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Hearing Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role in Advancing U.S. Drug Development.
house Health Subcommittee · Jul 15, 2026 · Transcript · 25 transcript matches
DEGETTE, DIANA "Commissioner McCary and FDA leadership made major policy announcements through journal articles, press releases, and even podcasts, circumventing FDA's policymaking processes and making it so researchers did not know what the official policy was. FDA would even contradict its own past as in the case of experimental gene therapy for Huntington's disease. FDA reversed direction, demanding a new trial for the product, even though advocates and scientists believe the new trial to be unethical. Luckily, with the evidence that McCary has gone, things do seem to be slowly improving, and this is what..."
Hearing Healthier America: Legislative Proposals on the Regulation and Oversight of Food
house Health Subcommittee · Apr 29, 2026 · Transcript · 16 transcript matches
BARRAGÁN, NANETTE DIAZ "And how would they do that? Would they just put the word folic acid on there? Great. Thank you. Mr. Mandernauch, during the by heart infant formula recall, the FDA sent two warning letters to Walmart, Kroger, Albertsons, and Target to remove the contaminated formula from their shelves. Stores took up to two weeks to remove the recall formula off their shelves. What could the FDA have done better? And do current enforcement measures give the FDA enough authority to ensure immediate compliance in a recall, or does Congress need the process. Great. Thank you. Mr. Faber, the Trump administration..."
Hearing Hearings to examine FDA bureaucracy, focusing on regulator to roadblock.
senate Aging (Special) Committee · Feb 26, 2026 · Request transcript · 10 transcript matches
SCOTT, RICK "that sacrifice because care couldn't wait. My brother couldn't afford to sacrifice time. Congress has been clear. On an overwhelmingly bipartisan basis, we have given the FDA flexibility to move faster for patients with serious and life-threatening conditions. In 2016, Congress passed the 21st Century Cures Act. In that bill and other bills that followed, Congress gave direction to the FDA, encouraged the use of real-world evidence, highlighting that for a rare disease, drug development requires adaptability and urgency. These laws were meant to help cut through bureaucratic delays and give..."
Hearing Business meeting to consider S.2355, to amend the Public Health Service Act to provide for hospital and insurer price transparency, S.4189, to...
senate Health, Education, Labor, and Pensions Committee · Jul 22, 2026 · Transcript · 10 transcript matches
CASSIDY, BILL "But states and FDA don't consistently learn about these adverse events when they happen. FDA has stepped in to address some of these problems, but sometimes states and FDA are not always sure who's first when a situation"
Hearing Hearings to examine building a resilient health care future with biotechnology.
senate Health Care Subcommittee · Aug 4, 2026 · Transcript · 8 transcript matches
KEVIN OUTTERSON "Antibiotics are valuable, but the economic market is really undeniably broken. FDA approval should be a celebration for these companies. They should pop up as a quirk and celebrate, but the payday never comes for"
Hearing Hearings to examine the testimony of Anthony Fauci.
senate Homeland Security and Governmental Affairs Committee · Jul 29, 2026 · Transcript · 7 transcript matches
JOHNSON, RON "that. And I'll ask this question. Were you ever made aware of the fact that Peter Marks was warned that the algorithm was going to hide the safety signals? And were you told that senior FDA officials were given dozens, shown dozens of safety signals associated through is in that same month of March 2021, an employee at NIH, Dr. Nath, was diagnosed an employee at NIH, Dr. Nath, led a team of researchers who were"
CRS Report
How FDA Approves Drugs and Regulates Their Safety and Effectiveness
Reports · May 8, 2018
The Food and Drug Administration (FDA), a regulatory agency within the Department of Health and Human Services, regulates the safety and effectiveness of drugs sold in the United States. FDA divides...
CRS Report
Drug Shortages: Causes, FDA Authority, and Policy Options
Resources · Dec 27, 2018
Drug shortages have remained a serious and persistent public health concern, despite the prevention and mitigation efforts of Congress, the Food and Drug Administration (FDA), and health care...
CRS Report
Patent Listing in FDA’s Orange Book
InFocus · Jan 21, 2026
For over 40 years, the U.S. Food and Drug Administration (FDA) has maintained a resource formally titled Approved Drug Products with Therapeutic Equivalence Evaluations. This frequently updated...
CRS Report
Regulation of Laboratory-Developed Tests: FDA’s Proposed Rule
Resources · Apr 8, 2024
The Food and Drug Administration (FDA) defines laboratory-developed tests (LDTs) as a class of in vitro diagnostic (IVD) device that is designed, manufactured, and used within a single clinical...
CRS Report
FDA Regulation of Cosmetics and Personal Care Products Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
Reports · Oct 30, 2023
The Food and Drug Administration (FDA) has the authority to regulate cosmetic products and their ingredients. This authority was granted by the 1938 Federal Food, Drug, and Cosmetic Act (FFDCA),...
CRS Report
FDA Regulation of Over-the-Counter (OTC) Drugs: Overview and Issues for Congress
Reports · Dec 10, 2021
The Food and Drug Administration (FDA), under the Federal Food, Drug, and Cosmetic Act (FFDCA), regulates the safety and effectiveness of nonprescription (over-the-counter, or OTC) drugs sold in the...
CRS Report
FDA Human Medical Product User Fee Programs
Report · Mar 27, 2026
The Food and Drug Administration (FDA) regulates human medical products to ensure they are safe and effective for their intended use in patients. Medical products include prescription and...
Hearing Hearings to examine Biden Health Officials and COVID-19 Vaccine Safety Signals.
senate Permanent Subcommittee on Investigations · Apr 29, 2026 · Transcript · 5 transcript matches
SPEAKER_06 "and how he wanted, quote, correspondence on sensitive issues to be sent to me at my Gmail address, unquote. Included in this report is additional evidence of how federal health officials avoided creating a paper trail to prevent transparency and public disclosure. In discussing how they've been warned of a major limitation of FDA's data mining system, one senior FDA official wrote, quote, we should meet internally. Many considerations not suited to email, unquote. Other federal officials appear to have openly acknowledged that they were actively attempting to avoid transparency. A CDC..."
Hearing Lowering Health Care Costs for All Americans: An Examination of the Prescription Drug Supply Chain
house Health Subcommittee · Feb 11, 2026 · Transcript · 5 transcript matches
SPEAKER_38 "The lead in the world, yes, ma'am. Congresswoman, we need a modernized and reformed and bold changes at the FDA, and the core of that has to be the leadership and the staff at FDA. So when you look at the changes that have been made, they've been very difficult, and you've seen reductions in force. FDA, particularly scientific reviewers, medical reviewers, inspectors. That is the core, the gold standard of FDA for our industry in America and around the"
CRS Report
Legal Effect of Marijuana Rescheduling on FDA’s Regulation of Cannabis
Posts · Sep 16, 2024
Cannabis and its derivatives are regulated under various federal laws, depending on the particular characteristics and uses of the substance or product. Currently, unless an exception applies,...
CRS Report
FDA and Drug Prices: Facilitating Access to Generic Drugs
Resources · Jan 17, 2019
A variety of proposals to address high drug prices have been introduced in legislation and by the Trump Administration in its blueprint to lower drug prices. According to a Food and Drug...
