Transcripts For CSPAN3 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. E what kids are bringing togs, i 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 the legal imports that include inspections beyond the biological and chemical realm. According to september 2017s report, titled imported seafood safety, the fda and usda could strengthen efforts to persuade, to prevent unsaved drug residues in imported seafood. A whistleblower has come forward indicating that a Company Called choice tanning, in it shrimp exporter has knowingly exported contaminated shrimp to the United States, despite this, fda data shows that only 21 shrimp samples from this company have been tested since 2003. Just to put this in perspective. Again, respectfully, you have a massive job to do and limited resources. This company that im referencing is a known violator, imported 24 Million Pounds of shrimp to the United States last year alone. So basically, imported seafood is coming into our country, in billions and billions of pounds. It is being actually inspected at the Laboratory Level for biological and chemical contaminants. And the reason we are not getting sick is because we cook the seafood. Thats a reality. I would like to ask you, if you had add legislation from this body that gave you peak in your enforcement, like the mechanisms to destroy shipments that had been found to be contaminated, with that power be helpful for fda enforcement of imported seafood that violates american standards for biological and chemical contaminants . Dr. Califf you asked the question in up specific way that im reluctant to say just yes. What i would say in the general direction you are going, i would say in general, including this arena, the industry is the ability to do a you describe. Its not just in the area that you mention. But in general, i believe we would exercise our authorities responsibly and could more quickly take care. There is stuff, which sits there for a long time, given all the things we have to do in order to stop. My intention and thank you, im going to close by saying that my intention is to legislatively empower the fda to have their aggressive responses to shipments of contaminated seafood that enters our country. Mr. Chairman, i yield. Dr. Califf im a south carolinian, i think our shrimp is better than yours. Theres nothing i like better than to see a resurgence of the seafood industry. Ive learned from a young man not to argue with a gentleman in a bowtie, so i will let you have that. The chair recognizes new mexico. Thank you, mr. Chairman and thank you dr. For being here. Its wonderful to have you. I want to thank your staff are being here and im grateful for the opportunity to highlight the importance of science and sciencebased decisionmaking in this hearing and all that you are doing to protect the American People to ensure that we have access to medicines that work, that we have food that doesnt harm us, and to ensure that every american can get lifesaving care. Also for your work in the administration, support of our work that has allowed congress to pass legislation to expand access to health care, to invest in science and innovation, and to expand access to Prescription Drugs for seniors. The fda is truly on the front lines of that battle every single day and we are really grateful for the work that you do. I will say on a personal note, i have a Family Member who was formerly an fda employee and you represent the best of the best that 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 we have seen republicans in this body, in fact in this room and across the country have been working to ban abortion, first or Donald Trumps Supreme Court, which overturned roe v. Wade last summer, then chipping away statebystate to implement abortion bands, including where, in arizona, just this week a civil war era abortion ban was upheld. For folks that dont know, this band was put in place in 1864, before an end to slavery had been ratified by this body. Before women could vote in before arizona was even a state. Lets be clear, no judge, no politician, no person should be able to tell a woman, any woman in america or anywhere in the world which she can do with her own body. And nowhere is 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 since the last couple of years over mifepristone. I want to ask you a question, if you could talk to us a little bit, not only about the implications of the decision by the Supreme Court, which we expect for women to access reproductive care through medicated abortions, but what are the wider implications for fdas ability to use science to approve medicine . Dr. Califf thank you for the question, since this case is under consideration of our Supreme Court, im very limited on what i could say. I will say that we stand by our decisions, we are still in place 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 myth oprah stone mifepristone to be used in a medicated way of addressing issues around reproductive care. The broader implications are that if judges start legislating from the bench on this kind of medicine, could be anything, it could be cancer treatments, it could be any kind of medication or intervention in your health. I think the American People need to understand the implications of this case, the potential impacts for Public Health and the ability for it to impact every americans opportunity to access lifesaving care. So we appreciate your work, and i am personally thankful to be from a state, from new mexico, that has worked to protect reproductive care. If the Supreme Court does overturned the 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. That is why this body has to urgently take action, thats why we have to defend the signs, thats why we have to sit here and defend our agencies who are making sure that american women that all people have access to the care that they need, and thats by we have to do everything we can to defend our institutions because the lives of our community literally depends on it. Quakes everywhere i go in the world, our system of Drug Development and decisionmaking is the envy of the rest of the world, they all want to be like that just feel like as. Our use of generic drugs in Public Health is falling short with our drop in Life Expectancy. But the system that you described this one that is very important that we preserve, in addition to the topic you are talking about. The chair now recognizes mr. Perry from pennsylvania. Thank you mr. Chairman, thank you doctor. I want to talk to you about the world health organization. My name is called all kinds of things. Im sorry. Dr. Califf ive had a lot of different pronunciations. That was in an incorrect pronunciation, that was just plain damn wrong. I want to talk about this treaty. Maybe 85 plus nations including yemen, iran, afghanistan, cuba, haiti, and some terms and that, we havent seen it. We havent seen the 30 plus amendments, so we are shooting in the dark. I dont know that you know any more than any of the rest of it about it then we do, but there was another draft just last month that created a multilateral system for sharing pathogens with pandemic potential. I already listed some of the countries involved, it also commits each party, which would include us, if we were signatories, to promote timely access to evidencebased information for the pandemic. In the aim is to combat misinformation and disinformation, i guess, as you see it or as they see it. My question is, with the potential threat to u. S. Sovereignty, for decisionmaking on whether a pandemic even exists and the prescribed remedies, including law downs and maybe even medicaid, which you commit before the committee today to pledge not to adopt policies included or pursuant to the treaty until such time, and if such time if that treaty would be ratified to the United States senate . Dr. Califf im not sure how to answer that question, given the complexity of what you said. Its hard for me to imagine that we would do something fee fda said is not a government policy. Im just not familiar enough. It would not be a treaty that we would be signatories to or at least not legally. I just want to know if theres any intention on the fdas part to institute any of the provisions within the treaty without the proper ratification from the United States senate . Dr. Califf i dont think that particular issue would fall within our purview and i dont know enough about it to make a commitment. I will, that if we look at the avian flu situation we are in now, the knowledge of molecular structure of whatever the pathogen is turned out to be really critical to come up with countermeasures to treat it. So, i hope we can work out a way. Even for food safety. We talk about the imported food that we get, the genetic composition of the pathogen turns out to be really important. I get what you are saying, we have 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 until its too late. 