of a twopill medication abortion. The activists claimed that fda did not properly collect data on drug risks and complications. However, this claim is contrary to the fdas review of, quote, Extensive Research showing that it is safe, including to take it home, unquote. Fda followed its standard procedure in reaching that conclusion and according to the fda, it must act reasonably based on the information available, rather than act based on perfect data which seldom exists. If the objective of antiabortion activists is to undermine fdas authority, the consequences will be devastating to Public Health and fda that bases its decisions on Political Science rather than actual science is not in the best interest of consumers. Congress must ensure the fdas empowered to rely on the facts rather than bend to the will of people pushing an ideological agenda. Thank you, mr. Chairman, and i yield back. Mr. Comer the gentleman yields back. The witness will please stand and raise his right hand. Do you solemnly swear or affirm that the testimony youre about to give is the truth, the whole truth and nothing but the truth, so help you god . Let the record show the witness answered in the affirmative. We appreciate you being here today and look forward to your testimony. Let me remind the witness, im pretty sure youre an old pro at this by now, weve read your written statement, it will appear in full in the hearing record. Please limit your oral statements to five minutes. As a reminder, press the button on the microphone in front of you so that its on and that members can hear you. When you begin to speak the light in front of you will turn green. After four minutes the light will turn yellow. When the red light turns on, your five minutes is expired. We would ask that you would please wrap up. I now recognize commissioner callif to please begin his opening statements. Thank you, chair comer, Ranking Member raskin, and members of the committee. Thanks for the opportunity to testify about the food and Drug Administrations work to protect and promote Public Health. In the United States the safety of food and medical products depend on industry and the fda industry bears the responsibility of creating a supply of medical, food and cosmetic products that are safe and protect and promote Public Health. From that lens, id like to focus on the agencys work in four main areas today. First, addressing vulnerabilities in the supply chain. Second, reversing the decline in our National Life expectancy. Third, accelerating effective treatment for thousands of rare genetic diseases, and, fourth, undertaking the most significant reorganization in fda history with a focus on human foods and improving oversight of all of our regulated industries. As we saw during the pandemic and continue to see, we have a significant Global Supply chain vulnerability, including lack of redundancy and resiliency, and overreliance on foreign sources for critical products, particularly medicines and devices. Preventing and mitigating supply chain issues in the industries we regulate have been a primary focus. In 2023 alone we worked with manufacturers to prevent over 230 threatened drug shortages. During the infant formula shortage, fdas use of temporary Enforcement Discretion enabled Safe Products to enter the u. S. Market, which increased supply and doubled the number of firms producing infant formula for the u. S. From 2021 to 2022. Fdas continued oversight will be critical until supply chains are more resilient, particularly for infant formula. Well continue to promote competition and manufacturing quality and implement modernized systems to respond to shortages faster. Its why we requested additional authorities that would provide more visibility into the supply chain. The trends in Life Expectancy and chronic disease in the u. S. Are concerning. And while we are leading the world in the creation of new drugs and devices, our major cause of death and disability are driven by fundamentals. Tobacco use, poor nutrition and lack of adherence to inexpensive, generic medications. Given the burden of tobaccorelated diseases, its encouraging that over the past year weve seen a reduction in cigarette smoking in the u. S. And a significant decrease in overall tobacco product use among High School Students. Primarily driven by a decline in ecigarette use. Despite these important wins, by a combination of education and Enforcement Actions, our work is not finished. We remain committed to reducing the Health Burden of tobacco product use in the u. S. Food safety and improved nutrition are essential to combat the epidemic of chronic disease and premature death. The healthier food supply coupled with improvements in key Nutrition Information will help consumers make informed health choices. This includes proposed actions to simplify at a glance the packaged Nutrition Information to establish sodium targets, update the definition of the term healthy in advertising, and create a Nutrition Center of excellence. Thanks to Congress Investment in the human genome project decades ago, many of the approximately 10,000 Rare Diseases which impact at least 30 million americans can now be treated with gene therapy technologies. Were preparing to navigate a large number of these exciting therapies that will require new Clinical Trial methods, deep scientific review or expertise and development of reliable longterm followup systems involving Electronic Health records for realworld evidence. Lastly, the agency has made significant progress in its proposed reorganization. The proposal aims to unify human food functions into the new Human Foods Program under the direction of the Deputy Commissioner for human foods and to solidify the office of Regulatory Affairs role as a front line of fdas fieldbased operations. This will enhance our outbreak response and fully realize the preventive vision of the federal Drug Administration act. These proposed changes will strengthen the agency making it more efficient and nimble and ready for the future with the everchanging and complex industries we regulate. In conclusion, the essential work of the agency continues in thousands of work streams that americans and the world count on every day. Thanks to the dedication and perseverance of fda staff. We look forward to continuing to work with congress on the agencys mission and thank you for the opportunity to testify. Mr. Comer thank you very much, commissioner. Well now begin the questioning phase. Chair recognizes representative gosar from arizona for five minutes. Mr. Gosar i thank the chairman. Now obviously the fda made a mistake in granting the emergency use authorization and license of covid19 vaccines. It has been confirmed that the vaccines do not stop transmission. Moreover, 1,635,048 injuries due to the covid19 vaccine have been reported, including 37,382 deaths. Considering that under 10,300 deaths have been reported due to all other vaccines combined, the harm due to the covid19 vaccines is staggering. Not to mention there is no accountability. Legally it is impossible to sue covid19 vaccine manufacturers for the injuries caused by their products. Just last month the federal court forced the fda to retract tweets and statements for its years long Smear Campaign against ivermectin as an effective treatment for covid19. Now lets talk about ozempic. Jpmorgan predicts that it and similar drugs will exceed 100 billion by 2030. Concerningly, theres a plethora of federal lawsuits, 18 in all so far, alleging serious side effects from this class of drugs. Stomach paralysis and several severe indigestion, vomiting and obstruction have been cited in the lawsuits. One woman claimed to have lost teeth from excessive and frequent vomiting. One law firm is investigating the claims of additional 10,000 people potentially harmed by this class of drugs. The plaintiffs predict 20,000 total people will be suing manufacturers of the glp1ras in the future. The European Medicine Agency is investigating was epic oze mpic for suicidal ideation, according to forbes. Also according to forbes, studies indicate ozempic and others like it may cause gal bladder disease, furthermore, a recent study linked ozempic to thyroid cancer. Its basically a synthetic hormone that tells your brain it is full, therefore deactivating digestion. As well as causing the pancreas to increase insulin levels in order to lower blood sugar. Does purposely paralyzing the stomach strike you as a healing type of remedy . It doesnt to me. It seems that the goal of big pharma is to get people hooked on it for life on their products. Whether it be an annual flu or covid19 vaccine, perpetual statins to lower cholesterol beta blockers for high brood , pressure, expensive, neverending cancer treatments. Yet it never seems to yield much fruit. Chronic disease is skyrocketing. 50 of americans have chronic disease. For 40 of americans have two or more. Are ozempic and related drugs the next big things big pharma is going to push on millions of people no matter the harms . The head of the fda, should like to take this opportunity to express your regret as head of the fda, would you like to take an opportunity to express your regret in failing to curtail the chronic disease epidemic in america . Mr. Califf i would like to respond. You raised so many issues and ive got a minute and 20 seconds. So ill just start with the vaccine. Which i think may be the most important one to talk about. So heres the progression as i see it. First of all, im pretty simple. Im from South Carolina. And im a cardiologist. Im used to looking at life and death and seeing what the differences are. The question with any medical intervention, knowing that all interventions have risks and benefits, and the question is always, do the benefits outweigh the risk . The initial vaccine trial that led to the e. U. A. Did show a dramatic reduction in the rate of infection in the two groups. The virus then mutated but the good news is now we have a progression of overwhelming evidence in every country, including the United States, [talking simultaneously] mr. Gosar i understand. Mr. Califf youre less likely to be dead or admitted into the intensive care unit. If you live in a county with a higher vaccine rate, the mortality rate is lower. If you live in a country with a higher vaccine rate, the mortality rate is lower. So when you compare the two, yes, vaccines have side effects. The risk of being dead is lower if youre vaccinated. Mr. Gosar ok, wouldnt you agree, this is my last question because im running out of time, dont you agree that the vaccine should have put into the fund or face liability issues . Because the people were used as guinea pigs. Do you believe in Peer Reviewed science . Because theres another part that didnt get really reviewed very well. Mr. Califf ill remind you again, we always have to do studies or Clinical Trials to figure out the risks and the benefits. Thats a normal part in most of my career. I personally participated in Clinical Trials when i have the chance. So that we can have the data and the knowledge to make wise decisions and get vaccinated so were less likely to be dead. Mr. Gosar i get that but why do you have to retract everything you said about ivermectin . Because your office came out against it. I agree that theres some problems in the manufacturing of that dosage. But if in doubt, leave it out. Mr. Califf we didnt retract everything we had to say about it. And in fact, we had an attack against ivermectin. Mr. Gosar they ordered you to. Mr. Califf if you look at the randomized trials of ivermectin, and there are many of them now, there is no benefit of ivermectin in the treatment of covid. Thats a fact. Any drug for which theres no benefit in their risk, people have to make their own decisions about what to do. What were plot doing is telling doctors what they have to do. Doctors have the right to prescribe off label. Your time has expired. The chair recognizes the Ranking Member for five minutes. Mr. Raskin thank you. Im going to follow up on this because this exchange to me was extremely illuminating because what we have here is the commissioner as the head of the federal Drug Administration and then we get a driveby spray of propaganda, disinformation and ideological attacks. So let me try to sort some of this out and maybe well help to illuminate why we have a food and Drug Administration, rather than leave it to politicians to make decisions based on ideological whim. Lets start with ivermectin, which i believe is an animal deworming agent that some people were advocating for use to treat covid19. Has this been approved as a form of treatment or a cure for covid19 . Mr. Califf no, it has not. If i may, i should also point out, it also has benefit for humans with worms which is a huge problem in asia. So it actually won a nobel prize because its an amazing drug both for animals and humans who have worms and theres good reason to think it may work in the case of covid and thats why thankfully the community, including the n. I. H. , did a number of randomized Clinical Trials. Theres just no benefit. Thats true of most things that we try. Theres nothing wrong with thinking it might work, it just didnt. Mr. Raskin what about another what about hydroxychloroquine, another one that was advocated . Mr. Califf basically the same story. There was really exciting preliminary work in the laboratory that said it may have activity against covid so the randomized trials were done. Unfortunately no benefit. Again, nothing wrong with thinking it may work and trying it out in a randomized trial. But then we have the data now so that leads you to the conclusion. So we have not been able to grant medication for those. Mr. Raskin im aware of a lot of political attacks and criticism against fda but i can never figure out the coherence of it. Sometimes they seem to be saying, get out of the way and just let anybody advocate whatever they want and use whatever they want without any testing and without the various protocols you go through. And then other times they attack you because you dont have enough authority to do the things that we would want you to do in order to make kids cinnamon applesauce clean, for example. So lets take that one which has caught my eye, since we certainly ate a lot of cinnamon applesauce in our house when our kids were little. Lets see. The fda regulated products are manufactured or handled at Something Like 275,000 or 280,000 different registered facilities across the land. So what keeps you from inspecting every private manufacturing facility that produces things like cinnamon applesauce or Peanut Butter . Mr. Califf if i may, ill try to do this very quickly. I think the best way to think about fda in general is were referees. You all in Congress Actually write the rulebook, much like in any sport. Its the leadership that writes the rulebook. We enact whats in the rulebook. And in the case of food establishments, like most sports, the first line of defense are the players in the game. Which are the is the industry that produces the products. And by and large they do a great job. But sometimes they dont. And as referees we have to be really wise about where we step in because we dont have an unlimited budget. So what keeps us from inspecting all 275,000 . You dont have to be a brain brilliant mathematician to know how many people youd have to have, but what we can do, for example, in food for children is to have the manufacturers be required to do the testing. Which is the way the drug system works. The manufacturers of drugs have to test every batch and in the case of cinnamon applesauce, if there had been mandatory testing, when it got imported into the u. S. From ecuador, the stores that were selling it probably would have picked it up at that point. Mr. Raskin those kids ended up with lead poisoning, right . Mr. Califf yes, its a very serious problem and it causes chronic issues. Mr. Raskin so you advocated mandatory testing . You would like us to give you that Regulatory Authority . Mr. Califf yes. Mr. Raskin and i hope i do hope that something that our colleagues on the republican side of the aisle would join us in, in the case of infant formula shortages, last congress we passed a bipartisan bill to help address those shortages, but nearly 200 House Republicans voted against a second bill to give fda resources to strengthen its oversight and inspection of facilities to prevent shortages like that from happening. We cant have it both ways. If we want an effective, strong regulator, we have to give them the authority and the resources to get the job done. Thank you very much, mr. Chairman. I yield back. Mr. Comer the gentleman yields back. The chair recognizes mr. Grothman from wisconsin for five minutes. Mr. Grothman thank you much. Were going to give you another covidrelated topic. Throughout the covid epidemic i spoke multiple times on the floor with regard to the value of vitamin d. The adequate level of vitamin d varies on who you talk to. 20 nanograms, 30, 50. Whatever the study you look at, the number of lives saved if everybody had adequate levels of vitamin d is tremendous. Ok . Its a relatively cheap vitamin. But for whatever reason, it was not pushed by the medical establishment and resulted, in my opinion, in the deaths of hundreds of thousands of people. Even the most moderate studies would say youre less than half as likely to die of covid if you had adequate levels of vitamin d and if you get up to around 50 nanograms, you have a very, very small population dying. Could you comment on why the medical establishment, including yourself, by the way, another thing that bothers me, if you went in for a checkup, medical checkup, during that time, they wouldnt even test you for vitamin d. Which isnt all that expensive. Because you get blood tests for other things youre doing. Could you comment on the lack of emphasis of the benefits of vitamin d given that the evidence appears overwhelmingly helpful and very cheap . The lack of emphasis from the Public Health establishment on having vitamin d . Mr. Califf well, as ive already said, you know, as fda, this is really not in our domain. Vitamin d is available on the market. We dont regulate the practice of medicine. Thats determined by the medical profession and other agencies may have more to say about that but i would point out one key thing about vitamin d. Just a very basic in my role as a person who has done Clinical Trials all my life, there are many diseases for which if you measure vitamin d levels, the higher the level the lower the , risk of the disease. It turns out when randomized trials have been done, where you take equal people and give some vitamin d and others a placebo, for most diseases turns out there is no difference. Thats because people with higher levels of vitamin d are different in many other ways. They tend to be healthier and spend more time in the sunshine and all sorts of other things that are different. And the randomized trials so far on covid to the best of my knowledge have not been positive but i want to make the point, this is not something the fda regulates. Its a dietary supplement basically, a vitamin. Its on the market, its freely available in your local store and thats between the doctor and the patient. Mr. Grothman id like to submit a couple of columns here and ill yield the remainder of my time to the chairman. Mr. Comer without objection, so ordered. Commissioner, i want to ask this question about tobacco. With tobacco and fdas center for Tobacco Products, i think its safe to say the current regulatory process at the ctp is not what congress envisioned when it passed the Tobacco Control act 15 years ago. From the Reagan Udall Foundation report commission and recent court rulings, i have to conclude that those seeking to play by the rules dont even know what the rules are. Because fda wont tell them or fda wont put information out or they will put information out and then change it. So now after 15 years, fdas granted only 45 authorizations out of some 26 million applications and only five authorizations for modified risk Tobacco Products. While fda rejects applications based on science and data from manufacturers who have spent untold millions to comply with what they think the rules are, American Store shelfs are overflowing with products from china. And your agency does not seem to be doing anything about it. So, given what i just described, i have to wonder, do you even want a functional regulatory process for these products or is it the objective to target the u. S. Tobacco industry, even if it means allowing a flood of chinese products containing god knows what into this country . Mr. Califf mr. Chairman, you know, youre from kentucky, im from i grew up in South Carolina. Lived in North Carolina and i was a cardiologist at a Major Medical center. I saw many, many people die from the ravages of tobacco. So the basics here, first of all, the major cause of remedial death in the United States still today is tobaccorelated illness. 