CRS Report
FDA Regulation of Laboratory-Developed Tests (LDTs)
InFocus · Dec 19, 2025
Laboratory-developed tests (LDTs) are a class of in vitro diagnostic (IVD) device that is designed, manufactured, and used within a single laboratory. LDTs may be used in the context of identifying...
CRS Report
FDA Oversight of Food Safety and Foodborne Illness Outbreaks
Resources · Jan 10, 2025
Background The Centers for Disease Control and Prevention (CDC) estimate that foodborne pathogens account for 48 million illnesses, 128,000 hospitalizations, and 3,000 deaths per year. In 2024, the...
CRS Report
Health Claims on Food and Dietary Supplement Labels: FDA Regulation and Select Legal Issues
Resources · Oct 31, 2024
A food or dietary supplement manufacturer may seek to market a product through a statement on its product’s label that suggests a link between a nutrient in that product and a disease or...
CRS Report
Infant Formula Shortage: FDA Regulation and Federal Response
Resources · May 21, 2022
Some media sources report that as of May 8, 43% of infant formula was out of stock nationwide. This garnered widespread concern and significant congressional attention. This shortage may pose severe...
CRS Report
Drug Compounding: FDA Authority and Possible Issues for Congress
Reports · Jan 5, 2018
Drug compounding is a process by which a pharmacist or physician combines, mixes, or alters various drug ingredients to create a drug to meet the unique needs of an individual patient for whom an...
CRS Report
FDA Regulation of Tampons
Posts · Oct 11, 2024
An August 2024 study led by researchers at Columbia University evaluated the concentration of 16 different metals in multiple brands of tampons and reported detecting measurable concentrations of all...
Hearing “Restoring Trust in FDA: Rooting Out Illicit Products”
house Oversight and Government Reform Committee · Apr 9, 2025 · Request transcript
Hearing Examining the FDA’s Regulation of Over-the-Counter Monograph Drugs
house Health Subcommittee · Apr 1, 2025 · Request transcript
Testimony DEGETTE, DIANA
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"Commissioner McCary and FDA leadership made major policy announcements through journal articles, press releases, and even podcasts, circumventing FDA's policymaking processes and making it so researchers did not know what the official policy was. FDA would even contradict its own past as in the case of experimental gene therapy for Huntington's disease. FDA reversed direction, demanding a new trial for the product, even though advocates and scientists believe the new trial to be unethical...."
Testimony DR. THOMAS HWANG
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"of these institutions that could be centers of excellence could speak to kind of your concerns of work does FDA fund externally? FDA has a lot of important grant mechanisms, specifically in the Office of Orphan Products. FDA grants to rare disease clinical trials, including those for ALS, have supported new product approvals, and all of that research is at should be withdrawn? I'll start with you, Dr. Hwang. I'm still reviewing the proposed rule, but as written, I have serious concerns before..."
Testimony BARRAGÁN, NANETTE DIAZ
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"hostility to international students, and attacks on research universities. And that's why I'm asking you, because you wrote about this specific thing. Let me ask you another thing about, because this hearing is about biomedical innovation, and it's interesting that it says the role of the FDA when we're gutting the FDA and the FDA is collapsing. How about placing blanket tariffs on pharmaceuticals? Is that going to help the"
Testimony BARRAGÁN, NANETTE DIAZ
Healthier America: Legislative Proposals on the Regulation and Oversig...
house Energy and Commerce Committee · Apr 29, 2026
"And how would they do that? Would they just put the word folic acid on there? Great. Thank you. Mr. Mandernauch, during the by heart infant formula recall, the FDA sent two warning letters to Walmart, Kroger, Albertsons, and Target to remove the contaminated formula from their shelves. Stores took up to two weeks to remove the recall formula off their shelves. What could the FDA have done better? And do current enforcement measures give the FDA enough authority to ensure immediate compliance in..."
Testimony MR. SCOTT FABER, JD
Healthier America: Legislative Proposals on the Regulation and Oversig...
house Energy and Commerce Committee · Apr 29, 2026
"affordable food, and we were all hopeful that Secretary Kennedy would deliver on his promises to make America's food healthier and make us healthy again. So far, we've not banned a single chemical from our food, and that's in part because we lack the staff capacity to adequately review and act on chemicals of concern. We have organizations like EWG have eight petitions pending at the FDA right now, many of which are urging the FDA to ban chemicals that have been banned elsewhere and that are..."
Testimony FLETCHER, LIZZIE
Healthier America: Legislative Proposals on the Regulation and Oversig...
house Energy and Commerce Committee · Apr 29, 2026
"The work the FDA does is essential to public health, and that is why it is critical that we ensure that the agency has the proper tools to do its work. And while many of the bills that we're discussing today are important for ensuring that the FDA is able to protect the safety of our food system, I find it not only ironic but distressing to be discussing the importance of the FDA while the Trump administration has spent the last year cutting staff at FDA that does this work. And this Congress..."
Testimony FLETCHER, LIZZIE
Healthier America: Legislative Proposals on the Regulation and Oversig...
house Energy and Commerce Committee · Apr 29, 2026
"And I want to direct a couple of questions to you, Mr. Faber, about can you just talk about how the staffing cuts at FDA have impacted the FDA's ability to regulate our food? Thank you so much, Mr. Faber. And I want to follow up on that with another point, which is, while today's hearing is focused on the FDA's work in food regulation, I have also been concerned about reports that have come up that we've heard that the FDA, not only the number of staff, but the integrity of the staff and the..."
Hearing “Medicines and IP: Balancing Innovation and Access”
house Courts, Intellectual Property, Artificial Intelligence, and the Internet Subcommittee · Jun 4, 2026 · Transcript · 3 transcript matches
ISSA, DARRELL "The fact is that we're going to discuss all of that, and we're going to ask our very knowledgeable witnesses to opine on it. The subcommittee's jurisdiction, though, is in fact limited to patents. It does not include the FDA, and so in spite of the fact that you may hear complaints about both the FDA and middleman insurance reimbursement, please understand this is not something we can deal with today, and we would encourage all of our witnesses and members of the committee to concentrate to the greatest extent possible on that which is in the committee's jurisdiction, because it is broad and..."
Hearing Hearings to examine truth in drug labeling.
senate Aging (Special) Committee · Jan 29, 2026 · Transcript · 3 transcript matches
STEPHEN W. SCHONDELMEYER "FDA may well have all of this information and other information on quality, but they either aren't authorized or as a matter of policy don't choose to release a lot of it. And so just having the information at FDA doesn't necessarily improve the quality and the ability of decision makers to make decisions, whether it's the consumer or the prescriber or the pharmacist or the purchaser, they need to know what FDA knows to make those decisions. So made by or product of, and API product of, finished dosage form product of, in that"
Hearing “Building an AI-Ready America: How AI Is Creating Opportunities Across America's Workforce”
house Education and Workforce Committee · Jul 24, 2026 · Transcript · 3 transcript matches
DR. JEFFERY TALBERT "Deep learning models have been shown to predict acute kidney injury up to 48 hours before traditional clinical recognition. FDA-cleared AI systems for diabetic retinopathy can identify patients at risk for preventable blindness in primary care settings, allowing interventions before disease progression. We are also beginning to see AI accelerate the development of new"
Testimony DR. CYNTHIA VERST
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"Congress should consider encouraging the definition and use of fit for first in human minimum data sets based on complexity and risks to support the safe to proceed decisions, and that would, in essence, speed the U.S. starts without lowering the standards or compromising patient safety. Third, this fit for first in human focus at the IND application review will defer important conversations later in development. However, this will require more flexibility and capacity for FDA reviewers to..."