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 immediate Companies Taking down social media posts regarding misinformation and disinformation in terms that i think very loosely defined. But the fda has been 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 and college park, Texas Womens University. Regarding misinformation and disinformation. Commissioner, has the fda forced social Media Company to take down social media posts regarding the pandemic or any other topic due to what they described as miss or disinformation . Dr. Califf not to my knowledge. Would you consider if you are paying, if the fdas granting organizations like the university of maryland or Texas Womens University to mitigate the spread of misinformation or disinformation, thats essentially subcontracting out. You are saying the fda has not done a particularly, but have they done it indirectly through surrogates or subcontractors through the grant project . Dr. Califf im not aware of the particular project you are talking about. Throughout the history of the fda, they consider data and information, makes a decision about a product, puts together the risks and benefits as to a judgment as to whether it should go on the market. The label is then transmitted to clinicians all over the country who then work with their patients to make decisions about what to do to sovereignty. What you referred to is typically a teacher, doctor relationship. Harsh Light University of maryland has a first grade medical center. Maybe its a process of relaying useful information. If someone is saying something that is flat out wrong, how thats dealt with by the university of maryland, thats their business. But it also has the improve and of your approval. When they found out they were wrong in the past from coercing social Media Companies to take down socalled posts that they were later found to be incorrectly done, where is the remedy and is there an apology from the fda, and admonishment to the fda from these universities that have been fast on the trigger and coerced and changed the narrative or change behavior based on things that arent true . Dr. Califf its hard for me to apologize for university. Im my Longtime University person. With the university does is what they do. It all shows a reflection on the fda. The chair now records recognizes representative brown from ohio. Thank you commissioner for coming before us today. On march 16, 2023, congresswoman presley and i wrote to you urging an investigation into the link between chemical hair straighteners and uterine cancer. I would like to express my gratitude to the food and Drug Administration for your Rapid Response and dedication to addressing this matter. I am pleased they have already taken immediate steps with the proposed rule to limit the use of harmful chemicals found in many here straining product. As you know, black women experience scrutiny and discrimination regarding our hair, which has led to widespread use of these products. Black hair should not restrict our ability to learn in school or advance in the workplace. Nor should our hair Care Products come with health risks. As the fda finalizes this rule, i look forward to working together to ensure our Consumer Products remain safe for everyone. Furthermore, i know youre hard at work to protect americans in other ways. The Biden Harris Administration and democrats continue to fight to protect the preserve womens reproductive rights. The fdas landmark approval of overthecounter birthcontrol moved us one step closer to reproductive freedom, even amid little backward and barbaric abortion bands like arizona and other attacks in 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. Commissioner, what have been the impacts so far of over the counter Birth Control hitting shelves across america . Dr. Califf we are in the early phases of it, obviously, and there is a lot to work out when something goes commercially. The availability as more manufacturers come on the market given the precedent, we should see more widescale availability and people can use the products as indicated. Ms. Brown one last issue is a disease affecting many in the black and brown community. Roughly one in eight black americans live with diabetes while in my district, the diabetes rate is over 25 . Over 1 in four. Certain fda approved weight loss drugs help with obesity, and the underlying conditions, like type 2 diabetes. For many, these drugs are life changing and lifesaving. Unfortunately, though, these medications are often too unaffordable and inaccessible for those who need them most, especially uninsured individuals. Commissioner, how is the d. A. To make sure the new highly affected treatments are reaching populations who need it the most . Dr. Califf first of all, i appreciate your description of the problem. There are special populations at much higher risk. You referred to one. I would say rural people in general also suffered greatly. And one of the main reasons we are seeing this troublesome decline in Life Expectancy. Right now, despite the fact we are producing a majority of the innovations in medical products, we are almost in last place in high Income Countries in terms of Life Expectancy and the disability and multiple chronic diseases that go along with it. Our tools at fda are limited for what you described because we are limited by law in dealing with price or products when they come to market. This is a policy issue for all of the administration and for congress to consider. The one thing we do when we have a set of products like this that look so effective so far is working with the manufacturer to get more products on the market because the competition does bring the price down. What you are referring to is most unfortunate. There is a saying that it makes you feel bad in a way. But it was in the atlantic during the pandemic and technological solutions. Technological solutions drift into societies penthouses. Diseases seep into societies cracks. And the problem is, here we have an effective treatment, who is getting it. The wealthy. Who needs it the most, the people you described who may have lower income and are in the need. So this is a major policy problem. Im sorry the fda is limited in what it can do but i can ensure that thinking hard about what it might do for this. Ms. Brown i thank you for your thoughtfulness and i thank you for the work you are doing and i look forward to staying in good contact with you. With that, i yield the balance of my time. Mr. Comer the chair recognizes mr. Palmer from alabama for five minutes. Mr. Palmer you said use of cbd raises safety concerns, especially longterm use and mentioned a couple of things that were problematic including harmful male reproductive system exposure and concern for children during pregnancy. The fda is engaged in monitoring the use of cbd, is that correct . Dr. Califf its a little complicated because cbd does not fall directly under any particular regulatory scheme we have. We have had plenty from congress to study the problem from independent studies mr. Palmer i appreciate that, my question is should the fda be more involved in monitoring cbd . Because it is becoming extremely popular throughout the country. Dr. Califf we would very much Like Congress to establish a regulatory process for cbd. Mr. Palmer we talked about vaping and not going to get into that but i have Major Concerns of the products coming from china and i have concerns about the lethalitiy whether it is tobacco or marijuana and is that something that the fda is actively engaged in in monitoring . Dr. Califf to the extent that we can. As we discussed earlier today, the regulation of marijuana is another area where we would benefit from congress reaching agreement on a regulatory pathway that enables the prevention of harm being done. Mr. Palmer im glad you brought that up, because i agree with you. This body in the 1990s recognized that nicotine is not the carcinogenic that causes people to get lung cancer. It is the smoke and other things caused from inhaling the smoke. You have some of the same issues with marijuana. That theres tar and other things that are ingested into the lungs. The thing that concerns me about this as well, and this congress acted i think effectively in dealing with the Tobacco Industry in the 1990s but what concerns me now is that we are not doing anything to my knowledge to regulate what is going on in the marijuana industry, particularly in the genetically modified products. In the 1960s, 70s, 80s, thc content was about 2 . Now it is anywhere from 17 to 28 . And thats the addictive part of marijuana that affects the frontal lobe and impacts judgment. What we are starting to see now again, it comes in different forms. You just dont smoke it but take it as a gummy, or as an oil. And what is happening, more and more children are coming in contact with it and there is a report from the National Center for biotechnology and information that is found one of found in one of the medical publications that says in terms of addiction, 9 of those people who experiment with it become a become addicted. 