460,000 people will die from tobaccorelated illness this year. So were very much intent on doing the very best job we can, starting with combustible tobacco and the good news is, as i said in my opening statement, we have a decline in that. What was not even present when the initial law was passed that you refer to was the presence of vaping or ecigarettes. No one anticipated there would be 26 millionplus applications of vaping products. That is overwhelming. The good news, were 99 done, including almost completely done now with the major manufacturers. So the onus Congress Gave us was a Public Health standard. When it comes to vaping products, its the benefit of helping adults reduce use of combustible tobacco, the major killer, outweigh the risk of teenagers and children getting addicted to nicotine which is a brutal, fierce addiction thats almost impossible to shake once you have it. And so far only 31 products last i counted have produced the evidence to meet that Public Health standard. All the others you refer to simply dont produce the evidence. Now, if i could say a word about enforcement. I know that was the other issue. It bothers me as much as it does you to see whats on our shelves. But i do want you to know that we really picked up our enforcement. Over 600 warning letters to manufacturers. Hundreds of civil money penalties now and weve also now begun to do injunctions to stop. But every one of these cases, in an environment where every step we make ends up in court in complicated lawsuits have us go back and take that into account. Its a battle every day. Were engaged in it and we want to regulate it. The closer we can get to zero combustible tobacco the better. The role of vaping is still something were working on. Mr. Comer well get back to that. My time has expired. Ill have another round of questioning with that specifically. These products on the shelves that are getting the bad headlines are chinese products. That arent even regulated by the fda. Fdas regulating american companies. But the Chinese Companies are the ones that are the bad actors. So well get back my times expired. I now recognize ms. Norton from washington, d. C. Well get back on that too. Ms. Norton. Ms. Norton thank you, mr. Chairman. Mr. Califf, across the nation and right here in the district of columbia that i represent, drug shortages are negatively affecting patients and their families. Drug shortages can lead to daily challenges for patients, affecting every element of their lives, as well as health outcomes. For example, because of shortages, an adhd medication, we have heard reports previously, of previously capable students barely able to pass grades. Adults are forced to contact every local pharmacy to track down a medication that may be the difference between being productive and focused in the workplace on losing their livelihoods. Drug shortages have occurred for decades and in the wake of recent shortages, the department of health and Human Services and the food and Drug Administration developed new proposals to prevent and mitigate shortages. Earlier this month, hhs released a white paper with potential policy solutions to address shortages. Mr. Califf, what shortages can the fda execute to mitigate drug shortages . Mr. Califf thank you so much for the question. Ill try to go quickly here because we spent so much time on this. This has been going on for decades. And most of what the fda do is to mitigate impending shortages when we know one is about to happen. But the way we do that right now is we have spotty pieces of information about whats going on out there from the manufacturers and we spend a lot of type on the phone finding spend a lot of time on the phone finding out what manufacturer b to make up for what manufacturer a cannot do. Weve given you a comprehensive list of the information we need. Remember that most of the starting material now for our drugs is coming from china. The key Petro Chemicals that lead to drugs. India is a major player in the generic drug industry and so the supply chains are complicated and we only have bits and pieces of information. We need more of it. You referred to other drug shortages and it may be worth quickly going through this. I do not want to take up all of your time. But i think of three kinds. The most common shortages by orders of magnitude are inexpensive, generic drugs. Where, believe it or not, the price is not supporting the cost of manufacturing and distribution and quality. And the white paper you refer to as a lot of detail about this in it that i would refer you to. Our supply chain pricing has hit a point where the price is below what keeps the manufacturers in the game. When we do an inspection and find a problem and a supply line shuts down, that company may very well go out of business. Now thats very different than the shortage of ozempic which you referred to. There the manufacturer is making a huge amount of money with every dose. Its just that the demand is so much higher than they anticipated. That will take care of itself over time. But you also referred to adderall which is a stimulus for adhd. Very important because these drugs are highly effective for this problem and its bad for students that have adhd to not be treated. Unfortunately the very same chemicals are showing up increasingly in Overdose Deaths, the over 100,000 Overdose Deaths we have are typically a mixture of fentanyl plus something else, often a stimulant. The supply of these drugs is determined by the dea, not by the fda because its a scheduled addictive substance. So its a much more complicated issue. The generic one is the one that we hope that we have now solutions in this white paper that have to do with fixing the economics of that industry. Remembering that its not just americans, the eight billion people in the world need a reliable source of generic drugs. For the world, these drugs are really important to treat the chronic diseases that were referred to. Right now in most low Income Countries, we just heard from a foundation that 80 of antibiotics in one country were actually fake drugs. So we have to have an industry that produces high quality at a low cost with a supply chain which is completely known and we need the data so that we can actually help intervene when there is an impending shortage like a supply line goes down or a company goes out of business. So weve asked for that and i hope we can get it. Ms. Norton my time is expired. Mr. Comer thank you. The chair now recognizes ms. Mace from South Carolina for five minutes. Ms. Mace thank you, mr. Chairman. Commissioner califf, thank you for being leier today and thank thank you for being here today and thank you for your work on scheduling reform and your recommendation that cannabis should be moved to schedule three. While i and many cannabis advocates believe this does not go far enough, this is a long overdue start. So my first question today is i understand this issue now rests with the dea and im curious if you have an update on the timing of their decision. Mr. Califf were both from South Carolina. I dont even know. But if i did, i couldnt tell you anyway. So the timing of the regulatory decision is something that would be up to the dea, not up to me. Ms. Mace do you think it will happen this year . Have any idea . Mr. Califf i know that theres no reason for the dea to delay. I think they just have to take into account all the regulations that are in place. Ms. Mace ok. Thank you. If the dea concurs with the fdas recommendation, can you help me understand if the fda will take on additional responsibilities or if your role will change as it relates to cannabis . Mr. Califf this is a very complicated topic but ill just say that cannabis, you know, remember, there are over 30 different forms of cannabis now, different chemicals are made and it falls in this area where state regulation has been dominant. This is an area where i believe we would be better off if we had guidance from congress about how to proceed. Because were not medical marijuana is one thing where theres a medical purpose and its proven through traditional medical pathways. But when its used for recreational purposes, there is no medical benefit in that case. So it doesnt fall under our typical regulation. But whats in play with this and several other things that i think well probably talk with the chairman about here shortly like cbd, the question is how do , we reduce harm thats done when its used inappropriately or a dose which is dangerous . Or when its packaged in a way to market it specifically to children . Were seeing some of this stuff packaged in gummy bears that easily mistaken for childrens candy. But were going to need help in a regulatory pathway, remembering that almost everything we do, theres a health benefit. Like you create a new drug or a new device or a food for a health benefit. This is an area of Harm Reduction when its used recreationally. Ms. Mace right. Well and also, it reduces the morbidity and the addiction to opioids prescribed by doctors , too. Theres just a huge amount of benefit. Ive seen it benefit in my own life and welcome to my world, im a mom of teenage kids. Ive seen packaging of things, i see what kids are bringing to school, even in a state that prohibits cannabis, kids are doing it all over the place. And i have a bill called the states reform act. Theres a balance between federal regulation and also regulation amongst the states but one of the things you mentioned was about packaging. Myself, like my colleagues, were concerned about the safeguards for our youth and one one of the things in the state reform act is it addresses the packaging that should not be marketed like its candy or a candy bar or chips or whatever kind of candy is your favorite. In South Carolina i understand these products, so im concerned about safeguards for youths and intoxicating hemp derived products. In South Carolina these are not agegated or appropriately tested and many of the packages resemble candy or snacks and that sort of things. So for my family its an ongoing conversation about what looks cool and looks like it might be a fun and exciting, really is not, especially on a young brain. Mr. Califf without revealing too much about my age, im a child of the 1960s. It would be nice if in my lifetime we came up with a regulatory scheme where i think, whatever your belief is about use of the product, where these safety issues that youve referred to are written into law so that we have a scheme whereby we can regulate it. Because if it is not written into law like i said, were , referees. You write the rules. We need the right rulebook in order to play the referee role. Ms. Mace i would encourage you and love you to review the states reform act that takes into account the regulatory side and the federal side but also states being in the drivers seat but again one of the impositions of the bill is addressing and ensuring that we do not market to kids. Things arent packaged to children. I only have 20 seconds left. While i firmly support the right of americans to make choices about what to put in their body, we can all agree it is a desirable outcome for less people to smoke cigarettes, the negative Health Effects of which are well known. Any comment on alternative nonNicotine Products today while you are here in five seconds or less . Mr. Califf theres several categories. Medications is one category where i hope well see more in the pipeline, its not robust. When it comes to chemicals that are synthesized that also cause activate nicotine receptors, they also cause addiction to nicotine. So weve got and the inventiveness of entrepreneurs in this area is profound right now because chemistry has gotten so much better. So theres some things im very concerned about in nontobacco nicotine and even compounds that are one component removed from nicotine which may even be more potent in terms of addiction. Ms. Mace thank you and i yield back. Mr. Comer the gentlelady yields back the balance of her time. The chair recognizes mr. Lynch from massachusetts. Mr. Lynch thank you, mr. Chairman. Dr. Califf, welcome, thank you for your good work. In march of 2024, the fda issued a proposed rule regarding electrical stimulation devices that are intended to reduce or stop selfinjurious or aggressive behavior in some patients. If finalized the proposed rule , would remove these electric stimulation devices from the market and the devices will no longer be considered legally marketed. Ive tried to read as much as i can on these. As an attorney i try to refrain from making medical decisions on my own. Especially for my constituents. I do know that the Geneva Convention regards these devices as torture. But i also have a group of families in my district who have children and loved ones who are undergoing these treatments and they claim that those treatments help. Now, as a result of this rule, these treatments will go away and my constituents have asked me to ask you and the fda to meet with them to talk about the consequences of the fdas rule. And so as a member of congress, on behalf of my constituents, im asking you and all your staff to provide an opportunity for those families to meet with you and to discuss their concerns. Mr. Califf well, thank you for bringing this up. I know its part of your duty to do so. This is a very tough issue and i have worked in psychiatric wards during my career and i think most people can appreciate the anguish of families who have loved ones who are in a situation that might call for this or other Serious Mental Health problems but anyone who has been through it i think has a special feeling about it. As i think you know, theres a proposed rule that weve now put out there, a docket and we do encourage everyone to submit their comments and views to that docket. I will definitely take this back to our staff. I know that our staff has met with these families before but this has been going on for a while so well go back and reconsider. Mr. Lynch it has and its heartbreaking. Let me ask you, so, shifting to something completely different. Last year the fda made nearly 200 additions to its public list of ai and Machine Learning enabled medical devices currently marketed in the United States and theres been some wonderful success. Dana farber Cancer Center is near and dear to my heart. Mass general brigham, their Cancer Center as well. Wonderful, wonderful progress in diagnosing Breast Cancer from mammograms. Clearly there are enormous potential benefits here. But theres also some concern around privacy and also the lack of explainability of some of these algorithms that are being used on a diagnosis or the predictive end. What are we doing to mitigate the negative aspects of the use of ai, and i know its coming at us hot and heavy in so many areas, but id like to hear what the fda is doing about guarding against the dangers that might be present by this Widespread Adoption of ai. Mr. Califf thanks for the question. Ill have to contain myself here because you may know i worked at alphabet or google during the years between my fda stents and i was very heavily into this and i think its going to be a huge benefit but also a huge risk on the other side if its not regulated. Also, we have many mutual friends. Ill be at mass general next week as visiting professor and learning from the people in the harvard system who know a lot about this stuff. This is one of the topics. The thing i would emphasize is that i dont think its explainability thats really the issue, and i think an easy way to think about this think about , it yourself before you had a map in your car that you could talk to. When you used to drive the car and you get in an argument about which way to go and then youd have to pull out the map and look at it. Well, now you just talk to your car and whats going on with the car is ai continuously in realtime take into account everything thats happening on the roads, the template of whats there, and your personal preferences that it learns as you go along. I think if a. I. Works, well take it for granted. There are many things we do in medicine. If you ask me how does aspirin work. We know a lot about aspirin. But how it works for each disease we are not sure. We know it does work for particular things. What we are focused on is creating a community in our Health Systems and the industry that, like i have already said, we are referees, we think the first line is selfregulation by the industries. Whats really important, where ai is going, generative ai learns as it goes. The more information it has either the better it gets or the worst it gets. You dont know which one. If you just put it in place and dont tend to it and monitor it, it can go wrong in really bad ways. I saw that at alphabet. It was something we were worried about. So we have to reformat our Health System so that as time goes on you are constantly looking at what the algorithm is doing. Are the predictions accurate. That is really the key thing we have to