Testimony DR. CYNTHIA VERST
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"and an FDA empowered to provide more iterative scientific engagement to help our sponsors start more early phase trials here in the U.S. while maintaining the patient protections and data integrity that make the FDA the global gold standard. And, of course, IQVIA is continuing to be committed to help the Congress, FDA, HHS, and, of course, other stakeholders to enhance this clinical research efficiency and, most importantly, helping our patients receive medicines faster. Thank you. And let me..."
Testimony MS. SUSAN WINCKLER
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"Chairman Griffith, Ranking Member DeGette, and members of the subcommittee, thank you for the opportunity to testify today. I am Susan Winkler, Chief Executive Officer of the Reagan-Udall Foundation for the FDA. I'm a pharmacist and an attorney by training and have observed drug development from many vantage points, including as FDA's Chief of Staff under both Republican and Democratic commissioners. Part of my role there involved negotiating product safety agreements with China. The Foundation..."
Testimony MS. SUSAN WINCKLER
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"FDA-regulated industry, patient groups, and regulators to deliberate shared challenges with candor. The resulting recommendations align with much of Operation Trial Blazer. This is encouraging. When the people who run trials, treat patients, and generate evidence arrive on their own at the same conclusions as the regulatory agency, it's a strong signal that the reforms are sound and ready to implement. But more can be done. The goal is a stronger American system, and the surest way to lead is..."
Testimony DR. AARON KOWALSKI
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"So I know firsthand the constant challenges of managing this disease, as well as the promising science on the horizon. I've also worked with FDA for nearly 20 years, and I can say with pride that my family and our broad type 1 diabetes community has benefited directly from American innovation and FDA"
Testimony DR. THOMAS HWANG
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"Congress could examine requiring that a minimum percentage of non-U.S. trial sites undergo FDA inspection. Third, and finally, as part of the FDA's Operation Trial Blazer, the FDA could pilot coordinated submission and review of investigational new drug and investigational device exemption applications with international partners, which allow new drugs and devices to begin clinical testing. Ultimately, any durable effort to promote U.S. clinical development requires investment and public..."
Testimony MR. THOMAS BOLLYKY
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"The agency has lost real experience and expertise. Adding a user fee to enhance the number and quality of GCP inspections for IND submissions inspections for IND submissions with foreign clinical trial data would help boost FDA's inspection capacity. In conclusion, the same dynamic that hollowed out U.S. generic drug manufacturing is now playing out in biotechnology, but at an earlier stage when FDA and congressional intervention would be effective and is thus more urgent. The time to act is..."
Testimony GUTHRIE, BRETT
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"was reflecting the needs of the community. We have a number of colleagues in Congress who were combat veterans and have had this treatment and have lots of friends and have talked of this treatment and feel it's really effective. Hopefully we can figure out a pathway, if it is effective, to find it's effective and give access, if so. So thanks. So Dr. Kowalski, in Breakthrough T1D, you've worked closely with FDA and product developers to advance all the innovative clinical designs and trials..."
Testimony MR. THOMAS BOLLYKY
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"It is decades of coordinated state intervention and investment. And while it's critical, as many of the witnesses have discussed here, to invest in making the U.S. more competitive, we need to acknowledge that FDA acceptance of foreign clinical trial data depends on its compliance with good clinical practices, that it's conducted under independent ethics review, and the ability of FDA to inspect, and we cannot maintain that standard for the amount of activity in"
Testimony HARSHBARGER, DIANA
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"Okay. Ms. Winkler, stakeholders often tell us that one FDA review division may expect something entirely different from another. So how important is it to get greater consistency across the FDA review divisions for encouraging companies to keep early-stage development here in the United States? I got"
Testimony DR. CYNTHIA VERST
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"or if you will, all of the HHS divisions coming together. We talked here today about, of course, the FDA, and I know it's not within the scope, We talked here today about, of course, the FDA, but that adjacency will be critical, especially, for instance, we talked about today,"
Testimony CAMMACK, KAT
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"countries that share our regulatory standards and commitment to high-quality science. At the same time, FDA has made it clear that it can rely on foreign clinical data only when it has confidence in the integrity of that data. As more early-stage development takes place around the world, that confidence depends on FDA having the resources to inspect the foreign trial sites and verify compliance with good clinical practice standards, something I don't have the confidence in right now. As..."
Testimony BARRAGÁN, NANETTE DIAZ
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"Thank you, Mr. Chairman. Mr. Boykia, I want to start with you. I have this chart that I used in July of 2025. It's an FDA organizational chart. I don't know if you could see it from where you are, but basically what it is, is it has the different sections of FDA, and when I use this, actually, this is now gone. We've got four more gone. This is now gone. We've got four total, but one of them that's been gone, I want to point out, is the food oversight, and why am I bringing up food oversight?..."
Testimony BARRAGÁN, NANETTE DIAZ
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"is a good thing? to do its job. Okay, so right around the same time that I was using this chart, you retweeted this article called Inside the Collapse of the FDA from the New York Times. Would you agree that it's important that we have experienced voices and institutional knowledge at the FDA? And do you agree that we need to protect the U.S. system of biomedical"
Testimony KEAN, THOMAS H.
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"biotechnology industry that not only provides jobs locally but provides the world with therapies that improve and extend life. Ms. Verst and Ms. Winkler, my district is home to numerous small rare disease companies. These constituents and other companies have frequently raised concerns about inconsistency and even within FDA review divisions. This is a significant source of uncertainty that translates to an unpredictable regulatory environment and disincentives investment in rare in areas of..."
Testimony MS. SUSAN WINCKLER
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"comes in late, or there was a lack of clarity, or sometimes sponsors don't always listen perhaps as Both of you. Yes, so thank you and there are a couple of ways. One, I'll say that the FDA's rare disease innovation hub has actually been quite helpful in bringing together not only the different product centers at FDA, so Center for Biologics, Center for Drugs, and Center for Devices and stimulating the conversations so that they can have a better understanding of what endpoint might be relevant..."
Testimony DR. THOMAS HWANG
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"Again, I think a loss of investment in American science does a big disservice to our efforts to create new therapies. As we've heard from other members of this panel, FDA has an incredible role in the innovation ecosystem and our leadership over the past two decades relies on a well-functioning and well-staffed FDA. Representative, first I would start by asking how much time you"
Testimony LANDSMAN, GREG
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"She's got to be a doctor. Given the FDA's current framework, what changes at the FDA would best support biosimilars and other generics entering the market? You're very close to this, obviously. But is it not true that when the FDA approves a biosimilar, there's still additional"
Testimony SCHRIER, KIM
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"into more complicated and scientific elements. I wanted to pivot a little bit to vaccines because there's been a lot of discussion, information, and a lot of misinformation about vaccine safety. And I wanted to just point out first, long before a vaccine ever reaches a clinic, the FDA does really thorough vetting and the determination of safety and efficacy through gold-standard clinical trials. And once it is licensed, it then goes to the CDC's Advisory Committee on Immunization Practices, or..."