17 of those are teenagers. Is that another area where the fda needs to engage because we see more and more states legalizing this. It is not a dea problem, it is a consumer problem. Dr. Califf i believe this is a similar area where Harm Reduction through a regulatory strategy is our best approach and we need more research on what the facts are. Remember that the Tobacco Industry was engaging in genetic manipulation going way back just through the medallion radiation of the plant and development of mutations that would lead to more and more nicotine in the product. Now we have chemical synthesis that can imitate almost any of these in a highly efficient way to produce the effects you described. Increased addiction. Dr. Califf so we are concerned and would like to see a regulatory pathway and we talked about we need a rule book and you guys write the rule book. We would like to see a rule book in this area. Mr. Palmer i appreciate your answers and i yield back. Mr. Comer we write a lot of rural books and we have trouble with this administration complying with the rulebook. They march to their own drummer. But anyway, the chair recognizes mr. Frost from florida for five minutes. Mr. Frost im deeply concerned with the h1n1 avian flu impact. It impacted birds, livestock, and one person. It killed some of our lake eola swans, the symbol of our city. While it does seem clear that the avian flu is not currently able to spread easily among people, folks are wondering how safe they are. It is brought up a lot in my district. Commissioner, how is the fda in coordination with the department of agriculture and cdc ensuring that americans have access to reliable information regarding this . Dr. Califf thank you for bringing this up. It is an important information. Avian flu has been around for a while but only recently it has now infected cattle and cattle cows in multiple states. This is an all of government effort. There are zoom conferencees multiple times a day now involving fda, cdc, agriculture, and many other areas of government that have a stake in the game of interstate commerce and department of justice and issues that are related. So we are all working together. You should see frequent communications as we work through this. Remembering that this is the most recent episodes with the cows is a relatively new thing. We are starting with uncertainty and working our way through it. Mr. Frost since 2006, the federal government stockpiled antivirals designed to prevent and severe illness and death from the flu. Will this medication be effective against avian . Dr. Califf this relates to a discussion we just had. It is useful to know the genetic composition of the virus. In this case, if you look at the composition of this virus, there is nothing in it that should confer resistance to the current antivirals we have stockpiled. We feel good about that. I should note it is always the case where when you have an actual illness you have to , emperically prove that it works. So fortunately right now, there is only one infected human that we know of. So it is not something we can test, but it looks good at this point. Mr. Frost thank you you, i appreciate it. Another subject that is important to me are allergies. I am a survivor of anaphylactic shock a few years ago that almost killed me. I also want to make sure the other 20 million americans with Food Allergies know that what they are taking is safe. A recent study showed 93 of all food contains allergens and many contain lactose. Does the fda have the power to require labeling for prescription and overthecounter medicines for food allergens and dpleuten . Dr. Califf we have the power to require labeling when it is indicated. Mr. Frost biden signed into law the faster act requiring labeling of sesame as a food allergy and hhs to submit a government report on Food Allergies. That report has not yet been submitted and it is very frustrating to people with Food Allergies and their families. Does the report fall under the responsibility of the fda and would you provide an update on the status of it . Dr. Califf i will have to get back with you on that. Im not familiar with that particular report. But we are very familiar with the fact that allergies in the u. S. Are apparently growing and there is a great need to make sure we get this right. Mr. Frost we would love to follow up on that. I think we even gave you a heads up about that question so you could be prepared, but that is all right. I yield back. Mr. Comer the gentleman yields. The chair recognizes the gentlelady from michigan, representative mcclain for her five minutes of questions. Mrs. Mcclain when you assumed office of commissioner of fda in february 2022, correct . When you assumed office were you , aware that a manufacturer who made more than 40 of the countrys infant formula was voluntary recalling all the baby formula it made at its plant . Dr. Califf i was very familiar. It happened on the day i was confirmed. I didnt ms. Mclean i will take that as a yes. In the days and weeks that came after you assumed office, were you aware that there was a shortage of infant formula across the country . Dr. Califf in the first days and weeks, there was not a shortage. But i was aware of. Ms. Mcclain were you aware 10 states reached 90 of out of stock and nationwide 74 had no infant baby formula . Dr. Califf those numbers do not sound right to me but there was a lot of out of stock. Ms. Mcclain could you say we were reaching crisis mode . Where were we sure one or two cans . Dr. Califf closer to crisis. Ms. Mcclain i would like to enter two internal exchanges within the fda. The first one is february 4, 2022 where they are discussing the potential of infant supply issues and asking support from the white house to educate the public. The second on february 19, 2022 in which the fda officials were discussing the supply issue that were already happening. Now despite these discussions within the fda, media reports and the president was not aware of the problem. Even though it was headlining in nearly every news channel and every paper across the country for three months. My question is, did the fda not raise concerns about the potential shortage even before the recall . Dr. Califf as you know, there is a record of this. There is a supply Disruption Task force that was put up during the covid crisis that was used for this purpose. Ms. Mcclain it was elevated . Dr. Califf to the task force. Which has ms. Mcclain did the fda raise concerns about a potential shortage even before the recall, yes or no . Dr. Califf i cannot speak for before the recall, but about the time of the recall. Ms. Mcclain the fda did, in fact, raise the issue to at least nine different white house officials and President Biden took no action. So i would like to enter an email between the fda and nine white house staff including members of the National Security council, Domestic Policy Council and special assistant to the president for Public Health. Without objection, so ordered. Ms. Mclean thank you. This email dated february 17 of 2022 which is the day of the voluntary recall shows the white house in communication with the fda about the voluntary retail. Mr. Chairman, i would like to enter another email into the record, email dated february 20 of 2022 just three days after the voluntary recall which shows the fda chief of staff already raising concerns about an infant formula shortage and raising concerns with the white house. Chair comer without objection, so ordered. Ms. Mclean commissioner why did , it take three months for President Biden to invoke the defense protection act . Dr. Califf i cant speak for President Biden in that decision. I will note as i have already said, i dont have emails that you are referring to. Ms. Mcclain ill get them to you in a timely fashion. Dr. Califf this evolved over time so the exact timing of when the dpa should have been brought in in is a matter of discussion. Ms. Mcclain thats your answer. A matter of discussion. Your office has been in communication with nine white house staffers, either the fda didnt tell him or he didnt act, which is it . Dr. Califf you have the email. I cannot commit be on that. Ms. Mcclain you make about 200 grand and you are supposed to be in charge. But when you know what hits the fan, everybody runs for the hills. Its my time. When asking about the handling of this, it is unbelievable. You dont have an answer. I would love to have an answer. Dr. Califf you are overestimating my salary. Ms. Mcclain 191,000. It cost millions of dollars to prepare premarket Tobacco Products. Manufacturers have had products pending at your facilities for years. I know we have talked about this and you know the concern of the illegal products coming over from china. When do you anticipate getting some results from these American Companies that have been waiting for over four years on their Tobacco Products . Dr. Califf as we have already discussed, we are 99 done with almost 27 million applications. We have 1 left to go. These are Big Decisions and going to be rolling out. We expect to be caught up with the largest from the American Pediatric Group that follows this by the end of this year. Ms. Mcclain i yield time. Mr. Comer the chair recognizes representative lee from pennsylvania. Ms. Lee the fda has a critical responsibility to ensure that our food and medicine is safe and effective but the fda does not hold this responsibility alone. The agency does not have the resources to single handedly ensure the integrity of every product of every food and device manufacturer. The private sector also has a Critical Role in ensuring their products are safe and they need to take responsibility. Recent reporting has covered a pittsburgh based company and one prior to issuing a recall in 2021 that ended up being one of the largest in history. The Company Received hundreds of complaints from hospitals, patients and providers but its internal evaluations indicated their machines were toxic and yet the company withheld the information from the fda and public for more than a decade. They continued to sell these hazardous machines and enabling their stock prices to soar and the most medically vulnerable in our communities, infants, seniors, veterans, suffer. In pennsylvania there are more than 700 personal injury lawsuits and classaction lawsuits against the company due to irreparable harm its devices caused patients. One of the most egregious examples. Covid vaccines to Dangerous Levels of lead in childrens applesauce we have seen the private sector repeatedly fall short. What is the private sectors