do and right now we are not configured to do that. We are working very much with the community of Health Systems and the industry to come up with a scheme of whats called assurance labs. This would be, you sell your ai thing to somebody, it goes out there, theres going to be a monitoring that says its either working or its not in practice. It also looks for the bias we are all concerned about that if you put the wrong information in you end up with a prediction which is preferential to one type of person compared to another. Thats got to be looked at. Ill stop there. I could go on a while. Mr. Lynch thank you for your answer, doctor. Mr. Chairman, thanks for your indulgence. I yield back. Chair comer the chair recognizes mr. Sessions. Mr. Sessions commissioner, thank you for taking time with us. As you know the cardiologist spending time in Mental Health stress units. Part of what im going to talk with you about we come directly to observations that you may strongly identify with. In august of last year, assistant secretary for Health Levine sent Drug Enforcement Agency Director and mel graham a recommendation from the fda to downgrade marijuana and thc from schedule one to schedule three under the controlled substances act. This recommendation made the claim that marijuana meets the criteria for control under section 3. In reviewing the fda recommendation, i believe the fda did not base its assessment in scientific fact or realities of how marijuana is being abused and used in our country today. The fdas assessment relied on, i think, cherry picked data. For example, concluding in the report that since the potential for abuse of marijuana is less than heroin, marijuana should be downgraded. This completely ignores the realities of a drug that is causing enormous consequences of children and adults in our country. High schools, middle schools, and communities. Just last week bloomberg Editorial Board published an article emphasizing the sharp rise in marijuana thc related traffic fatalities. One analysis which is consistent with the hidta report out of colorado, a 10 increase in vehicular deaths. In california, the increase was 14 . In oregon, 22 . Nearly 50 of the deaths on a highway, the driver had thc in their blood. Those are only the marijuana related traffic deaths that is we know about. We know that there are other problems. In your agencys analysis you scrap the long held five factor test for determining a drugs medical necessity to simply two factors. Two factors that relied on the fact that marijuana as was reported currently is accepted for medical use because it is prescribed by Health Care Practitioners through medical marijuana programs. So what i would ask you is why did the fda create a new less rigorous two factor test when you know the reams of data and evidence suggest its not only addictive, but a contributory to not only death, but longterm stress of people who use this and confirmed by the medical community . Dr. Califf sir, i appreciate the question. I think you have already demonstrated between you and the other representative that there is not agreement in congress about what should be done with this. Again, we would very much appreciate if congress did come to a conclusion for the country. Mr. Sessions congress has not spoken because we believe its a dangerous product. We receive calls from thousands of parents every year about their children. We see drug related not only instances in schools but principals, teachers, people report the real problem. And the problem gets even worse as gummies are introduced. It certainly appreciate those concerns. Let me remind you that a schedule three does not put marijuana on the market in the United States. Mr. Sessions but you do know exactly what it does do and you suggested that its not a dangerous product like heroin. Neither were cigarettes like heroin. Dr. Califf i think it is differential from heroin then cigarettes to cause death. I appreciate you think that way and you probably gave the opposite point. Mr. Sessions she talked about the public opinion, you are a medical doctor and i thought you are here to answer and i thought you did do a good job where when not used properly, it is a dangerous product and it is a dangerous product. I thank you very much and i appreciate you being here today. Mr. Chairman, i yield back my time. Thank you, mr. Chair. In february of 20 to me when i was chair of this House Oversight subcommittee economic and consumer policy subcommittee. We studied the toxic heavy metals in baby food at the time. In march of 2021 we issued a report with regard to the presence of lead, arsenic, cadmium and mercury at astonishing levels in baby Food Products. We found that baby food had, on average, 100 77 times the permissible amount of lead in drinking water. In response to public pressure coming off that report, fda issued an action plan called, closer to zero. This was the first time fda would be regulating toxic heavy metals in baby food, which is a good thing. When my subcommittee issued its report in march of 2021, fda said it would issue its initial draft guidance regarding permissible lead limits in baby food within one year, so roughly april 2022. Instead, it missed the deadline and issued its draft guidance in 2023. That me talk to about the other heavy metals in baby food that are covered by the closer to zero program. I want to throw up a screen shot at your website from today. Specifically, i want to talk about when you say final guidance will be issued with regard to permissible limits of other toxic heavy metals. In terms of when there is arsenic in baby food would be examined and you would be issuing final guidance on permissible levels, your website says, and this is my red circle, no update. Thats what it says, right . Dr. Califf i will take your word for it, i cannot see it from this distance. Let me talk to about cadmium levels. Screenshot from your website today, you say that we should expect final cadmium levels at some undetermined point. Again, your website says no update. You dont disagree with that, right . Dr. Califf im not up to date on the exact but i will assume you are telling the truth. Thank you. Mercury, a dangerous toxic heavy metal in baby food. Again, we go to your website, and with regard to when we should expect to hear from you, with regard to permissible levels of mercury in baby food you say, no update, right . Dr. Califf if you say it, it must be so. This is unacceptable. Completely unacceptable. It has been three years since we issued that report. The public, the parents are outraged about the amount of toxic heavy metals that are present in baby food. Quite frankly, i respectfully say youre closer to zero program and its close to zero day. And thats very, very disturbing. I want to turn my attention to another topic, which is the youth vaping epidemic. You and i have spoken about this before as well. Your own 2023 survey indicates 10 of middle and High School Students are vaping today. 90 of them preferred flavored ones. The vast majority, the vast majority of the flavored ones are illicit coming from china. Here one of those illicit illicit ones right here. Its a strawberry mango create, and its illegal, but you can buy it today because you folks have not clear the shelves of these illicit products. On december 7, 2023, a dozen of us wrote to you asking for a comprehensive approach for dealing with these illicit chinese vapes and you did not respond to me at that time, did you . Dr. Califf i have to go back and look but weve had much correspondence about this issue. You are too busy to respond to as, it has been five months. After that we road you wrote you february 4, 2024. Again, same issue, how will you deal with these illicit vapes coming from china. You do not respond to that one either, right . Dr. Califf id have to go back and look. What bothers me about your answers is this, the reason why you didnt respond to us with your approach with clearing the shelves of these illicit vapes from china is perhaps because you dont have an answer, its because you dont have an approach, and mark my words, the illicit vapes coming from china, flooding our market, kid friendly flavors, such as the ones here or the ones i hold in my hands is the next chapter of the youth vaping epidemic and its time you take this seriously. Thank you, i yield back. Quite gentle man yields back, the chair recognizes dr. Fox. The center for Tobacco Products must make timely decisions on a product, especially tobacco Harm Reduction products. However, stakeholder groups with pending premarket tobacco product applications have been waiting for several years to a decision, which far exceed the 180 day review written into law. Can you tell me in 25 words or less, why has it failed to comply with the statutory review time despite the fact that this staff has more than doubled in the last decade . Quick to say less than 25 words, is 26 plus million applications. Were now 99 done and soon we will be within that timeframe. But you know those are very frivolous applications and there is a couple of dozen in there that are coming from legitimate places, and you all should have focused your attention on those. Its hard to believe that an agency thats doubled its staff over a decade receives over 700 million per year with funding is still not meeting the deadlines for these, the serious ones, again. Its my understanding relatively few from legitimate companies. What steps are needed to bring more accountability to the ctb . Dr. Califf i would remind you that the vaping industry pays no user fees, so all the money and people that are hired are hired off of the combustible product industry, then we have tremendous gains. In terms of the transparency for the applications, people can track it, the information is published, and Continuous Improvement in our efficiency. What performance metrics does it have to ensure they are being good stewards of the tobacco user fees . The numbers of applications, the time it takes to review them, the outcomes of of the reviews are discussed by numerous watchdog groups that are looking at everything that we do. Has a dentist job over the last decade there should have been tobacco Harm Reduction products approved through the appropriate process. Theres clearly a demand for these product that is being filled by illicit flavored disposable ecigarettes now making up more than 70 of the ecigarettes or in market, as my colleague is talking about, most of which are from china. What is the fda doing to rectify this problem of the products in the market . If i may, tobacco Harm Reduction product is an industry term. Id say we are all reducing harm from tobacco. And as i went over with an earlier question, we have an increasing number of warning ladders, civil money penalties and injunctions and seizures now at places of import. It is a very large number of products, there is no question about it. It is a big job and we have a lot more work to do. Commissioner, you have recognized the critical need for the public to have access to accurate medical and scientific information to help inform the decisions they make about their health. How does the fda justified the decision to spend millions on ad campaigns and scare tactics such as rain warms or metal dragons that are not based on their fax, and when will the fda focused on the facts about what can make cigarettes deadly as congress intended in this Tobacco Control act instead of relying on misunderstanding and outdated narratives . Im not sure i follow that question, i would just say we have seen dramatic reduction in tobacco use, significant reduction in the number of people dying, although still 460,000. I will just note that in my time , i learned a lot about advertising. I think our statements are based in fact and they conclude a component to reach into the culture of people that to recei. Start by giving two sentences on what the fdas orange book is. Dr. Califf the orange book is a listing of packets that are relevant to drugs that are marketed. Correct. If something is listed on the orange book, is it correct that for 30 months, hm and a generic manufacturer cant produce that . With some caveats but essentially its a fair statement. You have a multiple sclerosis product produced, it cost patients between 3000 and 50,000, and it is currently listed on this orange book. The company producing it is going to come to have it listed with no real changes to the drug, cosmetic changes. If they list it again, no generic manufacturer drugs can be produced for 30 months . Dr. Califf its a little more complicated than that. You left out one step before that, which is you have to have a pattern, which says its a significant new thing. Our role in the orange book is ministerial. You have discretion on whether to listed or not, correct . Dr. Califf not much. But technically you have that discussion. What would happen if you did not list them . Dr. Califf we would get sued. Whats happening as you have companies that are getting you to list this and not have generic competition, as a result, the American People are paying 60,000 for drugs on multiple sclerosis. Or in the case for leukemia, they are paying 17,000 because you are listing something in the fda that is in allowing generic competition. You can say the blame is in the Patent Office, but if those were not listed at the fda, you would have generic alternatives, is that not correct . Dr. Califf my grandfather was a baptist minister, we are all sinners. So we will take our share of blame. It is between us and the Patent Office to get rid of frivolous patents, just to extend the time. Would you say in the case where they are asking for more patents and multiple sclerosis patients are paying 3000 to 50,000 could be frivolous. Or they have 27 patents to treat leukemia, there could be some of those being frivolous . That decision really is an ftc decision. I have personal opinions about parts of this. There are too many efforts made to extend patents. What about for astrazeneca in the inhale court inhaler . I cannot refer to a specific one. My mom got extra Life Expectancy due to it. Im very familiar what happened with the cost. My question is, what can we do in congress because this is frustrating people. Im not blaming you, but im saying you have a system where you are listing these drugs, maybe youre saying your hands are tied, its not bringing those costs down, and we keep getting, from the American Peoples perspective, how do we solve this. If you give me 10 seconds, do you have a recommendation . Dr. Califf we are the referees. It may be something where our staff will have to get together with yours and the Patent Office to see if anything can be done for the law. The last question i want to ask you, i know when you are in the fda and afterwards, you got consulting fees from astrazeneca, bio jan, i take you at your word that there were ethics reviews and then you said there were no ethical conflicts. But members of congress should not become lobbyists. We do commit today that after your service of the fda chair, you will not make any money is consulting fees from big pharma going forward. Dr. Califf i have a written record on this for two years. Beyond that point, we will have to see. Why not just make that commitment so the American People are confident. You can make plenty of money at google or somewhere else. Why not just say i wont take big pharma money . Dr. Califf im not looking to make money. Why not saying you wont take it after regulating it, just make that commitment today. Dr. Califf i certainly have made the commitment for some time, but i cannot speak for the rest of my life. I think you should. Dr. Califf i appreciate your opinion. The chair recognizes mr. Fallon from texas for five minutes. I think we had bipartisan agreement i would love to coauthor any bills you have. I think its good government. Thank you for that. Thank you, mr. Chairman. Im here not as a member of congress. I wanted to visit on a few things, particularly, i have two teenage boys and i see that teenage vaping is skyrocketing. I think its entry to some really nefarious habits moving forward. Im concerned about the use of illegal and unregulated chinese vapes that was touched on before. And the fda contributing to this proliferation we see across the country. The Tobacco Control act of 2009 created freemarket, review process allowing for a new Tobacco Products to enter the market. As myself and 60 colleagues pointed out in a letter we sent to the president last month, a letter led by my good friend congressman richard hudson, despite the fda receiving over 26 million for smokefree applications since this law, the fda has authorized fewer than 50 products applications with less than 10 being commercially available. There is a time where they have authorized thousands of combustible cigarette product applications. But as of january of 2024, there are only 23 authorized ecigarette products by three manufacturers. The fdas ability to process the em teays in a timely matter has illegal chinese vapes letting the market all over the country to meeting consumer demand. Often in flavors that hopefully you agree are horrific in flavors as they appeal to kids. Each flavor watermelon. A flavor by a widely properly brand. The Chinese Company vapes are you legally here. Yet easily purchased at local stores. In fact, smoke shop over in virginia, this picture was taken two days ago and you can see, in the yellow, those are all illegal chinese vapes along the wall. When i speak about hypotheticals, this is flagrant noncompliance. This was randomly discovered by the inaction of the nda. Almost a prohibition on legal products. Then, by further weak action on enforcement, u. S. Tours of no concern about openly selling the product. Commissioner, bylaw, how long does the fda have to review it and take action . Kwuex 180 days is legal. Corrects, how long on average does it actually take . Dr. Califf its hard to calculate, there are 26 point something million applications and some are still outstanding were obviously not meeting a 180 day timeline, although, its getting better. It is 99 complete, which still leaves hundreds of thousands. The stakeholder told us it is three years. Is that feasible . Dr. Califf remember the history. When i was commissioner in 2016 it was when vaping was starting. They went to millions of products. There were some laws in between. Its the case that there was such a lot of products that if you went back three or four years ago you would say, three years until now. But if you look at the applications coming now, its shorter than that. The fdas website said it took roughly two and a half to three years for each one. Dr. Califf there was an effect that had to be dealt with as one of your representatives already pointed out, millions were taken care of that didnt have useful data in it. You should have a Regulatory Framework in place and morning letters are one thing. How many seizures have we had at retail shops crosscountry . Dr. Califf we have only had a few seizures. 