Testimony MS. SUSAN WINCKLER
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"others – there is the risk of what we do not control being weaponized against the United States, and particularly in biomedical innovation and simply access to biomedical products or food or, you know, these things that are essential to life. We should be positioning the U.S. for greatest success so that we are less susceptible to such challenges. So I'll just make one observation and to remind us that when FDA approves a product, whether it's a vaccine or a drug or a biologic or a device,..."
Testimony TRAHAN, LORI
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"which is absolutely critical in my home state of Massachusetts and to every American who's desperately waiting on a cure. This hearing is based on a real threat, that we're losing our edge to China. But I want to be clear, you know, under this administration, we're not being outpaced. We're forfeiting. Before any promising new therapy even reaches the FDA, there's discovery, there's preclinical work, there's first-in-human testing, and almost all of it traces back to NIH. Nearly every drug the..."
Testimony MULLIN, KEVIN
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"we must also be forward-thinking about ways for the FDA to modernize processes as the science continues to advance. So, Ms. Winkler, your testimony highlighted that current FDA communication with drug sponsors leads to guesswork and overly conservative assumptions that ultimately slows down the process. So, what more does the FDA and Congress need to do to streamline these interactions and ensure responses are clear and"
Testimony DEGETTE, DIANA
Healthier America: Legislative Proposals on the Regulation and Oversig...
house Energy and Commerce Committee · Apr 29, 2026
"They deserve to have the ease of reading food labels, free of misleading terms, to find out whether a product is right for them. And Mr. Chairman, you know that better than anybody. But right now, the onus for deciphering which foods are healthy and avoiding harmful substances falls overwhelmingly on the consumer. Now, this should be why we have an FDA, so that Americans across the country have the information that they need to make healthy choices. And I had many conversations with former..."
Testimony MR. SCOTT FABER, JD
Healthier America: Legislative Proposals on the Regulation and Oversig...
house Energy and Commerce Committee · Apr 29, 2026
"We should not make our food safety system worse by allowing chemical companies to completely bypass FDA review altogether and, as one bill that is the subject of today's hearing proposed, instead allow industry-funded panels of industry insiders to simply approve new chemicals and immediately add them to our food. We should not reduce the amount of information that we're sending to FDA, nor should we allow a new chemical to be presumed safe simply because the FDA has missed a deadline. Most..."
Testimony MR. SCOTT FABER, JD
Healthier America: Legislative Proposals on the Regulation and Oversig...
house Energy and Commerce Committee · Apr 29, 2026
"and we know that they're not only linked to serious health harms like diabetes, but they're engineered to be literally irresistible, not just delicious, but to be irresistible in ways that interfere with our brain's reward centers. Unfortunately, the FDA isn't even, FDA is not considering some of the questions you've raised, Mr. Chairman, is this cause, might this cause a serious health harm, might it cause a reaction. They're also not considering the extent to which these additives and..."
Testimony MR. SCOTT FABER, JD
Healthier America: Legislative Proposals on the Regulation and Oversig...
house Energy and Commerce Committee · Apr 29, 2026
"So, I'll just say, I think quite obviously the FDA doesn't have the resources it currently needs to make sure the chemicals we eat every day are safe. Some combination of fees, user fees, other fees is necessary to make sure that FDA can do the job that Mr. Colillo described, and the good news is industry benefits from FDA having the resources to do their job because consumers have more confidence and they are more likely to enjoy the products that they're offering in their stores. Thank you..."
Testimony MR. SCOTT FABER, JD
Healthier America: Legislative Proposals on the Regulation and Oversig...
house Energy and Commerce Committee · Apr 29, 2026
"But it is true that companies can submit a GRAS notice. If the FDA has questions, they can withdraw the notice and bring the chemical into food anyways, even though the FDA had questions about the harms that that chemical might cause. We don't know, because they are secret GRAS"
Testimony MR. SCOTT FABER, JD
Healthier America: Legislative Proposals on the Regulation and Oversig...
house Energy and Commerce Committee · Apr 29, 2026
"One big problem is resources. The FDA simply doesn't have enough people to manage recalls and to make sure that contaminated product has actually been removed from the shelves. As we think about how to properly fund the FDA, it's not simply a question of we're able to do food chemical reviews or inspect infant formula plants. We also need resources to make sure that we're properly executing recalls and really making sure that contaminated product isn't getting into our homes. Thank you for the..."
Testimony MR. SCOTT FABER, JD
Healthier America: Legislative Proposals on the Regulation and Oversig...
house Energy and Commerce Committee · Apr 29, 2026
"I think it goes without saying these are sensitive populations. Infant formula is often the sole source of nutrition for our babies. If a company detects a pathogen in an infant formula manufacturing facility, they should be required to notify the FDA immediately so the FDA can be a partner in understanding what the risks might be. As you said, one of the bills that we're considering today would require immediate notification within 24"
Testimony LANDSMAN, GREG
Healthier America: Legislative Proposals on the Regulation and Oversig...
house Energy and Commerce Committee · Apr 29, 2026
"we have seen cases where Congress has provided FDA with very important authority to keep people safe, but there has been either the appearance of corruption, corruption or abuse of power that has gotten in the way of that authority in making appropriate decisions. So I'm going to give one example and ask some questions because it is very concerning to me. The FDA was dealing with this E. coli outbreak, and multiple state and local health partners and the FDA determined that the outbreak was the..."
Testimony BARRAGÁN, NANETTE DIAZ
Healthier America: Legislative Proposals on the Regulation and Oversig...
house Energy and Commerce Committee · Apr 29, 2026
"Great. Thank you. Mr. Mandernauch, during the by heart infant formula recall, the FDA sent two warning letters to Walmart, Kroger, Albertsons, and Target to remove the contaminated formula from their shelves. Stores took up to two weeks to remove the recall formula off their shelves. What could the FDA have done better? And do current enforcement measures give the FDA enough authority to ensure immediate compliance in a recall, or does Congress need the process. Great. Thank you. Mr. Faber, the..."
Testimony FLETCHER, LIZZIE
Healthier America: Legislative Proposals on the Regulation and Oversig...
house Energy and Commerce Committee · Apr 29, 2026
"So instead, I think that we really need to focus on what this Congress can do to check the actions of the administration that are undermining food safety and the health of all Americans. And I want to direct a couple of questions to you, Mr. Faber, about can you just talk about how the staffing cuts at FDA have impacted the FDA's ability to regulate our food? Thank you so much, Mr. Faber. And I want to follow up on that with another point, which is, while today's hearing is focused on the FDA's..."
Testimony CARTER, TROY A.
