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,