32,100 civil money penalties, and those are ramping up considerably it considerably as we go. Seizures require a whole different order of magnitude of legal work. We only have a few seconds left. These are all over the place. What do you think the fda could do to mitigate this . Dr. Califf given the fact that there is a vapes shop in almost every neighborhood, it would take a lot more people to do what you are saying of clearing the shelves. We have an action plan, it will get that are in better. The user fees were paid by the vaping industry. That would be about 100 Million Dollars and we could hire a lot of people and spend more time in the shops. Im not trying to suggest that every illegal chinese vapor will be taken from the shelf. You can set up set examples and make examples. You can yield back. Gentleman yields back. The chair now recognizes maryland. Dr. Califf they q very much thank you very much mr. Chairman. Before i go into my observations. Let me go back to something the Ranking Member said earlier that i dont want to get lost. That is maybe what we ought to be doing in addition to this is trying to find a way to create more regulatory pathways, given the fda the ability to do many of the things that you said you cannot do here today. Im deeply concerned about the over prescribing of adh medication, particularly ritalin and conservator as it relates to kids in poor neighborhoods as a means of dealing with their hyperactivity in school, and that so many studies have shown that whether they are poor black, poor white, poor latino, this over prescription seems to take place. Im not a conspiracy theorist, i just dont think Humpty Dumpty fell, i think it was pushed. So, moving under that premise, i think that unless we do have greater regulations over the overprescribing of these medications, it will continue. Let me flip that around to the other side. I am also deeply concerned about children who are unable to focus on things and are given these medications and where all the protocols have been followed, and im concerned about that because in many instances, those drugs, unfortunately, have been part of the shortage. Im concerned about Cancer Patients who are forced to delay treatment because many of the required medications are out of stock. So, those are just a couple of things im hearing from my constituents in baltimore on a regular basis. I know the supply chains were disrupted during covid and that there has been intermittent and sometimes not intermittent drug shortages appearing throughout the u. S. But i would be less than honest if i didnt tell you that some of the things that i hear. I recognize that youll carry a magic wand in your back pocket, the only thing you can do is to help guide us, listen to us and suggest ways we can help you. The fdas serves as an important regulator and it is well positioned to assess potential supply chain disruption. Can you tell us, this committee and the people around the country who may be watching these proceedings, how is fda working currently with manufacturers to mitigate the ongoing drug shortages and have those manufacturers, in your opinion, be transparent with the fda about potential shortages in the real root causes of those shortages . Dr. Califf first of all, what you said about the under prescribing in the overprescribing i think it exemplifies a major problem that we have. There is no doubt that people that need these job drugs are not getting them and people that need them or not getting them. That fda that equilibrium is not set by the fda. The quality issue that we need to work on and we are trying to help us best we. But your main question value the manufacturers is, we work every day with them and they are required to give us more information. They resisted as giving up the crucial information that we need. When there is a shortage, we are finding they are cooperative to Work Together to try to fix it, but it would be better if we had all the data we needed to put together a predictive algorithm to allow us to intervene preemptively and prevent this shortage. You will have a copy of the list with the correct information that would make a difference. I also want to point out that while there is a shortage, the biggest shortages are occurring and energetic generic drugs, the less expensive the drug, the more likely this shortage because of the way the market is not succeeding in rewarding highquality manufacturing. Thats the point i think we need to address over the next few years. Any guess as to what factors affect nongeneric drug shortages . Dr. Califf there are really only two major types. Its not a generic drug. The manufacturers making a handsome profit once the product is on the market. So theyre pretty good at figuring out how to make it. The exception is ozempic or the weight loss drugs where the demand is so high, they cannot keep up. Mr. Chairman, i yield back. Thank you commissioner for being here today. The university of arizona has been engaged in research that would advance pain and Addiction Research to help combat the opioid crisis. They are looking for ways to expedite known drug candidates to the face to face free trials to take nonaddictive pain relief for the market. Usa has informed me if they could repurpose clinical medications that are proven and also shown to be effective for treating different types of chronic pain. They think they are ready to go forward in these trials. But they also report theres a need to repurpose the medication. Because pain is differentiated based on sex, and that would have an impact on how to develop the drug. During the covid era, fda was able to accept Clinical Trials. This is phase ii and phase three Clinical Trials. Something that could leave you with chronic pain and help reduce the risk of opioid addiction that we see so rapidly. Could this be a statutory problem, a regulatory problem, a resource problem . What might we be looking at . Im giving a very specific sample but hoping you can give information. The way it works at fda and joes sister user fees we are meeting those timelines which are agreed to within the industry, the fda and then put into law by your passing the law. Im not aware of the particular circumstance you are giving. There is a thing we say at fda, in god we trust, all others must bring data. I have to know the data coming from the university of arizona to know if theres issue causing a backandforth that wouldve fall within the usual timeline. When that happens, its noted. We would love the opportunity to present you with additional information. Fdas responsibility is to ensure this regardless of where the drugs are manufactured. The inspections have been declining since 2013. Chinese and indian manufacturers have received most of the letters by far. These violations include contaminated medicines, and falsified data house the fda working to keep it accountable . Are already established we are doing a major reorganization because i agree we need to pick up the pace of the inspections we are doing. The first line of defense is the manufacturers. The more we can keep up with whats going on, not just in u. S. Facilities, but around the world, the better we target our inspections and have the frequency needed to keep manufacturing in shape. A big area is india where we have completely redone the inspectional system. I personally met with the Indian Government to work on the relationship so the inspections can proceed. I believe they are acting in good faith. The layer of data and information should constantly be coming in now that all manufacturing is digitized. On the human side, those are being increased and is a major form of emphasis in our reorganization. There arent a lot of bipartisan issue, but one thing is we need to have more domestic manufacturing of our pharmaceuticals. What can we do in congress to encourage in an environment where all of our essential pharmaceutical production is manufactured in the United States . Dr. Califf i was one of your colleagues pointed out, i dont to get the big issue for innovator drugs because that issue doesnt experience much in the way of shortage. But definitely but its a National Security issue. Dr. Califf absolutely. Fda doesnt deal with prices on the market. I would refer you to the hhs markup i we need to create an economic market system where the price is fair so the manufacturer can produce the product and invest in the technology of manufacturing and can be done using american labor, which is more expensive the labor and other countries. Im not talking about 100 reassuring, we need enough of a footprint in you the usn nearby countries. We are assured that if something goes on in the world, we keep this up. 95 of our prescriptions are now generic. Chair recognizes miss bush for five minutes. We are here to thank you for the work that the fda has done to release cumbersome restrictions on a drug used for medicated abortion. As the Ranking Member mentioned at the top of the hearing, it is subject to a risk strategy. The fda suspended a portion of the requirement saying it should be dispersed in person. We know in january 2023, the fda permanently updated the strategy to remove the dispensing requirement this has proven the in person was never medically necessary. Protecting axis to medication abortion act would assure that it does not have an in person disbursing requirement, allows patients to access their prescription and authorizes all to patients to do so via mail. Thank you to the fda for your commitment to evidencebased care that serves patients and not politicians. I wanted turned to sickle cell and it affects 100,000 people across our country, the majority of whom are black people in about 2000 people across my district. According to the cdc what out of every 365 black children in the United States are born with sickle cell. It cuts at least 20 years from life expect c. As a nurse i have treated people with sickle cell and people experiencing pain and it is debilitating. This illness takes over your life and it is heart wrenching that we dont speak about it. The fda issued the approval of the therapy to treat Sickle Cell Disease so this technology is the first time genetic editing has been used to treat any disease. Patients who faced excruciating pain and even death from sickle cell will now be able to better manage this lifethreatening condition. For many who may have been unable to hold steady employment, spend time with family and friends cannot participate in life because it is altering. This technology would be impossible without the science driven work of the fda. What did the fda consider when determining the news sickle cell treatment, determining that it is safe and effective . Dr. Califf there are two treatments approved. One using gina editing. Human Clinical Trials were done taking sickle cell patients, as you would know, being a nurse, people with Sickle Cell Disease, even though genetic diseases essentially the same as the human genome, the manifestation of the disease is different. What was done in these trials would think people are having the worst outcomes. That is many attacks, a painful crises. And then during the gina effort, following them after and showing the crises abated, almost completely, it was a remarkable result. But a Smaller Group of patients. Theres a lot you have to learn, but it was important to give access to those who would benefit. Is there potential for this new treatment to be used to treat other genetic diseases . Very exciting and i leave it to my opening comments. I was around for the human genome project. People for decades said, wheres the beef. We put all this money into it, now we are here because thanks to the signs, we can go in with molecular scissors and snip out the gene that is causing the problem and put in a new one, or snip out the gene thats causing the problem that we dont need to put in a new one. 10,000 Rare Diseases with no treatment. You are talking about parents of children who have terrible outcomes. This is such a resolution in terms of therapeutics that we are making major changes within the fda, but it has to go further than that because you are aware the cost of these treatments is quite high. So i think its going to be a lot for congress to work with the administration on to figure out, if you are a parent of a child with a rare disease now, theres hope that within a few years we could have an effective treatment, but if we have hundreds of thousands of effective treatments, the environment in which it has to look different than it does right now, i hope that is helpful. Yes. One last question, how can we ensure that people who require this genetic therapy are not out, like you started to allude to . I could take the easy route and say, on a hearing about fda, its not in our remote. But there are many discussions going on across hhs where, Sickle Cell Disease, the majority of patients arm are on medicaid because their medical costs are so high and difficulty with jobs in a case where you are sick a lot that we have to come up with new pricing schemes. I am a Health Policy person. I would be glad to talk with you separately. I will reach out. Thank you mr. Chair. Greg thank you, thank you for being here. Your authority is a fast and your responsibility is great, you are a gentleman of distinguished stature. I appreciate you being here today. You have to give serious answers to hard questions, and i do have hard questions to submit. I will submit the more interesting questions in writing, for the record, after the hearing. For legislative purpose, i have a specific line of questioning regarding imported seafood. There is a matter of background, according to my research and investigations, about 60 to 65 of seafood consumed in america is imported. Generally speaking, given the limited resources that you have at your avail, you are able to supervise the inspection of about 1 10 of 1 of imported seafood. Is that generally correct, sir . Dr. Califf by our account its more than 65 of seafood. This is the republican side, so im being conservative. Dr. Califf as much as i described on the drug side, it starts with a digital inspection. We have information about these facilities. As it comes in, we use Artificial Intelligence now to look at the characteristics of the shipment to pick out. Its not just the small number you referred to out of overall. Its a highrisk part of import. I appreciate that level of expertise and of course the dynamics of i appreciate that level of expertise and the dynamics of your legal imports would include inspections beyond the biological and chemical realm but according to september of 2017 gao report titled imported seafood safety, fda and usda strengthened efforts to persuade, to prevent unsafe drug residue in imported seafood. A whistleblower has come forward indicating a Company Called choice candy, in indian shrimp exporter has knowingly shipped antibiotics contaminated shrimp to the United States despite this, fda data shows 21 shrimp samples from this company have been tested since 2,003. To put this in perspective, respectfully, you have a massive job to do and limited resources. I want to help. This company that im referencing, the Choice Canning Company which was a choice via letter imported 24 Million Pounds of shrimp to the United States last year alone. Imported seafood coming into our country, billions of pounds, very little of it has been inspected at the Laboratory Level for biological and chemical contaminants. The reason we are not getting sick is because we cook the seafood. That the reality. I would like to ask you. If you have legislation from this body that gave you teeth in enforcement, the mechanisms to destroy shipments that were found to be contaminated, would that be helpful for fda enforcement that violates american standards for biological and chemical contaminants . You ask the question in a specific way that im reluctant to say just yes. I would say in the general direction you are going including this arena, the industry has fought our ability to do what you described. It is not just true in the area you mentioned but in general, i believe we would exercise our authorities responsibly and more quickly take care, there is stuff that sits there for a long time. I am going to close by saying my intention is to legislatively empower the fda to have aggressive responses to shipments of contaminated seafood. I yield. Im a south carolinian and i think our shrimp is better than yours, nothing i would like better than have a resurgence of the seaFood Industry. I learned from a young man not to argue with a gentleman and a bowtie so i will let you have that. Miss dans very from new mexico for 5 minutes. Thank you, mr. Chairman. Thank you, dr. Robert califf, for being here today. I want to thank your staff are being here as well and im grateful for the opportunity to highlight the importance of science, and sciencebased Decision Making in this hearing and all that you are doing to protect the American People to ensure that we have access to medicines we need, food that doesnt harm us and to ensure every american can get lifesaving care and for your work, and the administrations support to pass once in a generation legislation to expand access to healthcare and science and innovation and access to Prescription Drugs for seniors. The fda is on the front lines of that battle every single day and we are grateful for the work that you do and on a personal note i have a Family Member who was formerly in fda employee and you represent the best of the best our country has to offer and nowhere is this more important than in the realm of reproductive care where we have to continue to follow the science and ensure reproductive freedom especially in the face of unprecedented attacks. As weve seen republicans in this body, in this room and across the country have been working to ban abortion first or Donald Trumps Supreme Court which overturned roe versus wade last summer and chipping away statebystate temperament abortion bands including in arizona where just this week the court upheld the civil war era abortion ban. For folks who dont know this, this ban was put in place in 1864, before end to slavery had been ratified by this body, before women could vote, and before arizona was even a state. Lets be clear. No judge, no politician, no person should be able to tell a woman, and a woman in america or anywhere in the world what she can do with her own body and knowers this more important right now than in the United States Supreme Court which we are all watching very carefully in the wake of their hearing of oral arguments in a case in which the fda has been involved in the last several years. So i want to ask you a question, if you could talk about not only the implications of the decision by the Supreme Court which we are speaking this summer for women to access reproductive character medicated abortion but also what are the wider implications for fdas ability to use