Healthier America: Legislative Proposals on the Regulation and Oversig...
house Energy and Commerce Committee · Apr 29, 2026
"oversee food safety, and respond effectively to outbreaks of illness. A depleted FDA workforce means less protection for our public. Mr. Faber, what staffing issues have you seen at the FDA? What impact does that have on food"
Testimony LANGWORTHY, NICHOLAS A.
Healthier America: Legislative Proposals on the Regulation and Oversig...
house Energy and Commerce Committee · Apr 29, 2026
"We have a thriving cheese manufacturing in the state of New York, and I just wanted to express my strong support for that legislation, and hopefully that moves forward very soon. Into my line of questioning, for nearly 30 years, dietary supplements have been regulated under a single science-based national framework led by the FDA, giving consumers confidence that products are safe and properly labeled and consistently regulated across the country. But in recent years, as we've seen in many..."
Testimony CASSIDY, BILL
Business meeting to consider S.2355, to amend the Public Health Servic...
senate Health, Education, Labor, and Pensions Committee · Jul 22, 2026
"But states and FDA don't consistently learn about these adverse events when they happen. FDA has stepped in to address some of these problems, but sometimes states and FDA are not always sure who's first when a situation"
Testimony BALDWIN, TAMMY
Business meeting to consider S.2355, to amend the Public Health Servic...
senate Health, Education, Labor, and Pensions Committee · Jul 22, 2026
"As drafted, the legislation could require many dairy products, including milk, cheese, and yogurt, to carry an FDA warning label unless the FDA chooses to exempt them through its regulatory authority. This places tremendous weight on agency discretion rather than providing a clear direction"
Testimony CONAWAY, HERBERT C.
H.R.4398, the “Veteran Burial Timeliness and Death Certificate Account...
house Veterans' Affairs Committee · Jun 30, 2026
"Within the VA system? And just, and so it's an advice that has been approved by the FDA for a particular clinical use that we're, this was not an experimental device, it was one that was already approved by FDA or? I"
Testimony COLLINS, SUSAN M.
Business meeting to consider S.1782, to prohibit discrimination on the...
senate Health, Education, Labor, and Pensions Committee · Jun 17, 2026
"works. It increases competition from generic drugs through better oversight of the FDA citizen petition process. Brand name manufacturers were behind roughly 86% of all citizen petitions filed between 2016 and 2019. Overwhelmingly, these petitions did not raise legitimate safety concerns, which is why the FDA rejected more than 9 out of 10 of these petitions. Despite the low success rate, petitions are still able to delay generic drug entry and can unfairly consume FDA resources. Our bipartisan..."
Testimony ISSA, DARRELL
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"The fact is that we're going to discuss all of that, and we're going to ask our very knowledgeable witnesses to opine on it. The subcommittee's jurisdiction, though, is in fact limited to patents. It does not include the FDA, and so in spite of the fact that you may hear complaints about both the FDA and middleman insurance reimbursement, please understand this is not something we can deal with today, and we would encourage all of our witnesses and members of the committee to concentrate to the..."
Testimony MS. KRISTA HESSLER CARVER
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"Yes. The therapeutic equivalence of the generic would be listed in FDA's orange book for everyone to see. I think on the Skinny Labels Act, one thing that was brought up previously is the question of whether the label does or does not mention the patented use. And to me, that's a really critical part of this question. It's FDA that's reviewing the labeling of a generic, and they are not equipped, both from an authority perspective as well as an expertise perspective in determining whether..."
Testimony CLINE, BEN
“Medicines and IP: Balancing Innovation and Access”
house Judiciary Committee · Jun 4, 2026
"Ms. Carver, in practice, to sell a generic, a company has to communicate that its product is a generic of or therapeutically equivalent to the brand. It's a routine, necessary part of marketing any generic, correct? Right. But the FDA itself does not review a generics carve out for patent inducement adequacy. In fact, hasn't the FDA said it lacks the authority and expertise in the courts or the appropriate forum? Okay. Ms. Simpson, as we have been talking about, with the decision, doesn't after..."
Testimony BILIRAKIS, GUS M.
Full Committee Markup of 16 Bills
house Energy and Commerce Committee · May 21, 2026
"including clinical trial enrollment, safety reporting, and the use of small patient population data to support future approvals. It also strengthens oversight by requiring an updated FDA action plan and additional reporting on FDA's progress. Importantly, this legislation recognizes that advances made in ALS research may also help patients living with other rare neurodegenerative diseases. While there is still much work to be done, continuing to support research, innovation, and access to..."
Testimony CARTER, TROY A.
Full Committee Markup of 16 Bills
house Energy and Commerce Committee · May 21, 2026
"I'm proud to speak in support of H.R. 2821, the FDA Modernization Act 3.0, introduced by Representative Buddy Carter, which I am proud to co-lead with the bipartisan coalition of my colleagues, Representative Barragan, Buchanan, DeLauro, and Hochberger. Over three years ago, the FDA Modernization Act 2.0 was signed into law, allowing the FDA to approve human drugs without requiring animal testing through modern, often more effective alternatives. However, since then, the FDA has not issued..."
Testimony SPEAKER_06
Hearings to examine Biden Health Officials and COVID-19 Vaccine Safety...
senate Homeland Security and Governmental Affairs Committee · Apr 29, 2026
"and how he wanted, quote, correspondence on sensitive issues to be sent to me at my Gmail address, unquote. Included in this report is additional evidence of how federal health officials avoided creating a paper trail to prevent transparency and public disclosure. In discussing how they've been warned of a major limitation of FDA's data mining system, one senior FDA official wrote, quote, we should meet internally. Many considerations not suited to email, unquote. Other federal officials appear..."
Testimony SPEAKER_06
Hearings to examine Biden Health Officials and COVID-19 Vaccine Safety...
senate Homeland Security and Governmental Affairs Committee · Apr 29, 2026
"less than three months after the COVID injections received an emergency use authorization, Peter Marks, the head of CBER and officials reporting to him, were warned by FDA's Dr. Anna Scharfman, an individual who these officials recognize as an expert in FDA's data mining, that the current system would mask safety signals for COVID injection adverse events. Dr. Scharfman proposed a new model, a new method, invented by Dr."
Testimony SPEAKER_06
Hearings to examine Biden Health Officials and COVID-19 Vaccine Safety...
senate Homeland Security and Governmental Affairs Committee · Apr 29, 2026
"or take action to warn the public. Instead, senior FDA officials repeatedly tried to stop Dr. Scharfman from continuing her work or communicating her findings outside of FDA. In September 2021, Dr. Marks informed Dr. Patricia"
Testimony SPEAKER_02
Hearings to examine Biden Health Officials and COVID-19 Vaccine Safety...
senate Homeland Security and Governmental Affairs Committee · Apr 29, 2026
"Today's report shows that senior FDA staff were apprised of the masking problem both prior to COVID vaccine rollout and repeatedly by Dr. Anna Schaffman. Dr. Schaffman is a veteran FDA statistician lauded for bringing the empirical Bayesian method into FDA after collaborating with its inventor and developer of the associated Empirica signal"
Testimony SPEAKER_02
Hearings to examine Biden Health Officials and COVID-19 Vaccine Safety...
senate Homeland Security and Governmental Affairs Committee · Apr 29, 2026
"events that you've listed there, these are all showing signals for the Bayesian data mining and also not only that, in the PRR method, which is masked, they're showing signals. So whichever way you look at it, there's signals. And the key point, Senator, is that for the purpose of the EUA, the FDA will require to consider not only actual proven risks, but potential risks. And potential risks are represented by signals without necessarily having to prove causality. But in all the decisions, the..."