responsibility in ensuring that medical devices brought to the market are safe and effective . Dr. Califf as we have discussed multiple times today the primary , firstline responsibility is with the regulatory regulated industry. We oversee the industry but the industry has the responsibility to produce safe and products whether device, drug or food. Ms. Lee what enforcement action does the fda have or need to hold Companies Like that accountable and deter future wrongdoings . Dr. Califf this has come up in almost every commodity now. It would be better for Public Health if we had direct recall capabilities across the spectrum of products that we regulate when we find problems such as youre referring to. I would also like to see a building up of our postmarket surveillance capabilities. Every american has an Electronic Health record now and there is a lot we can do so that when we find about the problems earlier than we currently are, we need to make sure the manufacturers report in a timely fashion when they get problems they are aware of. Ms. Lee over the years, fda has promised to overhaul the way it detects dangerous medical devices. What progress has fda made towards those goals . Dr. Califf this has worked in my academic life for 30 years. If you think about it everyone , has an Electronic Health record and every medical transaction is digitally captured now. We have multiple blocks in the system that keep us putting the data down as best we can. We are dependent on voluntary registries where Companies Pay for it or Health Systems pitch in and then the fda gets the data. I am pleased to say there is a lot of discussion with nh nih and other parts of hhs and about having better pooling capabilities so we know about these things in real time. And we have a model where it is happening in israel where 100 of the population has realtime Electronic Health record accessibility to detect problems but also to find advantages. Sometimes there are surprises where something works better than expected. But right now we dont know about it in realtime. Ms. Brown i am not going to get through this next question and i want to respect everyones time and yield back. Mr. Comer the chair recognizes mr. Burchett from tennessee for five minutes. Mr. Burchett i appreciate you doing this without a bathroom break. Shows great admiration. I have a question about the farm bill. 2018 farm bill and it is about the cultivation sell and transportation of hemp derived products. Since 2018, what regulations have the fda put in place regarding hemp derived products . Dr. Califf we have a law from you defining hemp as less than. 3 thc. You have given us money to study the problem. As our conclusion as it relates to human health is they are not safe enough to be called a dietary supplement or food so we asked congress to put together a regulatory pathway that will be appropriate to the products are available but they are labeled and identified and in cases of gumming bears gummy bears package for children there is a way for us to take action quickly about the situation. Mr. Burchett have any outside groups request the fda regulate hemp derived products . Dr. Califf yes. Multiple citizen petitions. The requests have been to regulate them as Dietary Supplements and they do not meet that definition because of elevated liver enzymes and other Health Problems that we believe make them unsafe as supplements. But they could be regulated in other ways and made available if congress thinks that is the right thing to do. Mr. Burchett are you an m. D. . You were saying some medical things. Dr. Califf i am a Board Certified cardiologist. 35 years of practicing, sadly not practicing right now. Mr. Burchett you would question whether we have a heart if you are a cardiologist. Is that correct . Dr. Califf lets just say the heart in the brain are two Different Things. [laughter] mr. Burchett let the record reflect that our commissioner is punchdrunk from being up here so long. Thank you. I am concerned about hemp. And ill tell you why. It always makes people nervous when i go off my notes. But hemp, my daddy fought in the second world war. And they made rope out of hemp. Its like marijuana but without the thc level and then they come down here and here is the farm bill and these folks that want to grow hemp, they say we have the greatest thing in the world. But im a u. S. Congressman and i have a little farm. I checked into growing hemp. Not going to make me a fortune but i have to get a fingerprint to do it. The big boys from the cotton industry will be marching up to my office, but they wrote these regulations. They do not want the competition. They dont want hemp. And you can watch the videos, these people say its not the miracle they claim it is. Because there is a huge labor factor involved in it and it really ticks me off that these folks have been fed this bill of goods and its just not happening. Its not happening like it showed, and i am wondering if you or anyone in your office have had any meetings with the cotton officials in which hemp was mentioned . Dr. Califf i am not aware of any meetings with the cotton industry. It would be an unusual industry for us to meet with. Mr. Burchett besides the fact not ingesting it. Thats another problem with the product. It goes to separate groups. I think that is by design. So it keeps it more complicated. Are you aware in the first two years of the Biden Administration that the value of hemp production in the United States decreased by 71 . Dr. Califf no. I was not aware. Mr. Burchett ill get away from the hemp thing. I have 30 seconds. The center for Tobacco Products , i feel like theyve continued to not tell the truth in some cases to the American People. They tell us vaping is more harmful than cigarettes, yet dr. Nancy regarding of harvard should reconsider precautions position on ecigarettes for quitting smoking. The burden of tobaccorelated diseases is too big for ecigarettes to be ignored. You get where im going. Is it more harmful than cigarettes, if it is not abused . Dr. Califf here is what i would say. Combustible tobacco kills people. I was in the u. K. Because we are having a regulator. I went to oxford where the british doctor study, doctors who smoked died 10 years earlier than those who didnt. Vaping, if combustible tobacco did not exist you would be , harmed in the residue whats in vaping. And thinking of what is going into your lungs over the course of decades it is pretty , horrifying. But its much less toxic in terms of all the things that cause cancer and Heart Disease. The vaping than the combustible tobacco. Thats why the term Harm Reduction is used. If you have someone using combustible tobacco, they are a lot better off if they are vaping, at least by those criteria. But compared to using neither there is no question, there is , no benefit of vaping other than if it helps you get off the combustible product. Mr. Burchett tobacco is the one product that, if used as directed, will kill you. I went way over. Thank you, guys. Mr. Comer the chair recognizes mr. Garcia for five minutes. Mr. Garcia i appreciate you being here and all of your work and all of the work of the fda. I was going to talk about a different topic but i want to clarify some of the truly insane attacks on vaccines and just what happened during the pandemic that we heard earlier today which i found to be really wild. During the pandemic we lost 1. 3 , million american lives. In my city, we lost 1300 lives in the city of long beach. We know that many of the folks we lost would have lived if they had access to the vaccine. Or had been vaccinated. We know that for a fact. We know the success of vaccines and how effective they have been. What is concerning is that Early Childhood vaccinations are reaching lowes and other diseases are coming forward like measles and that we are now not addressing because of all of this vaccine denial is happening not only across the country but here in congress, in this chamber. Vaccines outside of what happened in covid19 is going to cause this country great harm. And instead of doing the responsible thing, earlier today we folks on the other side attack vaccines with in my opinion, conspiracy theories and with treatment that are ineffective and have been shown not to work. This isnt a matter of personal choice. There were millions across the country who do not have the choice. They cannot get vaccinated because they might be too young or immunocompromised or have other Underlying Health 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 note that there has been comments made over and over again about vaccines and somehow vaccines causing cancers or miscarriages or the Covid Vaccine somehow has no effect on healthy people. These things are all false. I know you know this on your team knows this and i just want to reiterate that for the public. What i did want to say and have less time to do so, but i want to transition and thank you and your team what you are doing to relating listening to the lgbtq community. Myself, as an openly gay person, i really appreciate the fda moves and decisions allowing a gay man to be part of a solution when it comes to health and blood donations, when it comes to other forms of surrogacy, that the fda has really stepped forward, especially on the recent changing guidelines as it relates to lgbtq americans and gay men. Its comforting to know that if there was an emergency where my blood was needed, i would have that same right thanks to all of you. And the time i have remaining could you