science to approve medicine . Thank you for the question. This case is under consideration by the Supreme Court. Im very limited in what i can say. I will say that we stand by our decisions, they are still in play today and i will add that we do have concerns if judges start secondguessing fda decisions about what that means for the broader area of having a rational system of availability of medications and devices for the American Public. The fda approved mesocristone to issue around reproductive care and the broader implications are if judges start legislating from the bench on this kind of medicine it could be anything. It could be transit treatment, any kind of medication or intervention your health and i think the American People need to understand the implications of this case, potential impacts for Public Health and the ability for to impact every americans opportunity to access lifesaving care. We appreciate your work and i am personally thankful to be from a state, new mexico, that is worked to protect reproductive care but if the Supreme Court does overturn fdas decision to approve that medication this summer, we could see a ban on medicated abortion across the United States including in places like new mexico where it is protected so thats why this body has to urgently take action, why we have to defend the science, we have to defend our agencies are making sure that american women and all people have access to the care that they need and why we have to do everything we can to defend our institutions because the lives of our communities literally depend on it. A comment if i may. Everywhere i go in the world, our system of Drug Development and decisionmaking is the envy of the rest of the world, they want to be with us. Ive already commented, our use of generic drugs and Public Health has fallen a little short with our drop in Life Expectancy. The system you described is one thats very important we serve in general or in addition to the topic you are specifically talking about. The chair recognizes mister parry from pennsylvania. Thank you. I want to talk to you about the world health organization. My name is all kind of things but dr. Robert califf. That was an incorrect pronunciation. That was plain wrong. I want to talk to you about this treaty, one hundred 85 plus nations including places like yemen, iran, iraq, afghanistan, cuba, haiti, some terms in that, we havent seen it. We havent seen the 30 plus amendments, we are shooting in the dark and i dont know that you know more anymore than the rest of it than we do but there was another draft just last month that created a multilateral system for sharing pathogens with pandemic potential. I listed some of the countries involved. It also commits each party which would include us if we were signatories, to produce access to evidencebased information on pandemics. The aim there, i guess is to combat misinformation and disinformation, as you see it or as they see it. My question, is with the potential threat to us sovereignty for decisionmaking on whether pandemic even exists and the prescribed remedies including lockdowns and even medicating, would you commit before the committee today to pledge not to adopt policies pursuant to the treaty until such time and if such time that treaty would be ratified by the United States senate . Im not sure how to answer that question given the complexity of what you said but it is hard for me to imagine we would do something fda thats not a government policy. You refer to the senate in particular. Of the senate doesnt ratify it, it wouldnt be a pretty we wouldnt be signatories to or at least not legally and i want to know if theres any intention by the fda to institute provisions within the treaty without proper ratification from the senate. I dont think that issue would fall within our purview and i dont know enough about it to make a commitment. I will comment if we look at the avian flu situation or the knowledge of the molecular structure of whatever the pathogen is turns out to be really critical to come up with countermeasures to treat it. I hope we can work out a way and even for food safety, we talk about the imported food, the genetic composition of the pathogen turns out to be important. I get what you are saying, weve got to do this carefully whatever we do but i hope there will be away that we dont get exposed to a new pandemic where we know nothing about the organism. We also most people in america want to maintain their medical sovereignty, the individual medical sovereignty that we all enjoy. Regarding censorship, the cdc was involved in Media Companies taking down social media posts regarding misinformation and disinformation, terms that i think are loosely defined but involved, the fda was involved in this process in the past having awarded several grants in the range of hundreds of thousands of dollars to places like the university of maryland, college park, womens university, regarding misinformation and disinformation. Dr. Robert califf, has the fda coerce social Media Company to take down users social media posts regarding the pandemic or any other topic due to what they described as misinformation or disinformation . Not to my knowledge. Would you consider if the fda is granting organizations like the university of maryland or Texas Womens University to mitigate the spread of misinformation or disinformation, that is essentially subcontracting out that duty, youre saying the fda hasnt done it particularly but have they done it indirectly through surrogates or subcontractors via Grant Programs . Im not aware of the contract you are talking about. Letter member in the entire history of the fda the fda considers data and information, makes a decision about a product, gathers the risks and benefits into a judgment whether it should go on the market, the label is then transmitted to clinicians all over the country who then work with patients to make decisions what to do. The sovereignty were referred to is typically a patientdoctor relationship based on that information. Places Like University of maryland has a major firstrate Medical Center there, intermediaries in this process relaying peaceful information. Someone is saying something thats flatout wrong, how that is dealt with by university of maryland, thats their business. But it also has your approval and when they found out it was wrong in the past, for coercing social Media Companies to take down socalled posts that were later found to be incorrectly done, wheres the remedy . Is there an apology pretty fda that have been fast on the trigger, to change behavior based on things that arent true . Far the it for me to apologize for university. I think with the university does is the universitys business. Is a reflection on the fda. I yield. The chair recognizes representative brown from ohio. Thank you for coming before us today. March 15, 2023, congresswoman presley and i wrote to you urging investigation into the link between chemical hair straighteners and uterine cancer. I was personally like to express my gratitude to the food and Drug Administration for your Rapid Response and dedication to addressing this matter. Im pleased fda has artie take immediate steps with the proposed rule, found in many hair straightening products. Black women experience scrutiny and discover nation regarding our hair which led to widespread use of these products. Black hair should not restrict our ability to advance in the work place, nor should our Hair Products come with health risks. Has the fda finalizes this rule, i look forward to working to ensure Consumer Products remain safe for everyone. I know you are hard at work protecting americans in other ways too. The biden harris admin a station and democrats continue to fight to protect womens reproductive rights. The fdas recent landmark approval of overthecounter Birth Control moves us a step closer to reproductive freedom even amid brutal, backwards, barbaric abortion bands like arizona and other attacks on Reproductive Health including my own state of ohio. Women have the right, women must have the right to control when, if, and how to start a family. Increased access to safe and reliable contraception provides space for that decision to be made while putting control back in the hands of women. So commissioner, what has been the impact so far of overthecounter Birth Control hitting shelves across america . We are in the early phase of it and theres always a lot to work out when something goes commercial but the availability as more manufacturers come on the market, we should see more widescale availability so people can use the product as indicated. One last issue concerns the disease impacting far too many in the black and brown community. Roughly one in 8 black americans live with diabetes. In my district of cuyahoga county, the black diabetes rate is over 25 . Over one in four. Certain fda approved weight loss drugs aid in obesity management for adults with weight related conditions like type number 2 diabetes. For many, these drugs are lifechanging and lifesaving. Unfortunately these medications are often too unaffordable and accessible for those who need them most, especially uninsured individuals. So, dr. Robert califf, hows the da working on these new highly effective treatments reaching populations who need them most . I appreciate your description of the problem, there are special populations at much higher risk, you referred to one. World people in general are suffering greatly. Was one of the main reasons we are seeing this very troublesome decline in Life Expectancy. Right now, despite the fact that we are producing the majority of innovations in medical products, we are almost in last place in high Income Countries in terms of Life Expectancy and its visibility and chronicle diseases that go with it. Unfortunately, our tools and fda specifically are limited for what you describe because we are limited by law in dealing with price of products when they come to market. This is a policy issue for congress to consider. The one thing we do when we have a set of products like this that looks so effective is working with manufacturers to get more products on the market causes complication, does bring the price down but what you are referring to is unfortunate. In many ways, theres a saying that i love, makes you feel bad in a way but it was in the atlantic during the pandemic, Technological Solutions in societys penthouses, diseases our societys cracks. We have a highly effective treatment. She was getting most of it . The wealthy, who needs it most . The people you described who may have lower income and are in the need. This is a major policy problem. The fda limited in what it can do but i can assure you cms is thinking hard about it. I thank you for your thoughtfulness and the work you are doing and look forward to staying in contact with you and i yield the balance of my time. The chair recognizes mr. Palmer from alabama for five minutes. Dr. Robert califf, in your testimony, you said there are safety concerns especially with longterm use, you mentioned a couple things that were problematic including harm to reproductive system exposure particularly concerning children during pregnancy. The fda is engaged in monitoring the use of cbd. Is that correct . s, located because cbd doesnt fall any any particular regulatory scheme. Weve had funding from congress. I appreciate that. My question is should the fda be involved in monitoring cbd . Its becoming popular throughout the country . We would Like Congress to establish a regulatory pathway. An article on National Institute on drug abuse the talks about they ping vaping. I have concerns about the lethality of vapeing. Is that something the fda is engaged in monitoring . To the extent that we can. As we discussed earlier today, regulation of marijuana reaching agreement on regulatory pathway that enables prevention of harm. I agree with you. This body recognize the toback coat industry worked on tobacco and nicotine. The carcinogenic that cause people to get cancer, smoke and tar and other things. From inhaling the smoke. We have the same issues with their marijuana, tar, and other things that are ingested into the lungs but the thing that concerns me about this is this congress acted, i think effectively, dealing with the Tobacco Industry and the 90s. What concerns me now is that we are not doing anything to my knowledge to regulate whats going on in the marijuana industry. In the 1980s as i reminded my colleagues, thc content was 2 . . 17 to 28 , thats the addictive part of marijuana that impacts judgment. What we are starting to see, they get it as oil, and what is happening is more and more children coming in contact with it, and they are found in one of the medical applications in terms of addiction, 90 of them experiment with it. And is that another area the fda needs to engage, its not a dea problem, this is a similar a similar area, Harm Reductions, for what the facts are. For genetic manipulation going way back, and development of mutations, now we have chemical synthesis which can imitate in a highly efficient way to produce the kind of effect you describe the. We are concerned with a regulatory pathway. We need a rulebook, we need to see that in this area. Appreciate your answer and i yield back. We write a lot of rulebooks but have trouble with this administration complying with the rules. Like many of my constituents im deeply concerned with the avian flu outbreak, impacted birds, livestock, one person in orlando last several in the center of the district. It does seem clear the avian flu, and how is the fda in coordination with the department of agriculture and the cdc ensuring americans have access to reliable uptodate information about this . We have noted avian flu has been around a while. And multiple cows and multiple states, and all of government peppered, with multiple efforts, and met lots of areas of government, and we are all working together. As we work through this, remembering this is the most recent episode with the cows is a relatively new thing, we are starting with a lot of uncertainty and working our way through. The federal government stockpiled antivirals, with death from the flu. Will this medication be effective . Its very useful to know that molecular or genetic composition of the virus in this case, closing on it, that should confer. And we feel good about that. And fortunately, only one infected human that we know of so it is not something we can test but looks good at this point. Another subject thats really important to me are allergies. And 20 million americans, to make sure what they are safe. 93 contain an allergen. And popular counter allergy drugs contain lactose. Do you believe they have the power to label prescription and overthecounter food allergens . 3 years ago President Biden signed into law faster act requiring labeling of allergy, and that was submitted. With food and families. Does this fall under the pot responsibly of the fda to provide an update on the status of them. I have to get back with you . Im not familiar with that particular report. Allergies in the us are growing and there is great need to make sure we get this right. We gave a heads up about that question so you could be prepared so we will follow up with it. I yield back. The gentleman yields. Representative mcclain for her five minutes. Dr. Robert califf, you assumed the office of the commissioner of the fda. When you assumed office, and a manufacturer made 40 of the countrys instant recalling all the baby formula it made. It happened the day it was confirmed. Were you aware there was a shortage, an instant formula across the country. It wasnt a shortage but was a shortage of all, that i was aware of. Were you aware that ten states reached rates of 90 of out of stock and nationwide, 74 had no infant baby formula . Those numbers dont sound right to me. What do you think . Would you say we were reaching crisis mode or one or 2 cans . Is closer to crisis. I would like to enter into the record two email exchanges. The officials were discussing the potential, where supply issues asking Media Support to educate the public. The second, february 19th, 2022, fda officials were discussing the supply issue that were already happening. Despite these discussions within the fda, media reports and the president was not aware of the problem. Even though it was headlining in every news channel and every paper across the country for three months. Did the fda not raise concerns about the potential shortage even before the recall . There is a record of supply Disruption Task force put up during the covid crisis used for this purpose. It was elevated . To the task force. Did they raise concerns about a shortage before the recall . I cant speak for before the recall but the time of the recall. The fda did in fact raise the issue to nine different white house official and President Biden took no action. The email between the fda and nine white house staff including members of the National Security council, domestic policy council, to the president for Public Health. Wellknown objections awarded. This email dated february 17, 2022, which was the day of the voluntary recall shows the white house in communication with the fda about the recall. Mr. Chairman, i want to enter another email into the record dated february twentieth 2,022, just three days after the voluntary recall which shows the fda chief of staff already raising concerns of infant formula shortages and communicating this concern with the white house . Without objections awarded. Why did it take three months for President Biden to invoke the defense production act . I cant speak for President Biden, with that particular decision. I dont know the emails you are referring to. I will get them to you in a timely fashion. This evolved over time, the timing of when epa should have been brought in is a matter of discussion. A matter of discussion. Your office has been in communication with nine white house staffers. The fda didnt tell the more he didnt ask. Which is a . I cant comment. You make about 200 grand. You are supposed to be in charge but when you know what hits the fan, it hits the pills. When asking about the handling of this is unbelievable. You dont have an answer. I would love to have an answer but overestimating my salary 190,000. It cost millions of dollars to prepare the products, manufacturers had products at your facilities. And and when do you anticipate, they have been waiting in their Tobacco Products. Almost 27 million applications. One left to go. These are big decisions, they are rolling out, we expect to be caught up with the ones that were largest, Pediatric Group that follows this by the end of this year. I yield time. The chair recognizes representative lee from pennsylvania. Thank you. As we discussed today, the fda has a creek responsibly to ensure our food supply medication and medical products were safe and effective fda doesnt hold this alone. Ensuring the integrity of