Testimony SCOTT, RICK
Hearings to examine FDA bureaucracy, focusing on regulator to roadbloc...
senate Aging (Special) Committee · Feb 26, 2026
"that sacrifice because care couldn't wait. My brother couldn't afford to sacrifice time. Congress has been clear. On an overwhelmingly bipartisan basis, we have given the FDA flexibility to move faster for patients with serious and life-threatening conditions. In 2016, Congress passed the 21st Century Cures Act. In that bill and other bills that followed, Congress gave direction to the FDA, encouraged the use of real-world evidence, highlighting that for a rare disease, drug development..."
Testimony SCOTT, RICK
Hearings to examine FDA bureaucracy, focusing on regulator to roadbloc...
senate Aging (Special) Committee · Feb 26, 2026
"Patients from every state come and talk to our offices, sharing their irreversible declines in health that happen while they or someone they care about waits for a treatment that might never come. It's heartbreaking to hear from families who are left watching their loved ones deteriorate while promising therapies remain stuck in review. Meanwhile, small biotech companies struggle to survive years of uncertainty even when their science is sound. Beyond individual patients, there are serious..."
Testimony GILLIBRAND, KIRSTEN E.
Hearings to examine FDA bureaucracy, focusing on regulator to roadbloc...
senate Aging (Special) Committee · Feb 26, 2026
"cause irreversible harm, and in some cases premature death. This is also frustrating for drug sponsors who face increased costs and delayed timelines that impact the viability of their clinical trials, particularly in the United States. Uncertainty shapes behavior across the biotech ecosystem. Without consistency and predictability, drug sponsors will continue to struggle with seeking FDA approval and will take their clinical trials elsewhere, like to China. This is bad for business, and it's..."
Testimony JEREMY SCHWALMAN
Hearings to examine FDA bureaucracy, focusing on regulator to roadbloc...
senate Aging (Special) Committee · Feb 26, 2026
"neurodegenerative diseases worsen inexorably. And in this business, staying the same is success. Like other rare diseases, Ataxia is difficult to study, deteriorates slowly, and manifests differently, even within families. There are 15,000 Ataxia patients in America. Some affect hundreds of people, some just a few. Now Congress says you've told us recognize these challenges and passed legislation mandating that FDA use regulatory flexibility and real that FDA use regulatory flexibility and..."
Testimony NEILL
Hearings to examine FDA bureaucracy, focusing on regulator to roadbloc...
senate Aging (Special) Committee · Feb 26, 2026
"devastating diseases, but sadly, flexibility and speed are not actually what most rare disease patients are witnessing. Transformative therapies are at FDA's doorstep, and so with great respect, families are pleading for FDA to unlock the door and move with urgency so that our children can have a chance at the life they deserve. Thank"
Testimony JEREMY SCHWALMAN
Hearings to examine FDA bureaucracy, focusing on regulator to roadbloc...
senate Aging (Special) Committee · Feb 26, 2026
"These little tiny glitches that the FDA is producing land up not approving drugs and patients die as a consequence. I'm glad to hear that there are people in the FDA who are doing what Congress requires them to do, but that speaks to the unpredictability and the erratic nature of the responses and the performance of the people in the FDA. There are many ways to go forward to use clinical trials and then use the new technology to bring treatments to patients faster that are safe and make a..."
Testimony GILLIBRAND, KIRSTEN E.
Hearings to examine FDA bureaucracy, focusing on regulator to roadbloc...
senate Aging (Special) Committee · Feb 26, 2026
"Thank you. In 1972, the Federal Advisory Committee Act established advisory committees within the FDA to help provide independent and expert scientific input on product reviews and policy topics. In 2025, FDA canceled many advisory committee meetings and indicated that it would like to move away from involving advisory committees in the review of drug applications. For each of the witnesses, you can start, Ms."
Testimony BRADLEY CAMPBELL
Hearings to examine FDA bureaucracy, focusing on regulator to roadbloc...
senate Aging (Special) Committee · Feb 26, 2026
"individual teams or the new reviewer on the team doesn't quite have. So again, I think we have a lot of the tools that we need, we just need to encourage the FDA to use them in the right way, and that's one example we haven't talked about here today where Congress could fund that directly and allow the FDA to make it a much more valuable tool. Thank you. Thank you, Mr. easier? No, is the candid answer, and you know that's underlying all of this, right? So we have created in the United States..."
Testimony SCOTT, RICK
Hearings to examine FDA bureaucracy, focusing on regulator to roadbloc...
senate Aging (Special) Committee · Feb 26, 2026
"that the FDA suggested withdrawing patients from compassionate use care to evaluate whether their conditions would deteriorate, despite physicians expressing the harm would be irreversible. So, tell me about the, what that. Mr. Campbell, talk about inconsistent FDA standards, how it impacts timelines, costs, ability of small biotech companies to survive. Is it easy to raise money if the FDA is inconsistent? Does that make your job Dr. O'Neill, in progressive rare diseases, how should regulators..."
Testimony SPEAKER_38
Lowering Health Care Costs for All Americans: An Examination of the Pr...
house Energy and Commerce Committee · Feb 11, 2026
"The lead in the world, yes, ma'am. Congresswoman, we need a modernized and reformed and bold changes at the FDA, and the core of that has to be the leadership and the staff at FDA. So when you look at the changes that have been made, they've been very difficult, and you've seen reductions in force. FDA, particularly scientific reviewers, medical reviewers, inspectors. That is the core, the gold standard of FDA for our industry in America and around the"
Testimony SCHRIER, KIM
Lowering Health Care Costs for All Americans: An Examination of the Pr...
house Energy and Commerce Committee · Feb 11, 2026
"People with severe allergies carry them around in case they have a life-threatening allergic reaction. EpiPens can cost over $600 out of pocket, and I just want to say that that is for kids who have to have one at home, one at school, every single year, and I want to call on Viatris and all manufacturers of EpiPens to drop the price or we will take congressional action. Turning to vaccines, also a pediatrician, and this administration's war specifically on mRNA vaccines, just yesterday, as Mr...."
Testimony AUCHINCLOSS, JAKE
Lowering Health Care Costs for All Americans: An Examination of the Pr...
house Energy and Commerce Committee · Feb 11, 2026
"career scientists at the agency, builds upon a pattern of replacing safety and efficacy with fear and favor. The commissioner's national priority voucher is unethical, unwise, and illegal. And they have refused now after three letters from me to respond to any of the questions or assertions I've put forward. One former FDA commissioner told me that FDA has hemorrhaged 20 years of competence and credibility in just the last one. And yet we don't have a hearing. When is this committee going to do..."