describe the fdas , draft proposal on how this helps advance equality and expands the donor pool as it relates to the recent changes you all are making . Dr. Califf first of all let me just say i appreciate your comments. On the vaccines, i want to point out, all medical interventions have risks as well as benefits. An earlier discussion if you , want to be alive and not be in an intensive care unit, get vaccinated. Some people do have side effects. It is important to take care of those. The benefits far outweigh the risks. The question you asked, people have raised this issue about donation for many years and we did a study that showed a questionnaire about behavior can do much better than just the timebased thing related to the lgbtq community. We are well along on that now and it looks like it is really going to work and will be consistent with what other countries are doing so we are really glad to have come to this conclusion. Mr. Garcia thank you very much for your work. I yield back. Mr. Comer the chair recognize mr. Fry from South Carolina. Mr. Fry thank you. Thank you for being here. Harm reduction is a pillar in the 2009 Tobacco Control act. The Strategic Plan embraced that Harm Reduction with the former fda commissioner, successfully implementing Harm Reduction could dwarf the introduction of any new medical Technology Impacts on our Public Health. The center for Tobacco Products leadership under the Biden Administration to have abandoned Harm Reduction as a principal by refusing to authorize other Tobacco Products that have been pending before your agency for years. Your agency is failing to acknowledge the need for real change and to provide Better Options for american smokers. A recent study that every ecigarette liquid that goes unsold due to flavor restriction, 15 additional cigarettes were sold. And found that ecigarette flavor restrictions yielded 20 increases in sales of cigarette brands disproportionately used by underaged smokers. Why has the fda authorized 900 new cigarettes . In the time it has authorized only a handle and full of vapor products . Dr. Califf first of all, we have not abandoned the principle you described. It is the responsibility of the company to produce the data set that shows the benefits of combustible tobacco reduction exceeds the risk due to getting teenagers addicted. Vaping products get people addicted to nicotine if they are a new user. So we always have to balance the risk of getting millions of teenagers addicted to the benefit of adults using combustible tobacco. There are 23 products that have met that standard and other companies are welcome to submit their data produce the data , showing they meet that Public Health standard. Mr. Fry does ctp still believe in the risk of switch from combustible cigarettes to smokefree alternatives . Yes or no. Dr. Califf there is not a yes or no answer. The best thing for adults is to stop using Tobacco Products altogether. The second best would be to switch to a vape. But the very best would be as we already discussed, if you look at the residue from vaping relative to no use of any tobacco product, it raises a number of issues. Mr. Fry the concern i have and concern that many people share, there seems to be abandonment of a congressional directive that we are going to pursue Harm Reduction as an actual strategy and if you have 900 cigarettes approved on only a handful of vaping products, there seems to be a divergence to what congress has outlined for your agency. Would you not agree with that . Dr. Califf i do not agree with the 900 cigarettes. I would have to go back and look at that. We have not abandoned the idea that the companies show it can successfully transition people from combustible tobacco to vaping in a way that does not increase the risk to teenagers of getting addicted to nicotine and therefore being susceptible to switching to tobacco. Mr. Fry would you consider that to be a Harm Reduction product . Dr. Califf we discussed this earlier. The term Harm Reduction tends to be used by industry to cover a lot of different areas. If there is a product that could cause someone to stop using combustible tobacco and not get teenagers addicted to nicotine that is a benefit. Mr. Fry there seems to be a reading about the fda there seems to be some pretty heavy backlogs in the agency. How are you utilizing your work force to innovate the fda and what type of metrics are you using to make sure you are being productive, not only for companies that have cropped products that go before you but for the American People . Dr. Califf as we discussed earlier today, i think everyone was surprised by the 26 million applications that came in and there was a big backlog and we now cleared 99 of the backlog. Just like all other parts of fda when applications come in, we , keep track of where we are and as we are employing Better Technology we are just going through some organizational changes, you are welcome to read the report we commissioned. We are hard at work and we want to do this as fast as we possibly can. Mr. Fry i yield back. Mr. Comer the chair recognizes ms. Presley from massachusetts for five minutes. Ms. Pressley let me acknowledge and thank you for your responsiveness and swift action on my outreach to you regarding formaldehyde and chemical hair relaxers and the shortage of childrens tylenol and motrin. Personally, as someone living with alopecia, i appreciate your efforts in that regard. And finally for the purposes of questioning, reproductive justice. Last year, the fda took steps to protect medication Abortion Access by allowing Abortion Pills to be prescribed by telehealth and distributed by retail pharmacy. Medication abortions accounted for 63 of all abortions performed in the United States last year. If met the press stone is pulled from the market, access to routine medical care would be jeopardized for people across the country. As part of their draconian unpopular goal for a National Abortion ban, lets call it what it is, forced to, which for money will result in forced death, republicans continue to try to block access to medication like mifepristone by spreading baseless conspiracy theories. The fake news is rampant. I have a teenaged daughter and we like to play a game called two truths and a lie. If you would indulge me we are , going to do a variation of that. I want to clarify some of the disinformation by playing a game called fact or fiction. Ill say a statement and say one word, fact or fiction. Lets start with this. Fact or fiction, the fda conducted a rigorous review and Extensive Research on mifepristone. Correct, thats a fact. Mifepristone has been on the market for 24 years and more than 100 studies have affirmed its safety since. Fact or fiction. Judges know better than health Public Health experts if medication abortion is safe. Dr. Califf Supreme Court is currently adjudicating a case that involves it. But i am on record, so are all of us, and it would be bad for the entire system of Drug Development and availability of medications in the United States if judges began overruling as a matter of routine. Ms. Pressley thats fiction, thank you. The fda, not the courts, derls the safety of drugs. Fact or fiction, mifepristone as a form of medication abortion is safe and effective. Dr. Califf fact. Ms. Presley correct, that is fact. Less than 1 of Patients Experience side effects, posing fewer risks even than advil or tylenol. The facts are adding up. It is safe, effective and form routine form of health care that remains necessary and legal across the nation. 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 life threatening. 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 policy makers and judges should not be the ones making decisions for them. If republicans and antiabortion extremists have their way, access to mifepristone will be cut in every state, blue or red, even in my district where abortion care is legally protected. Since i have been elected to congress, i have been proud to lead the task force under our prochoice caucus, fighting alongside my colleagues for mifepristone access. And abortion is a fundamental human right and i urge my colleagues to do the same. Thank you. And i yield. Mr. Comer chair recognizes mr. Burlison from missouri for five minutes. Mr. Burlison in may 2022, you made an appearance on cnn and claimed the leading cause of death in United States is misinformation. Do you recall being on that interview . Do you recall making that statement . Dr. Califf yes. Mr. Burlison you are right. You went on to say that in covid you need to get vaccinated that the reliable truthful messages are not getting across and washed out by a lot of misinformation which is leading people to make a lot of bad choices. I would like to draw your attention to a tweet i know you are familiar with. You are not a horse, you are not a cow, seriously yall, stop it. Another sarcastic tweet from the fda read hold your horses, it , may be trending but isnt authorized or approved to treat covid19. The fda put out these messages in 2021 and made similar posts on other platforms to discourage people from using ivermectin to prevent or treat covid. Then the fda was sued by a number of doctors who claimed you were practicing medicine as an organization. As part of a settlement you were , forced to delete these, is that correct . Dr. Califf thats correct. Mr. Burlison the u. S. Court of appeals says the fda is not a physician and tweetsized doses of medical advice is beyond your statutory authority, is that correct . Dr. Califf thats