every product produced by every food, drug and device manufacturer. The private sector plays a Critical Role with the responsibility that they need to take seriously. A pittsburgh based company, one of the largest medical Device Manufacturers in the world receives hundreds of complaints about these machines issuing a recall. The recall end up being one of the largest in history. Not only did the company receive hundred of complaints from hospitals as far back as 2,010, the internal evaluation, indicated they were toxic. They withheld information from the fda for more than a decade. They continue to sell hazardous machines enabling stock prices to the highest levels in decades the most medically vulnerable are infants, seniors, veterans. In pennsylvania there are 700 personal injury lawsuits and class actions due to irreparable harm. The most egregious examples when corporations dont take the responsibility to Public Health seriously. Covid 19 vaccine manufacturing failures to Dangerous Levels in childrens applesauce products, we see the private sector repeatedly fall short. What is the private sectors response ability to ensuring medical devices to the market that are safe and effective . We discussed multiple times the first line response abilities with regulated industry, but we oversee the industry, the industry has the primary responsibility for safe and effective products, whether a device, a drug or food. What investigative action for the fda or does the agency need the whole company for those accountable for a given tory noncompliance to deter future wrongdoing. It would be better for Public Health if we had direct recall capabilities across the spectrum of products when we find problems such as you are referring to. I would like to see bulking up of surveillance capabilities. Every american has an Electronic Health record now and theres a lot we can do so when we find out about these problems but these problems currently are. We need to make sure manufacturers report in a timely fashion when they get the problems they are aware of. To detect dangerous medical devices for realtime status. What progress have they made toward those goals . Theyve been involved in academic life for 30 years, everyone has Electronic Health record and medical transaction digitally captured now and multiple blocks in the system that keep us putting the data as best we can. With voluntary registries, the Companies Pay for it to Health Systems pitch in and the fda find the data. Theres a lot of discussion, other parts of hhs about having better data pooling capabilities so we know about these things in real time and we have a model globally where it is happening in israel where one hundred of the population has realtime Electronic Health record accessibility to detect problems and sometimes there are surprises where something works betterthanexpected, but we dont know about it in real time. I will not get through the next question so i want to respect my colleagues and yield back. Mr. Burchett from tennessee for five minutes. Thank you, appreciate you doing this without a bathroom break. I have a question about the farm bill, 2018 farm bill and the cultivation and transportation products, since 2018, what regulations has the fda put in place regarding the products . We have a law defining hemp as 43 thc. Youve given us money to study the problem as it relates to human health, they are not safe enough to be called a dietary supplement. To a regulatory pathway that will be appropriate so these products are identified and in cases where gummy bears packaged for children, theres a way to take action quickly and that situation. Of outside groups requested the food and Drug Administration regulate products . Yes. Weve had multiple citizens petition. But as i said, the request has been Dietary Supplements and they dont meet the definition of the dietary supplement because of elevated liver enzymes and Health Problems that make them unsafe. They could be regulated another way, made available of congress think thats the right thing to do. Are you an md . Its not in my notes and use our medical things and im curious. I am a boardcertified cardiologist, 35 years of intensive care, mall patient practice. Sadly not practicing right now. You questioned whether we have a heart if youre a cardiologist, is that correct . Lets just say the heart and the brain are two Different Things. Let the record reflect that are commissioner punched, but thank you. I am concerned about him and i will tell you why. Its not in my notes, makes people nervous when i do this, but my daddy fought in the Second World War and i saw videos to help grow hemp to save the world and it doesnt have the thc level. They pass this in the farm bill. We got the greatest thing in the world but i am a United States congressman. It will not make you a fortune but need a fingerprint to do it. It seems to me the big boys from the cotton industry rushing to my office, they wrote these regulations. You and i know it. They dont want the competition. Hemp, you can watch the videos, people say its not the miracle, its a huge labor factor involved in it. It ticks me off that these folks have been fed this bill of goods. It is not happening. Its not happening the way it should. I wonder, i wonder if you had any meetings with the cotton industry officials in which hemp products were mentioned . Im not aware of any meetings like that. It would be an unusual industry for us but not ingesting it. Thats another problem with the product. It goes to two different separate groups. Thats by design, keeps it more complicated. The Biden Administration, the value of hemp production decreased by 71 . Not aware. I will get away from the hemp thing. 30 seconds. That center for Tobacco Products continued to not tell the truth to the American People. They tell us vaporing is more harmful than cigarettes, yet, lets see, nancy regarding of harvard, the professional medical society should reconsider the position on e cigarettes, the burden of tobaccorelated diseases too big for potential solutions such as ecigarette to be ignored. Would you say, i am out of time. It is more harmful than cigarettes if used, if its not abused . Combustible tobacco kills people. I was in the uk, having a regulator, sir richard doll did the study that said died 10 years earlier than the ones who didnt. Vapeing combustible tobacco didnt exist, you wouldnt know what is in the residue from vapeing. If you think of that going into your lungs over the course of decades, its pretty horrifying. But is much less toxic in terms of things that cause cancer and Heart Disease than the combustible tobacco. Thats why the term was used Harm Reduction, they are a lot better off, by those criteria. By using data, no question, no benefit of vapeing other than getting you off of a combustible tobacco. Tobacco is the one product if used as directed will kill you. I went way over. Thank you. The chair recognizes mr. Garcia. Thank you for being here, all your work and the work of the fda. I want to clarify truly insane attacks on vaccines and what we heard earlier today. During the pandemic we lost 1. 3 million american lives, in my city we lost 1300 lives, in california, in long beach, many of the folks we lost would have lived if they had had access to vaccines or been vaccinated. We know the success of vaccines and how effective they have been. What concerning, Early Childhood vaccinations are reaching lows, other diseases coming forward like measles and other diseases. We are now not addressing, because all the vaccine denial that happening not just across this country but also here, in congress, in this chamber. Vaccine hesitancy outside of covid 19 is going to cause this country great harm it. Instead of doing the responsible thing, earlier today we had folks on the other side attack vaccines with, in my opinion, conspiracy theories and treatment of that we know are ineffective that have been shown not to work. Its not just a matter of personal choice. Across the country are millions of people who dont have the choice, they might be too young or immunocompromised or have other underlying conditions. So americas high vaccination rate has helped our country that the fda has been so involved with and it is very concerning that our vaccination rate and process is being attacked. I also want to i also want to note that there have been comments made over and over again about vaccines, about some of vaccines causing turbo carriages or vaccines causing miscarriages or that the cove vaccine somehow has no affect on Healthy People that are all false. And i know that you know this, your team know this, adages want to reiterate that for the public. What i did want to say and have less time to do so but i want to Just Transition and just thank you and your team for what youre doing as relates to listening to the lgbtq community, myself as an openly gay person, i really appreciate the fdas move and decisions allowing particularlyec gay meno be a part of the solution when it comes to health, when it comes to blood donations, when it comes to other forms of surrogacy, the fda has really stepped forward and especially on the recent change in guidelines as relates to the lgbtq americans and gay men being able to donate blood. I think that as a gay person its comforting to know that if the was an emergency where my blood or other blood was needed, that would have that same right. Thanks to all of you. Dr. Califf, in the time i have remaining could you describe the fdas draft proposal now this helps advance equality while expanding the donor pool as relates to the recent changes you guys are all making . Simply parts of all images appreciate your comments, just back on a vaccines, i cant, i just one point i want to make. All medical interventions have risks as well as benefits. In the early discussion that you want to be alive and not be an intensive care unit youre better off getting vaccinated. There are some people that its side effects. I just want to note that because its important to take care of those people also. But the benefits far outweigh the risk. Simply put, the question you asked, people had raised this issue about donation for many years and we did a study which showed a question or about behavior can do much better than just a timebased thing. Related to lgbtq community. We are well along in that now. Looks like a true liquid work and we will be consistent with what other countries are doing. So were really glad were able to come toom this conclusion. Thank you very much for your work and for your teaching. I give expert now recognize mr. Fry from South Carolina. Thank you, mr. Chairman. Commissioner, thank you for being here. Congress enshrined Harm Reduction as a pillar in the 2009 Tobacco Control act. The fdas 2017 2017 straten embraced that Harm Reduction with the former Fda Commission noting successfully, successfully implement Harm Reduction could dwarf the introduction of any new medical technology and its positive impact on a Public Health. Unfortunately, the center for Tobacco Products current leadership under the by administration seems to have abandoned Harm Reduction as the foundational principle of its tobacco policy by refusing to authorize other Tobacco Products data been pending before your agency for years. Your agencys failing to acknowledge the need for real change to t provide better optis for 20 million american smokers. A study from Young Jennifer to found for every. 7 milliliters of ecigarette the liquid that goes unsold due to flavor restrictions and 15 additional cigarettes are sold. It was also about ecigs labor restrictions in place for at least a year yielded 20 increase in sales of cigarette brands disproportional use by underage smokers. Can you expand what the fda and the ctp ofw authorize 900 new cigarettes in the time its it os only a handful of vapor product . First of all, we havent abandoned the principal that you describe but is more complicated in that. Its the responsibility of the company to produce a data set that shows the benefits of smoking, of combustible tobacco reduction exceed the risks due to getting teenagers addicted. Vaping products get people addicted to nicotine if its a new user. Weve always got to balance that risk of getting millions of teenagers addicted to the benefits to adult with combustible tobacco. There are 23 23 parts now ine market that have met that standard and other companies are welcome to submit their data and produce the data showing that they meet that Public Health standard. Does ctp still believe in the continuum of risk of Nicotine Products and as yet you think its helpful for adult smokers who would otherwise continue smoking cigarettes to switch from combustible cigarettes to smoke free alternatives . Yes or no. If not a yes or no answer to that because for adults the best thing to do is to stop using Tobacco Products altogether. The secondbest would be to switch to a vape, but the very best would be as already discussed, if you look at the residue from vaping relative to no use of any tobacco product, it raises a number of issues over the lot. The concern i have the concern many people share is that there seems to be an abandonment of a congressional, not only content, a directive that were going to pursue Harm Reduction as an actual strategy in the country. If you have 900 cigarette that it been approved and only handful of vapor or other products that seems to be divergent to what congress has outlined for your agency would you not agree with that . Are not family with a 900. I would had to go back and look at that but weve not abandoned the idea that the company should show that it can successfully transition people from combustible tobacco to vaping in a way which does not increase the risk to teenagers of getting addicted to nicotine and, therefore, being susceptible to switching to tobacco. In addition to vaping give other products, would you consider that to be a Harm Reduction product . We discussed his earlier. The term Harm Reduction tends to be used by industry to cover a lot of different areas, but if theres a product that can cause someone to stop using combustible tobacco and not get teenagers addicted to nicotine, thats a benefit. There seems to be some reading about the fda, the seems to be some pretty heavy backlog within the agency. How are utilizing your workforce to innovate the fda . What type of metrics are using to make sure you are being productive not only for companies that have products that go beforeuc you, for the American People . As we discussed earlier today i think everyone was surprised by the over 26 million applications they came in. The was a big backlog and weve now clearedhe 99 of that backl. But just like all other parts of fda when applications come they are tracked. We keep track of where we are here and as we are employing Better Technology and we are just going through some organizational changes come youre welcome to read the reagan udall reportedly commissioned to guide w us ther. So were hard at work. We want to meet timelines like we do it all the other product areas and going to the ssas with possibly can. You make a good point there. Thank you commission. Thank you, mr. Chairman. I yield back. Now recognize ms. Pressley for five minutes. Thank you commission for joining us today. Sl first, the let me just also knowledge and thank you for your response this and your swift action, outreach to you regarding formaldehyde and chemical hair relaxers. Also the shortage of childrens tylenol and motrin. Personally as someone living with alopecia to taos i also appreciate your efforts in that regard. And finally for the purposes of my question by today, reproductive justice. Dr. Califf, last year the fda took pivotal steps tort protect medication abortion access, colluding by allowing Abortion Pills to be prescribed by telehealth and distributed by retail pharmacies. Medication abortions accounted for 63 of all abortions performed in the United States last year. If mifepristone is pulled from the market, access to retain medical care would be jeopardized for people across the country. As part off their draconian, unpopular goal for a National Abortion ban, lets call it what that is, forced birth, which for many will result in forced death, republicans continue to try to block Access Communications like mifepristone by spreading baseless conspiracy theories. The fake news is rampant. I have a teenage daughter and we like to play game called two truths and a lie. So youll indulge me were going to variation of that right knee. What used by platform to clarify some of this disinformation by playing a game called fact or fiction. Dr. Califf, ill say a statement in to reply with just one word, stating if it is fact or fiction. Lets start with this. Fact or fiction, the fda conducted a rigorous review of Extensive Research on mifepristone . Correct, that is affected mifepristone is been a market for almost 24 years and more than 100 studies have affirmed its safety sense. Fact or fiction, judges know better than Public Health experts if medication abortion is safe . [inaudible] because the Supreme Court is currently adjudicating a case that impulses. Involves it. But i am on record and so are all of us that it would be bad for entire system of Drug Development and availability of medications in the United States if judges begin overbilling the fda as a matter of routine. Thank you. So thats fiction. The fda, not the courts, determines the safety of drugs. Fact or fiction, mifepristone is a form of, as a from medication abortion is safe and effective . Fact. Correct, that fact. Research shows less than 1 of patients experienced serious side effects, posing fewer risks even then adult or tylenol. The facts are adding up. Mifepristone is a safe, effective, and routine form of healthcare the means necessary and legal across the nation. Now, this may be a game for todays hearing, but unlike republicans i have no interest in playing games with peoples lives, and this is gravely serious. For many, especially black women, pregnancy and childbirth can be lifethreatening. Now, i know this is a shock to the far right extremists old white men making these decisions, but there are hundreds of reasons why someone might want or need to terminate a pregnancy with medication abortion. And policymakers and judges should not be the ones making decisions for them. If republicans and antiabortion extremists have their way, acts as a mifepristone will be cut in every state blue or red, even in my district the massachusetts seventh what abortion care is legally protected. Since a been elected to congress ive been proud to lead the abortion rights and Access Task Force under our prochoice caucus, fighting alongside my colleagues for mifepristone access. Ill continue to fight to form abortion care is a fundamental human right that it is. Andy i urge my colleagues to do the same. Thank you and i yield. The chair now recognizes mr. Burlison from missouri for five