Testimony SPEAKER_29
Lowering Health Care Costs for All Americans: An Examination of the Pr...
house Energy and Commerce Committee · Feb 11, 2026
"upcoming review capacity and timelines for drug reviews? Give us kind of the lay of the land FDA practices work. So thank you for affirming what I suspected. I appreciate the answers. It's important that the federal government meet the needs of patients by ensuring the FDA is a reliable partner for drug review and approval. Another area I want to touch on is rare diseases. Despite nearly 1 in 10 Americans having a rare disease, only about 5% of the thousands of rare diseases have an..."
Testimony STEPHEN W. SCHONDELMEYER
Hearings to examine truth in drug labeling.
senate Aging (Special) Committee · Jan 29, 2026
"FDA may well have all of this information and other information on quality, but they either aren't authorized or as a matter of policy don't choose to release a lot of it. And so just having the information at FDA doesn't necessarily improve the quality and the ability of decision makers to make decisions, whether it's the consumer or the prescriber or the pharmacist or the purchaser, they need to know what FDA knows to make those decisions. So made by or product of, and API product of,..."
Testimony JOHN GRAY
Hearings to examine truth in drug labeling.
senate Aging (Special) Committee · Jan 29, 2026
"And then I agree with the searchable data, the easy-to-access database that includes more details on that, and also, as I mentioned in my testimony, quality ratings. I'll just say quickly, hopefully this will sort of answer your question, that FDA has requested authorization to be able to release a bunch of manufacturing location, API, active ingredient, API, finished dosage form, excipients, critical excipients, et cetera, allowing them to do that. The FDA feels bounded to not be able to do..."
Testimony STEPHEN W. SCHONDELMEYER
Hearings to examine truth in drug labeling.
senate Aging (Special) Committee · Jan 29, 2026
"If you take that, that's probably 70 or 80 percent of the world's global supply, so it really is the same system. We need a system equivalent to, and we need to, I applaud FDA and the DailyMed website that's maintained, but it's not nearly as consumer-friendly as New Zealand's system is, and we need to look at, emulate their process, and then make transparent the information that FDA does have. I believe it"
Hearing Full Committee Markup of 16 Bills
house Energy and Commerce Committee · May 21, 2026 · Transcript · 2 transcript matches
BILIRAKIS, GUS M. "including clinical trial enrollment, safety reporting, and the use of small patient population data to support future approvals. It also strengthens oversight by requiring an updated FDA action plan and additional reporting on FDA's progress. Importantly, this legislation recognizes that advances made in ALS research may also help patients living with other rare neurodegenerative diseases. While there is still much work to be done, continuing to support research, innovation, and access to promising therapies offers hope to patients and families confronting these devastating diseases every..."
Hearing H.R.4398, the “Veteran Burial Timeliness and Death Certificate Accountability Act”; H.R.4805, the “Warrior Impact from Neurological and G-Force...
house Health Subcommittee · Jun 30, 2026 · Transcript
CONAWAY, HERBERT C. "Within the VA system? And just, and so it's an advice that has been approved by the FDA for a particular clinical use that we're, this was not an experimental device, it was one that was already approved by FDA or? I"
Hearing Business meeting to consider S.1782, to prohibit discrimination on the basis of mental or physical disability in cases of organ transplants,...
senate Health, Education, Labor, and Pensions Committee · Jun 17, 2026 · Transcript
COLLINS, SUSAN M. "works. It increases competition from generic drugs through better oversight of the FDA citizen petition process. Brand name manufacturers were behind roughly 86% of all citizen petitions filed between 2016 and 2019. Overwhelmingly, these petitions did not raise legitimate safety concerns, which is why the FDA rejected more than 9 out of 10 of these petitions. Despite the low success rate, petitions are still able to delay generic drug entry and can unfairly consume FDA resources. Our bipartisan bill would strengthen the FDA's ability to reject citizen petitions if it believes that"
Hearing Hearings to examine advancing the mission, focusing on evaluating the future of VA research.
senate Veterans' Affairs Committee · Jul 22, 2026 · Transcript
MORAN, JERRY "I want to thank our witnesses for being here this afternoon. Last year, the VA Research celebrated its centennial anniversary. Over the last 100 years, the VA's research has revolutionized medicine worldwide from the first successful cardiac pacemaker implantation in 1960 to pioneering the internationally recognized standard for grading prostate cancer with the Gleason score. These historic advancements continue to transform not only the day-to-day lives of millions of veterans, but they benefit civilians as well. In 2016, the VA entered into a partnership with the Prostate Cancer Foundation,..."
Testimony CASSIDY, BILL
Business meeting to consider S.2355, to amend the Public Health Servic...
senate Health, Education, Labor, and Pensions Committee · Jul 22, 2026
"treatments by eliminating costly and redundant clinical study requirements. The manager's amendment includes a policy from Senator Moody to eliminate government red tape that slows down FDA's review of biosimilars. The Insulin Act, sponsored by Senators Collins and Shaheen, caps how much patients pay for insulin, preserving access for the 40 million Americans with diabetes. And the National Plan for Epilepsy Act, led by Senators Schmidt and Klobuchar, will help the 3.4 million Americans living..."
Testimony CASSIDY, BILL
Business meeting to consider S.2355, to amend the Public Health Servic...
senate Health, Education, Labor, and Pensions Committee · Jul 22, 2026
"areas. The Safe Drugs Act, championed by Senators Banks and Heinrich, and the Clear Labels Act from Senators Rick Scott and Gillibrand, include common-sense policies to help patients understand what is in their drugs, whether they are compounded by the pharmacy down the street, or manufactured at a manufacturing plant, and help FDA and states better track when a problem occurs. The Making Families' Food Safer Act, from Senator Tuberville, gives food safety regulators the ability to better..."
Testimony SANDERS, BERNARD
Business meeting to consider S.2355, to amend the Public Health Servic...
senate Health, Education, Labor, and Pensions Committee · Jul 22, 2026
"a piece that I introduced called the Childhood Diabetes Reduction Act. This legislation will require the FDA to put strong warning labels on ultra-processed foods that are high in sugar, salt, and saturated fats. Importantly, it would also ban junk food ads targeted to children, similar to what Congress did to the tobacco industry nearly 30 years ago. Mr. Chairman, in America today, we have an obesity epidemic and a diabetes"
Testimony SANDERS, BERNARD
Business meeting to consider S.2355, to amend the Public Health Servic...
senate Health, Education, Labor, and Pensions Committee · Jul 22, 2026
"How has it happened that over 40% of adults in our country today are obese? And in my view, the answers to these questions are not very complicated. For decades, Congress and the FDA have allowed large corporations to make huge profits by enticing children and adults to consume ultra-processed food and beverages loaded up with sugar, salt, and saturated fat. We can begin to turn that around today by passing this"
Testimony SANDERS, BERNARD
Business meeting to consider S.2355, to amend the Public Health Servic...
senate Health, Education, Labor, and Pensions Committee · Jul 22, 2026
"15 teaspoons of sugar, over twice the recommended daily limit for kids. Given this reality, which has been widely discussed by scientists and doctors for decades, the question then arises, what has the FDA done to address these epidemics, which have impacted the health of millions of Americans and cost us hundreds of billions every year? The answer is, not much. So, Mr. Chairman, under the bill that we are now considering, the FDA would be required to put a warning label on sugary drinks that..."