what the court said. Mr. Burlison claiming that ivermectin is horse medicine, would you not agree that is the exact definition of misinformation . Dr. Califf i would not agree with that. There were very well done randomized trials showing no benefit of ivermectins and. Mr. Burlison you knew that in 2021 . Dr. Califf i was not at the fda in 2021. Mr. Burlison you did not know. Ill ask the question. Even to this day, you have to correct misinformation about ivermectin because you created a narrative about the product which let me ask this. Ivermectin won the nobel prize, did it not . Dr. Califf for the treatment of worms. Mr. Burlison in humans. Dr. Califf four worms in humans. Mr. Burlison and next to penicillin and aspirin and considered as one of the wonder drugs and its effectiveness in humans, correct. Dr. Califf for a number of treatments for worms, and it is a medicine for animals also. Both are valid uses. Mr. Burlison at the end of the day you created in my opinion and i think its obvious because you are still having to correct people who think that a form of treatment that has been used how many times would you say historically has ivermectin been successfully used in medical treatment . Dr. Califf successfully used for worms. No successful treatment for mr. Burlison been administered in humans billions of times over the last what 30 years, correct . ,dr. Califf again, for the treatment of worms. Mr. Burlison let me ask this, do you think that tweets like this going to credibility to an organization like the fda . This is something i would think that my teenage daughters might write. Do you think that garners credibility with the fda and American People . Dr. Califf i cannot comment on that. Again i wasnt at the fda when , the tweet was put out. Mr. Burlison i am glad that the courts told you to remove these tweets, because it is snarky and demeaning to the American People and to people i believe in my district. I yield the rest of my time. Mr. Comer try to get a quick question in here, commissioner. You had mentioned in a previous question talking about hemp derived cbd oil, which is nonthc or. 3 or less. You mentioned that you did not think the fda could ever approve that as a pharmaceutical. Is that the fdas position . Because there are a lot of people in the hemp derived cbd industry that believe that cbd should be treated like supplements or vitamins and at gnc and vitamin world in places like that. Dr. Califf you are correct. We have a number of citizens petitions that have that belief. But Research Shows for example an elevation of liver enzymes where there is concern if people take this over time it could lead to damage the liver. Mr. Comer i have seen this in kentucky with many different cbd manufacturers. There is a big difference. Because it is the wild west, the fda will not regulate the product, there are companies with labs that would be as good as anything that merck and Johnson Johnson and there are people operating out of the garage in their house. The reputable cbd manufacturers in america i believe strongly hope the fda will come in and not just take samples because these companies are not the same, you agree with that, right . Dr. Califf this is where a good referee can be very helpful. Referee needs a rule book that says here are the rules and you write the rules so we would really like it if chair comer i hope to play a small role in that moving forward. Thank you. The chair recognizes ms. Crockett from texas for five minutes. Ms. Crockett thank you for being here. Youre 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 data is or we dont just ignore it, im not really sure. I dont know how long you were asked about ivermectin. I do not know if you have ever testified in court, but you would be a great witness because you refuse to answer the way he wanted you to, which would then again, put out more misinformation. Want to do a quick level fix on something and dont know how we continue to come back to this. But let me just ask you a few questions. Was covid19 real . Dr. Califf yes, i had it myself twice once or twice. Ms. Crockett did people die . Dr. Califf in the u. S. Alone , over one million people. It was in the top three causes of death for many months. I was an intensive care unit doctor. When i came to the fda, i stopped practicing but my friends in icus were overwhelmed. Hospitals had to have trucks backing up to the hospital because there wasnt enough room for all the dead people. Ms. Crockett and did vaccines save lives . Dr. Califf thanks for asking that again. Yes. People up to date on their vaccines have a significantly lower risk of being dead or admitted to a intensive care unit compared to those who were not up to date on the vaccine and worse of all people not vaccinated at all. That is true on an individual level. If you look at the counties, counties with a higher vaccination rate have lower death rates from covid. If you look at countries, you see the same general relationships. It is not perfect, but highly effective. Ms. Crockett i know theres no perfection, certainly not in this chamber. Nevertheless, as the result of an administration that believes in science and data, we now have arpah, stands for advanced Research Projects for agency and health. My district luckily was the recipient of a arpah Customer Experience centers and im so excited because this means as we are looking at trials, as were looking at diversifying them, we will have a great opportunity right there in texas. It is a Huge Investment in science to make sure that we can save lives. And when the next pandemic arrives, we actually will be prepared and have science so we can stay on top of this because the last time i checked, and doctor, correct me if im wrong, having a leader suggest that we should inject bleach, are you aware of anyone being cured of covid19 because they injected bleach into their body . Dr. Califf im unaware of any such thing. If i might comment in general, this relates back to the discussion about ivermectin. I focused on heart attacks. No one knew the cause of heart attacks. We tried a hundred Different Things for a heart attack and only a couple things worked and others didnt. The only way we knew what worked was we went from an idea of doing a well conducted study, a randomized trial and if it , worked, all the practitioners decided to adopt it and use it. We treat heart attacks by going to the cath lab and opening the artery and using medicines that work. Ivermectin has been used in many trials and no benefit but i use the word worms for the kinds of infections that typically occur in places like asia that can be devastating and it got a nobel prize because its effective for those and been a lifesaver but its been ineffective in covid. Ms. Crockett i completely understand. The last area im going to touch on in my last 45 seconds because im a woman out of the state of texas and theres no way i wont talk about reproductive access. Out of curiosity, would you consider the medical management of a miscarriage to be potentially a lifesaving usage, yes or no . Dr. Califf i have to be i have to decline to answer that. Ms. Crockett thats perfectly fine. Im going to tell you yes but give you another question you can answer. Would you consider erectile dysfunction a lifesaving use for viagra . Dr. Califf not lifesaving. Ms. Profit crockett not lifesaving. Viagra is actually 10 times later as a relates to risk of death and yet somehow it is not sitting here in the court right now. 10 times greater as it relates to risk of death. Yet somehow it is not sitting here in the port right now. I do appreciate the fact that you laid out that when it comes down to getting drugs approved, they actually go through trials. Its not just randomness. You take the randomness and then say maybe theres some evidence here and you put it through the ringer. After putting it through the ringer for decades, womens lives have been saved. And as a representative from the area that roe v. Wade actually initiated, im appalled because for whatever reason, some people want us to go back to horse and buggy in this country, and i think that since now maybe we have the internet, maybe we should take advantage of it and we shouldnt say we should remain in the times of horse and buggy. With that, thank you for the work that the fda does. I respect your research. I recognize the courts dont do research. I also recognize this chamber seemingly doesnt care about research, but because of the work that you do, there are lives being saved and i need you to be funded to the fullest extent to make sure that we continue to save american lives. Thank you. Chair comer the chair recognizes mr. Laturner from kansas. Mr. Laturner thank you for being here today. The fda holds the responsible of responsibility of ensuring the safety and integrity of the nations food drugs and Consumer Products, a responsibility that not only impacts our economy but also the health and wellbeing of every american citizens. Citizen. However, this fda has failed to meet its Mission Statement and is defined by crisis from persistent drug shortages to the most significant disruptive to the infant formula in history. We cant afford to overlook these failures. The wellbeing of all america depends on it. I look forward to hearing from you today and on how to address these pressing issues. Despite the backdrop of food and product safety issues plaguing your organization, the 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 can you explain to the committee what authority fda pursue this . And 260 three drugs remain in shortage. We have a lot of instructions about Food Labeling that we are adhering to and i would remind you that we have a shortened Life Expectancy and this country particularly in rural areas largely driven by diet and poor nutrition. It seems to me that putting the information on the front of the package is more likely to get the useful information so people can make wise choices. It does not seem to me like something that should be that hard to get to. If you put it on the back, if you are like me when you go to the store can you tell me where you derive the authority to do this . We are glad to get together with your staff and go through the details. Do you feel it is the best use of taxpayers dollars to shape americas eating patterns in lieu of addressing other Critical Issues . I listed other issues that are a pretty big deal. To back you tobacco is a huge one. Our lowlife expended seat is being driven by chronic diseases which are being driven by diet. So to say that we should pay no attention to diet is a mistake. Now shaping we are proposing getting people the information they need so they can make healthy choices and reduce these alarming rates of obesity, diabetes. I am a cardiologist, vascular disease. Ive spoken with my kelly ayotte cardiology it appears the agency has a number of outstanding rulemaking and goals that are not related to safety. The definition of healthy, simple for healthy, dietary guidelines for americans. Can you tell the committee and consumer is how all of these pieces fit together . My concern is that not only are you pursuing actions that you dont have the authority for but you are also painting a terribly confusing landscape of rules and advice about what to eat. Well, i would be happy to work with your staff and go into more detail but in short, what we now know about diet, it is the pattern of eating overtime and how long people live and if they are burdened by chronic diseases. It is not one specific thing. It is multiple constituents of the diet when eaten regularly and in a pattern and that creates the concepts of Health Problems ravaging our country. If you look at rural areas in particular, we are seeing alarming premature death rates going in the wrong direction for the first time in 50 years. My question specifically is that all of these initiatives and how they Work Together. It has been brought to my attention that elicit flavored ecigarettes make up a majority of the entire ecigarette market and most of these products are coming from china. Can you speak to the factors that have allowed this issue to materialize . It sure feels like warning letters are not getting the job done. We have had erect meetings that ive personally gone to to meet with the Border Patrol and customs people who are there when the stuff comes in. And if you want to get an education, go to the International Mail facility what about the doj . I have the key person cell phone number to call. I yelled back. The chair recognizes the gentlewoman from michigan. Im really pleased you are here. I had the last two weeks a handful of Community Events and fda issues did come up. I want to start with this. How much of what fda is doing covering specifically how much of your resources is dedicated to food safety . For a i would refer you to the report that we commissioned last year that has that detailed information. Nowhere near 50 . On the medical product side we have had very good funding. I do want to submit for the record an article, the fdas food failure. Without objection, so ordered. Fda right now has the authorization to regulate water to keep deadly toxin out, right . The water is mixed. We regulate bottled water. The water supply itself is regulated by epa as just noted. Water on farms goes from where cattle may be to plants im going to read from the article. By the time fda officials figured out it was spinach making people sick and 10 state sending three people into kidney failure, it was too late. It was mid november 2021 and the short shelf life had passed. There were no recalls. The fields and their production facilities were empty which made it impossible to pinpoint the source of contamination. What caused the outbreak was likely never fixed. How we fixed this kind of issue . It could be the watery used to clean the produce. When you say as it fixed . I would say i work on get the lead out. My colleagues know that im the leader on the equality of issue the quality of water. I just want to get to the bottom of what we can do together to ensure you have authorization to oversee Water Quality that touches our food. There are 10 rules. The agriculture the agricultural water role directs what a firm should do. What a farm should do. We can be in touch with your staff. We dont have anything right now that gives you the authority over the use of water on produce. Only in reaction to what happens. So after contamination. Not preemptive. That is important for us to know. The other question i have and it is also regarding food. Does the fda have authorization to oversee Food Packaging . What are we doing about the use of packaging around pfas . Food containers i was surprised to hear that we regulate dishwashers because of this. How do we do it . We have studies that sample but at really low rates. As we have discussed, we are going through the largest reorganization of the fda. I hear that we have some of the highest rates of cancer in the world. Is that correct . We do. I really think we should prioritize when we talk about the reorganization of fda i hope that we can Work Together in a bipartisan way to make sure that food safety is at the center of making sure that we have resources. This is me highlighting to my colleagues and educating the American Public that we need to do more about publix more about food safety. Jim jones who had a career at epa and as an expert on the kinds of things that you have raised and our reorganization plan calls for beefing up the chemical safety part of fda because we have had a very small staff historically in that area. The fdas moving towards trying to prevent the exposure of pfas. The fact that we are trying to stop the contamination of water, i think we have to be aggressive. The last question. Do you believe our country is experiencing a vaping epidemic . Epidemic is defined as millions of people. Yes. What you think we need to do as a congress to protect our residents but particularly our children . What do you think we should do . Vaping comes up so much for all of us no matter if we are republican or democrat. I think it has to be prioritized. We need more resources. Is it the disposable . The vaping industry does not pay user fees so we have a limited staff dedicated to this. We need to ramp up our staff. That is the most important thing that you can do. You are doing a good job of staying on our case and that needs to continue. Thank you, commissioner for sticking with us through the day. Your agency is responsible for valuating the safety and effectiveness of medications that millions of americans rely on. I am sure that the scientists that work there view themselves as committed public servants. Potential conflicts of interest. In 2018 the general of signs found that 11 ended up working for companies they previously were responsible for regulating. These pharmaceutical Companies Recruit former fda employees with lucrative job offers to leverage their connections. Existing law imposes only limited restrictions on this revolving door. Meanwhile, former fda employees can collect substantial paychecks. The lead medical officer for the fdas office of research and review took a high level job at moderna. And the medical officer that decided on behalf of of the fda about Clinical Data from darren is a vaccine medicine met critical standards also took a job with that company after the vaccine received light. I think you can see why Many Americans can look at the history of this and be very concerned about what is going on especially coming out of covid. Fda along with other agencies and i think it goes back to a lot of lessons learned. Right now, we are trying to restore the american populace is faith in these institutions. Can you speak to that issue did either of these officials recuse themselves . This last point you made is an important part of the system regardless of how you feel about the other parts of people moving from the fda into industry. You are prohibited from seeking a job in the area that you are regulating unless you recruit recuse yourself. But the fda has refused to acknowledge on these individuals whether or not they were accused of themselves of their involvement in these areas were leading going to moderna. Why has the fda refused to provide the information . I am unaware of what you are describing and we will look into that. If they were not seeking employment while they were regulating, than they did not violate anything. Did they seek guidance for approval did they seek guidance from the fdas ethic office before taking those jobs . I would think they would but i dont know that and we would have to go back. Can you understand the concern and what recommendations would you provide from 1981 until 2019 nine of the 10 commissioners went into work for pharmaceutical companies from leaving their office and you are one of those as well, im not suggesting impropriety. But you can see how this would create a huge concern, a conflict a conflict of interest when the American People are looking at this. What recommendations would you suggest we