minutes. Dr. Califf, in may of 2022 you made an appearance on cnn and claimed that the leading cause of death in the United States is as you quoted, misinformation. Do yousi recall being on that alinterview . You recall making a statement . Okay. Youre right because the claim, he went on to say that in covid that you need to get vaccinated think, quote, somehow reliable truthful messages are not getting across, the wash of a lot of misinformation which is leading people to make bad choices. Now, i do like draw your attention to a tweet that a note you are familiar with. The post says youre not a a horse, youre not a cow. Seriously, yall, stop it. Another sarcastically from the fda red, hold your horses, yall. Ivermectin may be trending but it isnt authorized or approved to treat covid19. The fda put out these messages in 2021 and midsummer post on the other platforms to discourage people from using ivermectin to prevent or treat covid pick agenda 2022 the fda sued, was sued by number of doctors who claim that youre practicing medicine. As an organization. As part of the somewhat you were forced to delete these, is that correct . That correct. So in fact, the u. S. Court of appeals said the fda is not a physician and even tweak e doses of personalized medical advice are beyond your statutory authority. Is that correct . Thats what the court said. Pretended to take ivermectin is dangerous or claiming that it is horse medicine, would you not agree that thats the exact definition of misinformation . I would not agree with that. They are very well done randomized trial showed no benefit of ivermectin. And you knew that in 2021 . I was not at the fda. No, you did know that in 2020 what they get i was not at fda in 2021. Ill ask the questions. Even to this day you have to correct misinformation about ivermectin because you create a narrative that the product which, let me ask you this. Ivermectin has had, it won the nobel prize, did it not . And when the nobel prize for the treatment of worms. Ob in humans. In humans, right . And spit is next to penicillin past and is considered one of the wonder drugs for use and its effectivenesss in humans for correcting spit is a variety of infections that would commonly be known as worms, not for covid. And it is a medicine for animals also. Both are valid uses. Yeah. At the end of the day you created, in my opinion, and i think that its obvious because youre still to this having to correct people who think that a form of treatment that has been used, how may times would you say historically has ivermectin been successfully used in medical treatments . Successful use for warmth but no effective treatment its been administered in humans billions of times over the last 30 years. Again, for the treatment of worms. Dr. Califf, let me askrl thi. Do you think the tweets like this garner credibility to an organization like the fda . Do youo think that snarky twees that i would think my teenage daughters might write, do think that garners credibility with the fda and the American People . I cant really comment on that. Again i wasnt at the fda when the tweet was put out. Well, i would, im glad that the courts told you to remove these tweets because it is snarky. I think its demeaning to the American People and certainly demeaning to people i believe in my district. Thank you, mr. Chairman. I yield the rest of our time. Thank you here come critical to get a quick question here. You mention in a previous question talking about hemp drive cbd oil, that is nonthc or. 3 orr less. You mention you didnt think the fda could ever approve that as a nutraceutical. Is that the fdas position or not . Because there are a lot of people in the industry, in the hemp drive cbd industry that believe that cbd should be treated as a nutraceutical just like supplements and vitamins at gnc and vitamin world and places like that. Your correct. Without a number of citizens petition from people that have had that belief. But the research shows, for example, elevation of liver enzymes which are very concerning that if people take this over time that theres going to be damage to the liver which could lead to things like liver transplants. I have to say this, ive seen this in kentucky with many different cbd manufacturers. Theres a big difference. There is cbd entities because its the wild west because the fda will not regulate this product. There are companies with labs would be as good as anything that mic or Johnson Johnson would have their people operating of the crotch of their house. Ge so the reputable cbd manufacturers in america i believe strongly hope that the fda will come in and not just take samples because these companies are not all the same. You agree with that, right . I would say thatri security e characteristic of every entity that would regulate, and often the good players are penalized because of things that bad players do. Thats one of kauai come back to the referee analogy. Thats were a good referee can be very helpful but the referee needs a a rulebook that says r other rules and you guys write the rules so we would really like it if i plan on trying to play a small role in that moving forward but thank you. The chairto recognizes ms. Crockett from texas 11. Thank you, mr. Chairman. And dr. Califf thank you so much for being here. You are a brave man. I dont know who would want to sign up for your job, especially in a time in which it seems like we dont believe in science, or we dont know what date is only just ignore primarily sure. I dont know how long you were asked about ivermectin, let me tell you something to know if in court but you would be a great witness because you refuse to answer the way that you wanted to do, which wouldve been again putting up misinformation. Because i do want to to do ak level set on something and that of how we continue to come back to this, but let me just ask you a few questions. Was covid19 real . Yes. I had it myself. I think twice, once or twice. Did people die . Just the u. S. Alone over when we people. It was in the top three causes of death for many months. And ie had friends, you know, i was in intensive care unit doctor. When it came to fdai i, but my friends and icus were overwhelmed. Hospitals had to have trucks backing up too the hospital because the wasnt enough room for all the dead people. And did vaccines save lives . Yes. Thank you for asking that again. People that are uptodate on a vexing have a significantly lower risk than being dead or admitted to an intensive care region compared to those who are not uptodate on the vaccine. And worst of all people affected at all, thats true on the individual level. If a look at counties in the u. S. , the counties with a high vaccination rate have lower death rates from covid. If you look at countries use the same general relationship. So the vaccines have beenoo higy effective. Thank you so much. Not perfect but highly effective. I just did. I dontt know that there is any perfection. I know theres none in this chamber. Nevertheless, as a result of administration that believes in science and dated, when you have our age which stands for advanced Research Projects agency for health, and my district likely was recipient of an arbitrator customer service, Customer Experience center. So excited because this means that as well looking at trials come as a look at diversifying them, will have a great opportunity right there in texas 30. It is a Huge Investment in science to make sure we can savn lives, and when the next pandemic arrives, we will actually be prepared to have science so we can stay on top of this because the last time i checked, and doctor, correct me if im wrong, having only suggest that we should inject bleach, are you aware of anyone being cured of covid19 because they injected bleach into their body . I am unaware of any such thing. If i might, in general, and this relates back tosc discussion abt ivermectin. I came along with heart attacks can know when you what caused a heart attack. That was what i focused on. We tried 100 Different Things for the treatment of heart attack. Onlyck a couple of them worked, the others didnt. The only reason we knew it work is we went from the idea to doing it well conducted study, a randomized trial, and then if it worked than all the practitioners began to adopt it and use. So we nowd treat heart attacksy going to the cath lab, opening the some medicines that work. Ivermectin has been studied multiple times in randomized trials. No benefit. But it is highly effective for the treatment of a use the word warms as a generic term for the kinds of infections that typically occur in places like asia that can be devastating. It got an nobel prize because its effective for those, and its been a lifesaver, but its been ineffective in covid. I completelyde understand. The last area that included touchup in my last 45 seconds because i am a woman out of the standard taxes. There was no way im going to have a conversation and that thk about reproductive access to so out of curiosity, would you consider the medical management of the miscarriage to be potentially lifesaving usage . S yes or no. I have to be, i have to declined to answer thatat becaue speed that is perfectly line. Im going to do yes, but im going to give you another question that you can answer. Would you consider erectile dysfunction as a lifesaving usage for viagra . Not lifesaving. Not lifesaving, okay. Well, im going to take that based on my research that mifepristone actually has lifesaving characteristics, yet viagra doesnt pick up for those who dont know, viagra, from my understanding is actually nearly ten times greater as relates to risk of death. Yet, for some reason its not sitting in the court right now. I do appreciate the fact that you laid out that when it comes down to getting drugs approved, the actually go through trials. Its not just randomness. You take the randomness, you did say maybe theres some evidence here and then you put it through the ringer. After putting it through the ringer for decades, womens lives haveyb been saved. And as a representative from the area that roe v. Wade actually initiated, i am appalled because for whatever reason some people want us to go back to horse and buggy in this country. And i think since now maybe we have the s energy, made we shoud take advantage of it and we shouldnt say that we should remain in the times of horse and buggy. With that, thank you for the work that theec fda does. I respect your research. Recognize the courts dont do research. Em i also recognize this chamber seemingly doesnt care about research, but because of the work you do there the ourt are being saved and the need you to be funded to the fullest extent to make sure we can continue to save american lives. Thank you. The chair recognizes mr. Laturner from cancer. Thank you, mr. Chairman. Commissioner thank you for being here. Fda holds responsible for ensuring the safety and integrity of our nations so drugs and Consumer Products. A responsibility that only impacts our economy but also the health and wellbeing of every american citizen. This fda has failed to meet its Mission Statement and is defined by crisis from persistent drug shortages to the most significant disruption to the infant formula marketing history. We cannot afford to overlook these critical failures. The wellbeing of all americans depends on it. Commissioner, i look forward hearing from you today and on how to addresso these pressing issues. Despite the backdrop of food and product safety issues plaguing your organization, fda continues to chase nutrition related policies like front of pack labeling which are arguably outside of fdas purview. Can you explain to the committee what authority you feel fda has to pursue nutrition labeling policy while heavy metals exist in our food supply . Alyssa chinas tobacco product remain accessible, and 263 drugs remain in shortage. We actually had a law that instructs us about Food Labeling thats were adhering to in this case, and i would remind you we have a shortened Life Expectancy in this country, particularly in rural areas thats largely driven by diet and poor nutrition. It seems to become a just some soft pawlenty, seems to be putting information offered of the package is probably like to get useful information so people can make wise choices. That doesnt seem to me like something that should be that hard to get to. If you put on the back, if you like me when you go to the store, youre unlikely to look at. Can you tell me where you drive the authority to do it though . . I have clad to get with your staff and go through the details of that. We believe we do have that athirst i look for to think that. Do you feel it is best if the best of the tax dollars to american eating patterns in lieu of addressing these other Critical Issues . I listed a few pieces of seem like a pretty big deal and you feel like certainly tobacco is a huge one, but i would had to say would look at the fact that we have the lowest Life Expectancy of any high income country, it is being driven by chronic diseases which are being driven by diet. And so to say that we should pay no attention to diet is a mistake. Now, shaping what we are doing is proposing to give people the information they need so that they can make healthy choices and produce these alarming rates of obesity, diabetes. Im a cardiologist, vascular disease. I tell my cardiology colleagues weve got no problem with visit and future in cardiology. I will have limited amount of time. I point to the opec may be as exempt but it appears agencies number of outstanding rulemaking and goals that are not related to food safety. The definition of healthy, symbol for healthy, the dietary guidelines for americans, dietary guidance statement, the list goes on. Can you please tell the committee and consumers all of these pieces fit together . My concern is that not only are you pursuing actions that you do not have the authority for, but you also paying a terribly confusing landscape of rules and advice about what to eat. Well, be happy to work with your staff on going through more detail but in short what we now know about diet its a pattern of eating overtime thats important and how long people live and whether they are burdened by chronic diseases. Its not one specific thing because multiple constituents of the dive when eating regular and the pattern create the kind of Health Problems that are ravaging our country right now. If you like rural areas in particular we are seeing alarming premature death rates thatre are going and the wrong actually for the first time in 50 years. My question, just as it earlier. My question is specific to all of these different initiatives how to Work Together id look for to getting answer on that to match a question. Its been brought to my attention that elicit flavor disposal ecigarettes now make up the majority of the entirety ecigarette market with most of these products are coming from china. Can you speak which agency plans due to rectify the situation . Yes. I mean, we went over the several times already this afternoon but in brief, no one anticipates 27 million applications for vaping products when the door was open for applications. It has been a problem that is quite large and that were gradually making progress in. What are you doing about it . Warning letters, civil money penalties, injunctions and seizures, all of the above. And they hope that will continue to be able to increase our presence out there in a few. Right now we get no user fees from the vaping industry and that money would enable us to put a lot more people in the field to take down these operations that you talking about. It sure feels like warning letters are not getting the job done. Can you walk us to whether and how you personally have communicateded these concerns to doj and custom . Weve had a direct meetings and i have personally gone to several places of importt to met with the Border Patrol and customs people who were there when the stuff comes in. By the way, if you want to get an education on this, go to the International Mail facility speedy what about the doj . Direct persontoperson meetings with doj. I have a key person cell phone number to call an offer our. Im overtime. I just back. The chart of recognizing ms. Tlaib from michigan. Thank you, mr. Chairman. Thank you, commissioner. Were almost done. I am very pleased that you are here. I hadhehe last two weeks a handl of Community Events at fda issued to come up. I want to start with this. How muchho of what fda is doing covering specifically food safety . I mean how much of your resources right now is dedicated to food safety . For detail i would refer you to the reagan udall report that we commissioned last year that has the detailed information. Like 50 . Nowhere near 50 . N although the f in nifty stand for food. On the medicalct products and wh that break because of the user fees but not f on the food asid. Mr. Chair i do want to submit for the record an article, fda food failure. Without objection, so ordere ordered. And i need to talk about this because he comes up a lot. Fda right now has the authorization to regulate water to keep deadly toxin out of produce, right . The water is actually a a mixed. We regulate bottled water the water supply itself is regulate by epaby as just noted. Water on farms as he goes from where cattle may be, for example, that the disputed i want to read from the article. I think its a gorgeous of akron. I know is a couple months meet at you confirmed, quote, by the time if the officials figured out it was spinach those making people sick in ten states can send three people into kidney failure, it was too late. It was mid november 21 and the packaged salad short shelf life and asked if there was no recall provided him fda officials got inspectors on the ground, spanish season was over. The fields in the production facilities were empty, which made it impossible to pin point the source of contamination. What caused causes outbry never fixed. Have we fix this kind of issue a . Again, what was affected because the previous kind of contamination, it is the food, it could be the water thats used, the touches of income used to clean the produce. You know, when you say is a text, why would say is the economist rated the use food safety as tied for first in the world. Look, i work on, get the lead up caucused or my college im a leader on this issue on quality of water. I want to help you. F this is more me trying to show my colleagues and if we really cared about food safety which are missing one of our constituents does use are missing a medication that everybody talks about but they sure attack gather produce, touch the Food Industry in every way. I just want to get to the bottom of what we can you together to ensure you have authorization to oversee Water Quality that touches our food are all right. Were just finalizing now, there are tendrils of food safety modernization, the agriculture waterworld is one that is very pertinent and has to