Testimony CASSIDY, BILL
Business meeting to consider S.2355, to amend the Public Health Servic...
senate Health, Education, Labor, and Pensions Committee · Jul 22, 2026
"In the 15 years since the biosimilar regulatory framework was created, we've learned a lot about how to ensure they are safe and work for patients, but laws have not kept up. This bill addresses these problems by reducing data required under law that in many cases is unnecessary, and it aligns with the FDA's common practice to provide clearer rules for biosimilar developers. It establishes a clear, consistent process for when FDA needs to require additional studies. It establishes a clear,..."
Testimony KEVIN OUTTERSON
Hearings to examine building a resilient health care future with biote...
senate Finance Committee · Aug 4, 2026
"Antibiotics are valuable, but the economic market is really undeniably broken. FDA approval should be a celebration for these companies. They should pop up as a quirk and celebrate, but the payday never comes for"
Testimony KEVIN OUTTERSON
Hearings to examine building a resilient health care future with biote...
senate Finance Committee · Aug 4, 2026
"And by that time, many of these companies have gone bust. We've had 11 small companies bring in a new FDA-approved antibiotic to the market in the last decade."
Testimony KEVIN OUTTERSON
Hearings to examine building a resilient health care future with biote...
senate Finance Committee · Aug 4, 2026
"Their R&D investors completely wiped out. That's 100% of the small companies with FDA approvals for antibiotics in the last decade. We need a better pipeline of these critical"
Testimony CASSIDY, BILL
Hearings to examine building a resilient health care future with biote...
senate Finance Committee · Aug 4, 2026
"Yeah, something – Secondly, as regards – I had somebody who had a superior product for detecting colon cancer. They got through FDA. They couldn't get a CPT code. And so that 18-month delay – in their case, it may have been longer, I forget – between getting FDA approval and getting a CPT code could really be life or death for a company trying to make it. Any comments on that and the importance of getting a tighter coordination and a shorter timeframe between FDA approval and getting a CPT"
Testimony KEVIN OUTTERSON
Hearings to examine building a resilient health care future with biote...
senate Finance Committee · Aug 4, 2026
"Well, right now we've had four projects in which we've looked at bacteriophage, which is a virus that eats bacteria, literally. We've pioneered some of the early work on microbiome research, and two projects are now approved by the FDA. We've looked at 35 small molecule chemical classes, all of them never before approved for FDA products, so lots of new, entirely new things that are coming through the pipeline. We've looked at 35 small molecule chemical classes, all of them never before..."
Testimony JOHNSON, RON
Hearings to examine the testimony of Anthony Fauci.
senate Homeland Security and Governmental Affairs Committee · Jul 29, 2026
"that. And I'll ask this question. Were you ever made aware of the fact that Peter Marks was warned that the algorithm was going to hide the safety signals? And were you told that senior FDA officials were given dozens, shown dozens of safety signals associated through is in that same month of March 2021, an employee at NIH, Dr. Nath, was diagnosed an employee at NIH, Dr. Nath, led a team of researchers who were"
Testimony JOHNSON, RON
Hearings to examine the testimony of Anthony Fauci.
senate Homeland Security and Governmental Affairs Committee · Jul 29, 2026
"I referred them to doctors who actually had the courage and compassion to treat vaccine-injured individuals, it works. But I was going to ask you, whether you were involved in the FDA attack on ivermectin. You had a interview on CNN on August 29th of"
Testimony HASSAN, MARGARET WOOD
Hearings to examine the testimony of Anthony Fauci.
senate Homeland Security and Governmental Affairs Committee · Jul 29, 2026
"and the outbreak is nowhere near under control, as staffing at the FDA and other critical public health entities has been slashed by Russell Vogt and Elon Musk. Last year, the National Institutes of Health awarded, I think it's 201 fewer"
Testimony JOHNSON, RON
Hearings to examine the testimony of Anthony Fauci.
senate Homeland Security and Governmental Affairs Committee · Jul 29, 2026
"These are average, again, AVAERS doesn't prove causation, but, you know, there's correlation. It's there for a safety signal. So, ivermectin, over 30 years of FDA reports, 17 deaths per year. Hydroxychloroquine, over 38 years of reporting, 142 deaths per year. Remdesivir,"
Testimony JOHNSON, RON
Hearings to examine the testimony of Anthony Fauci.
senate Homeland Security and Governmental Affairs Committee · Jul 29, 2026
"five and a half years, 546 deaths per year. The COVID injection, almost 7,000 deaths per year. Which is safest? What did the FDA freak us out about? Ivermectin, hydroxychloroquine, when they turn a complete blind's eye toward the injection's injury. So, I want to enter the quote from the surgeon. By the way, here's the answer. Cheryl Atkinson, in an"
Testimony JOHNSON, RON
Hearings to examine the testimony of Anthony Fauci.
senate Homeland Security and Governmental Affairs Committee · Jul 29, 2026
"Dr. Weissman replies, he said, we still have some concerns over the data after they tested at IM. Now, again, there's more documentation in terms of the FDA blew it off. It's like, don't worry about that. That was the whole"
Testimony JOHNSON, RON
Hearings to examine the testimony of Anthony Fauci.
senate Homeland Security and Governmental Affairs Committee · Jul 29, 2026
"based quite honestly on our investigation into the cover-up of safety signals and injection injuries, we have issued letters to a number of former FDA officials to come in for transcribed interviews. You will be getting a letter today asking for a volunteer transcribed interview. So I'd be asking will you comply or will I have to subpoena"
Testimony DR. JEFFERY TALBERT
“Building an AI-Ready America: How AI Is Creating Opportunities Across...
house Education and Workforce Committee · Jul 24, 2026
"Deep learning models have been shown to predict acute kidney injury up to 48 hours before traditional clinical recognition. FDA-cleared AI systems for diabetic retinopathy can identify patients at risk for preventable blindness in primary care settings, allowing interventions before disease progression. We are also beginning to see AI accelerate the development of new"
Testimony DR. JEFFERY TALBERT
“Building an AI-Ready America: How AI Is Creating Opportunities Across...
house Education and Workforce Committee · Jul 24, 2026
"A couple of distinctions I'll make to kind of respond to, I think, the keynote of your question, which is how competent is the AI that we're using in healthcare. And the first thing to note is that the FDA actually right now regulates about, I think they have 1,450 approved AI tools. Those have been around, the first ones were approved in the late 1990s. And so these are, anytime you go and have an MRI, a CT scan, or an x-ray, the radiologist that reads that, and the machine that actually does..."
Testimony MORAN, JERRY
Hearings to examine advancing the mission, focusing on evaluating the ...
senate Veterans' Affairs Committee · Jul 22, 2026
"I want to thank our witnesses for being here this afternoon. Last year, the VA Research celebrated its centennial anniversary. Over the last 100 years, the VA's research has revolutionized medicine worldwide from the first successful cardiac pacemaker implantation in 1960 to pioneering the internationally recognized standard for grading prostate cancer with the Gleason score. These historic advancements continue to transform not only the day-to-day lives of millions of veterans, but they..."