bring up to make sure that the American People can know that the decisions being made here is that thing. You are supposed to give oversight to these companies. And you know that you are not going to get a job, not you specifically. Someone who wants one of these highpaying jobs after leaving the department knows they will be hired by someone who is very strict on them. So there is a built in incentive to be lax. Why can we do in congress to provide a level Playing Field that will help restore the Publics Trust in this area . Im glad to engage in a discussion on this but i want to point out that inside the fda we are dealing with highly technical issues that require a lot of expertise. Many people work in the industry and come to the fda for a much lower salary because they are attracted to the issue of understanding the science and making good decisions based on it. By the same token, there are people that work in the fda for a period of time and they have skills and knowledge about an area. It is an issue does say that they can never work in an industry where they might develop a cure for cancer or whatever the thing may be. It is a delicate area. It needs to be looked at. Im not saying there is no legitimate reason. That is why im asking for your recommendations. What protections could we put . What recommendations would you provide that would not be onerous nine out of 10 going straight to the Pharmaceutical Company out of office is pretty circumspect when the American People are looking at that. What would you recommend for a congress that would be reasonable provisions allowing us to bring the full face of agencies back to the United States . His time has expired but please answer the question. It is a complicated area. I would say number one does making sure we adhere to what we already said. You raised questions about this. Exceptions are given all the time to these so there are rules but we wave them all the time. It is a self check kind of thing. I would not say that at all. I would speak very highly about our ethics office. I dont think exceptions are given all the time to these. But we can always do better. And im happy to engage on them. So, no recommendations . It is a broad area so im reluctant to offthecuff make a specific recommendation. We are going to try to go to mr. Ms. Conley, mr. Donald and then we will have just two votes. I think mr. Moscowitz is ahead of me. We will go to mr. Moscowitz them. Thank you for coming in today, commissioner. I want to turn your attention to a little bit of the aftermath of covid in the pharmaceutical space. You think it is appropriate, with all the supplying chain issues that america had during covid, that were not fixed in a broader sense but in the medical space, shouldnt we still be getting the majority of our drugs from wuhan . Should we still be depending on wuhan, china to be making drugs that we sell on shelves in our country . I would say im not sure specifically wuhan but the key starting materials for drugs are mostly coming from china and i dont think that is good for us. We dont need to have no drugs from china but we need a firm Manufacturing Base that we can be confident about. During the two bills, one in the Trump Administration and one in the Biden Administration when we spent 7 trillion combined, how come the fda was not advocating to start establishing, that we should start manufacturing those products here . I was not there at the time but i would just say that pretty much the time i came in in february 2022, we saw how stark the problem was and we started advocating then. But we live in a country where the pharmaceutical industry is forprofit. If people are not getting the prices they want or the purchaser is getting a lower price overseas, that is where they go. To fix this will take some kind of intervention which is well beyond the fda. We are advocating that intervention is needed. I know you got a bunch of questions about cancer drugs. My dad was diagnosed with pancreatic cancer and died 18 months before i ran. Do you think it is acceptable in america that families would get told by their doctor that we are going to have to push off a treatment because there is a shortage, a chemotherapy that is extending the lives, do you think it is acceptable in this country . And why is it that we are not more better we are not better prepared to handle when there are these manufacturing issues . Why are we not better prepared to handle these things . Heres what i would say. It is unacceptable. I have a close relative with pancreatic cancer right now and i know how frightening it is. We have hospitals and manufacturers that are mostly overseas. Five years ago it was 400 a dose. It is a generic drug. I gave it as an intern in 1978. Now it is 13 a dose. People running the company say, why should i make it . And we dont have a system in place that says, this is an essential drug. We are going to put something into place to cause the market to behave. I dont want to interrupt. You are the fda. There are all sorts of ways to be working with manufacturers all day long to incentivize them to make lifesaving drugs. We have no authority to give incentives. We are prohibited by law to deal with pricing. The hhs report came out last week and it goes through the details. I am in tune with your concern. I think people around the administration know that every time im on a call, i bring it up. There have been reports on some of the vaping products in florida seeing fentanyl in them. Why do we do about some of these illegal vaping products . Im very concerned about what you raised. We just had an annual meeting in atlanta with mostly parents of children that have died from overdose. The d. A. Administrator was there giving us details about how the products are getting into the mainstream of america through cartels predominately. Fda has a role. It is mostly a Law Enforcement issue with dea. We are working together as closely as we can but im not pretending that we have this Problem Solved at this point. It is a big deal. Mr. Donalds from florida. Commissioner, thank you for being here. I support the fdas efforts to reduce the Youth Smoking rates under their Current Authority granted by congress. What i do not support the unnecessary regulations like the fdas proposed standard for characterizing flavors in cigars rule which is purely based on more politics and science. What are some of the examples of the unintended consequences that might arise out of this role . Rule . The intended consequences would be the reduction in death rates does a 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. Do think it is wise for the fda to proceed . I think it is very wise to reduce the death rates. You did acknowledge and we are seeing it in a lot of markets associated with smoking, but right now we are focused on flavored cigars. Is it your contention that it is ok to put in this role around flavors in premium cigars because you have adults choosing to smoke flavored premium cigars . If you want to talk about flavored cigars i would say the youth is Smoking Cigars more than cigarettes. Flavored cigars are highly attractive to youth so it is a major concern we have. Premiums premium cigars is a different issue and i cant comment on that. California enacted a flavor brand on all Tobacco Products. Nearly 50 of all cigarettes used by consumers are purchased out of state. And packages were smuggled into california from international markets. In which way does an illicit Tobacco Market impact the u. S. . This was out in california four months ago and i met with the department of public. Their longevity is so much higher than the average of the United States. Largely due to the reduction in things like use of tobacco. They have low rates of use of tobacco. Overall, it is a net positive. Are we going to acknowledge that there are black products popping up whether it is illicit cigarettes or premium cigars in part because of the policies of the United States . As ive already discussed im a cardiologist and im used to life or death. Almost everyone prefers to be alive. I would like to reduce mortality than to tolerate 460,000 americans dying of tobaccorelated illness per year which is what our current rate is and that is lower than what it used to be. Im taking care of these people. We also have to acknowledge the fact that you are not omnipotent. You cannot control the actions of people. If they choose adults now, if they choose to smoke a cigar or a cigarette . And i dont agree with smoking cigarettes. Im not a cigarette smoker. But do we had the reality that when we put up these barriers we create an illicit market for these products that could be more harmful to the users. I would never pretend to be able to control the behavior of people. I imagine if we had taken that attitude when i started as a cardiologist, my average patient was 50 years old. Typically a man smoking cigarettes dying, 30 out of 100 people with a heart attack. The difficulty at the rates of use of tobacco drop so much. Not because is out because of informing the public or because of government regulation . I think it is a combination. I would argue it is better to get people to change behavior by informing them of the consequences of that behavior as opposed to putting up arbitrary rules. I would like that in general that is the reality of the human condition. When you are dealing with people suffering from addiction we have not gotten into a conversation about addiction but about fda rules around flavored cigars and some of the cigarette rules