do with what farms should do for example, as the ourct cattle upstream from where the produce is. And so theres a list of things we need. We can be in touch with your staff speedy we leaveve anything out that gives you authority over water, the use of water on produce. Only an reaction to what happens but not after speedy so after contamination. Not for you to. Thats important for us to know and hope the chair and i and others can work on this. The other question i have regarding food, im sorry i know your medical background but food is so incredibly important. Does the fda have authorization to oversee food packaging, right . How about pfas, the use of . What are we doing about the use of packaging around pfas . It relates to the service of food containers and like i was surprise you that we regulate dishwashers when they came in because ofas this. Yes, and its a big so how do we do it . We have studies that sample that a very low rates because the funding is quite low. So we dont really enforce it. Not to ask that we could. Let me just say we are going through as we discussed the largest we organization in history of the fda. Food is the entire focus of i here with some of highest rates of cancer in the world, is that correct . We do. Yeah. I really think we should really prioritize, so well talk about we organization fda, i do hope, we can work all together in a bipartisan way to make sure the food safety is at the center of making sure wee have resources. Again this is me highlighting to my colleagues and educating the American Public we need to do more around food safety. I appreciate that. I do want to point at our new head of the Human Food Program is jim jones who had a career in epa. Hes an expert on the kinds of things thatt you raised, and a y beating up the chemicall for safety part of fda because we had a very small staff historically in that area. I i agree. I think the epa is moving, its low but theyre moving towards trying to again prevent exposure of pfas but the fact that were trying to stop it within water, i can contamination on her five, earth and so forth i think went to aag to b as aggressively coms to our food quality. Last question if i may. I promise this last question to get somebody else another one. Do you believe her are couns expense of vaping epidemic . To the extent epidemic is defined as millions of people, yes. Okay. What do you think we need to as the congress to protect a residence especially our children right now . I know if questioned about it but what do you think we should do . Because making it comes up so much for all of us no matter if a republican or democrat. Well, i think it has to be prioritize. We need more resources. Is it the disposables . When authorizing speech that would be the last question. Feel free to enter that. Thank you, mr. Chairman. The vaping industry doesnt pay use phase and so we have limiteda staff dedicated to thi. We really need to wrap up our staff. That would be the most important thing you could do, and to doing a good job of staying on her case, ill say that. So that needs to continue. Its parts of the process. That you recognize its a cloud from texas for five minutes. Thank you, mr. Chairman and thank you commission for sticking with us through the day. Day. Appreciate giving you pick your agency is responsible for evaluating the safety and effectiveness of medications that millions of americans rely on. Im sure that there are scientists and those working there you themselves as committed public service. I wanted to talk to you about something that you concerning a lot of americans and that it potential conflicts of interest. In 2018 the journal of science found that 11 out of 16 medical examiners who left the fda ended up working for companies they previously were responsible for regulate. Thats roughly twothirds or more than twothirds. These wealthy and powerful pharmaceutical Companies Recruit former fda employees with lucrative job offers in order to leverage their connection. Existing law imposes only a very limited restrictions on this revolving door. Former employees are really prohibited from lobbing pfd for very few specific matters and are subject to a twoyear coolingoff time train. Meanwhile, former fda place can go and collect presubstantial paychecks from companies once regulated. Just commit after leaving the covered service believe medical officer for the fdas office of Vaccine Research and review took a highlevel job at moderna. There was another one recently the medical officer who decide on behalf of the fda whether the Clinical Data moderna sexting medicine met approval standards also took a job shortly after that with the company. Just months after the life, after the vaccine received license. And so i. Think you can see why Many Americans can look at a a history of this and be very, very concerned about whats going on especially coming out of covid, fda along with an number of agencies i think we all look like as if the run a lot of lessons learned, wasnt handled in thens best. Right now we trying to restore the american populace faith in a lot of these institutions that you are now leading and have just taken up the mantle recently with again. Can you speak to the issue with regard to these two at the official specifically, did either of these recuse themselves from any matter at the fda while seeking these jobs that you are aware of . Well, i mean, this last point to make is a very important part of the system, regardless of how you feel about the other parts of people moving from fda to industry or industry and fda. You are prohibited from seeking aa job doctor fink and dr. Testa probably the pronunciation. Whether or not these two recuse themselves of their involvement in these areas wein were leaving after leading for going to murder. Why has the ft refused to provide information . , one unaware of what youre describing. I will circle back applicant that again. If they were not seeking employment while there were n regulating, they did not violate anything. I know that they sought guidance on approval of the fda . Im sorry . The fdas ethics officer for taking those jobs. I would expect that it would have but but i dont know t. Will have to go back. Can you understand the concern and what recommendations would you provide . I think it was 19812019, nine of the ten commissioners went into work forer pharmaceutical companies from leaving their office. You were one of those as well. Im not suggesting any impropriety, but you can surely see i think how this would create a huge concern, a conflict of interest with the American People are looking at this. What recommendations would you suggest that we bring up to make sure that the American People can know that the decisions being made . Because heres the thing. Youre supposed to get oversight to these companies whether youre in food and drug industry. You know youre not going to get a job, not you specifically come by speaking, you do, some of the was one of these highpaying jobs after leaving the department does that the not going to bel hired by someone wo was very strict on them. And so there is a built in incentive of course to be lax in these things. So what can we do and doo provide a level Playing Field that will help restore the Publics Trust in this very. Clad to engage in discussion with you on that but it do want to point out something about this. We are dealing with highly come inside the fte we are dealing with highly technical issues that require a lot of expertise. There are many people who work in industry and then volunteered to come to fda for a much lower salary because they are attracted to thesa issue of understanding the science and making good decisions based on it. Why the same token there are people who work within the fda, they have skills and about an area, and its an issue to say they could never work and industry where there might develop a cure for cancer or whatever the thing may be. So this is a delicate area. He needs to be looked at. Theyre perfectly right to raise im not saying theres no legitimate reason. This why masking your recommendations some who was running the agency right now. What protections can we put, what recommendations would you provide . That would notot be a risk but nine out of ten going straight to the pharmaceutical companies straight out of office is pretty circumspect when American People looking at that. What would you recommend for us as congress that would be reasonable provisions that would allow us to bring the full faith of these agencies back to the United States. With his type is expired please answer the question. I i mean, its a complicated area. I would say number one is just making sure we had here to what said. You raised some questions about this. There are speedy exceptions are given all the time to these is my understanding. So theres rules but would weigh them all the time because its a selfcheck card i dont think thats true at all. I would speak very highly of her ethics office. 26 in the first time around i spent a lot of time bringing in new people, and i dont think exceptions are given all the time to these. But we can always do better and im happy to engage on it. So no recommendations so far . While, its a very broad area summer elected to just offthecuff make a specific recommendations for look forward to working with you. They have called votes for going to try to go to mr. Connolly connelly and then mr. Donalds and then well have these, just two votes. Why not take long. We were recess. I think mr. Moskowitz is ahead of me. We would go to mr. Moskowitz then. Dont worry, touch it. It wont be the usual. Ill try to get some time back. Thank you for coming in commission. Youve establishedou if any of y colleagues get ivermectin, i make it worse, you make sure they get ivermectin. Well have to like rehash all that nonsense. I want to your turned her tension delegate to the aftermath of covid in the pharmaceutical space. Do you think its appropriate that with also supply chain issues that america had during covid that weve not really fixed in a broader sense, but in a medical sense in the form of, pharmaceutical space she was to be getting a majority of her own overthecounter drugs and wuhan . Shouldest to be produced their collection we still be depend on upon wuhan, china, to making drugs that we sell in a significant basis on shelves in this country . While i mean, id say im not sure specifically wuhan, but the key starting matures for drugs are mostly come from china. I dont think thats good for us. We dont need to have no trucks in china, but we need to have a firm Manufacturing Base that we can be confident about in these times of stress. During the two bills, i know you were not necessary debate during the bills come when the Trump Administration one in a Biden Administration are we spent seven or 8 trillion can might at the covid, how come the fda wasnt t advocating, or they were abducted, why within a advocating to start establishing with all that come in money was spent, why were we not establishing we should start manufacturing this product here . I wasnt there at the time. I would you say pretty much the time i came in in february 2022 we really saw how start the problem was and we started advocating then. We live in a country where the pharmaceutical industry is for profit. If people are not getting the prices they want, or the purchaser is getting and or price overseas, thats where the go. So to fix this is going to take some kind of intervention which is well beyond the fda. We are so the advocating that intervention is this. My return your attention, i know you got a bunch of questions on cancer drugs. My dad was diagnosed with democratic cancer. He looked 18 months and ask what about a month i ran for office. He was on desperate the time there were no issues. To think is acceptable in american that families get told by their doctors still connected push off treatment because there is a shortage of a chemotherapy that is helping extending the life, keeping people alive come esto think its example in this country . And why is it that we are not more better, when not better prepared to handle when theres in manufacturing issues with this in india or china. Why are we not better prepared to handle these things . I wont say what is what i was the first of all is taxable. I have a close relative with pancreatic cancer right now. Im not frightening it is. I would just say, whats happened is we have Health Systems, hospitals, pharmacies and whip manufacturers who are mostly overseas now. If we take cisplatin as an example, five years ago it was 400 a dose. Its aa generic drug. I give it as an intern in 1978. Now it was 13 a dose. You cannot make cisplatin for 13 a dose and maintain quality. Some people running the Companies Say why should i make it well have a system in place this as this is an essential drug. Were going to put something into effect which causes the market to behave. I dont want to interrupt. You are the fda. Perhaps that something you guys should be looking at. I mean, there are also swasey working with manufacturers all day long on trying to incentivize them to make lifesaving drugs that may not if i may, with no authority to give incentives. We are prohibited by law from dealing with pricing. But i would refer you to the hhs report that came out last week with a heavy input the ghost of all the details here. Im completely in tune with your concern, editing people around the administration know every time im on a call i bring it up. Theres been reported some of the vaping products in florida singh fentanyl in them. What are we doing about some of these things come in from china, some of these illegal vaping product . This is, very concerned about what you raise. We just had a meeting, annual beating atlanta were mostly parents of children have died from overdose. The administrator was and gave the details about how these products are getting into the mainstream of america through cartels. Predominately. This is really a combined effort of the but is now become a Law Enforcement issueue with dea, ad were working together as closely as we can. But im not pretending we have this problem solved. It is a big desperate thanks commissioner. The chair now recognizes mr. Donalds from florida. Thank you, chairman. Commissioner, thanks for being a very i support the fdas efforts to reduce Youth Smoking rates under the Current Authority granted by congress however, i do not support the unnecessary and then other regulations like the fdas proposed tobacco product standard for characterizing flavors in cigars rule which is purely based on frankly my view on more politics and science. What are some of the examples of the unattended consequences that might arise out of this rule . Well, first, the intended consequences would be a reduction in death rates, which is pretty important one, in my view. In terms of unintended consequences, there is always going to be some illicit market when rules like this are put into effect. So then to think its wise for the fda to proceed . I think its very wise to reduce the death rates, but speed is commissioner, you acknowledge were seeing a trend a lotma of markets associated wh smoking. But right now we focus on flavored cigars. T so is your contention is it is okay to put in this rollaround flavors in premium cigars because you have told you are choosing to smoke flavored premium sigar. If you want to talk about flavored cigars, i would you say you right now are Smoking Cigars and their smoking cigarettes. Flavored cigars are highly attractive to youth. Its as. Major concern that we have. Premium cigars is a different issue. Thats in the court try to so i cant comment on it. Secondarily, california not get a flavor been little tobacco product of the 2022. California suffers from the second highest rate of cigarette smuggling where nearly 50 of all cigarettes use by consumers are purchased outofstate. Further in 2021 sigrid paxton come for smuggled from international markets. In which way does illicit Tobacco Market impact the United States of america . I just was out in california about four months ago i met with the Public Health department there. Their longevity is so much higher than the average of the United States, largely due to reduction in things like use of tobacco. I have very low rates of the use of tobacco compared to the rest of the u. S. Overall it is a net positive. Are we going to note the fact that yes, there a black market propping up whether its illicit cigarettes or if we are going to go back to the previous topic of premium cigars . In part because of the policies of the United States . Do we acknowledge that . As ive discussed on the cardiologist on use to life and death. Almost everyone prefers to be a lot. I would rather reduce total mortality and deal with the illicit market than to tolerate 460,000 americans dying of tobaccorelated illness00 or yor which is what our current rate is, thats lower from what it used to be. By commissioneratto we also mr. Commissioner, we also have to acknowledge the fact that youre not you can control the actions of people. Do you truly believe you have the ability control the actions of americans if they choose, adults now, away from children from overtime adults if they choose to smoke s a sigar or thy choose to smoke a sigar . I dont agree with smoking cigarettes. Not a secret smoker but at the same time do we acknowledge the reality when you put of these barriers which also do is great and illicit market for these products which could be more harmful toet the users that use them . I would never pretend to be able to control the people people. Imagine if we taken that attitude when i started out as a cardiologist average patient to care for was 50, to put a man, dying at a rate of 30 out of every 100 people with heart attack in the first 30 days. Now the typical patient with Heart Disease is in the 70s because the rates of use of tobacco drop so much. Not because someone the think thats because informing the public weca thinks because the government regulation . I think its a combination both of those. I would argue its far better to get people to change behavior by informing them of the consequences of said behavior as opposed to putting up arbitrary rules from fd or anywhere else. I like that in general but this is a highly speeded not general. That is reality of the human condition. When you deal with people suffering from addiction, nicotine is a terrible addiction, very difficult to be speeded we are talking about fda rules around frankly flavored cigars and also some of the california nicotine azide addictive substance. We are talking speed im well aware that it is, but again i would argue that information and education is far better than regulation and elimination. I yield. The time of the gentleman has expired it. Pursuant to the previous order the committee stands in recess subject to the call of the chair. The committee will reconvene for ten minutes after votes. Stand in recess