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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 · 65 transcript matches
VEASEY, MARC A. "At the same time, I think especially we learned a lot of this lesson around COVID-19, making sure that we ensure that clinical research reflects the diversity of the population that we have here and who's ultimately going to use these therapies is going to be very critical to generating evidence that is both scientifically robust and applicable. Dr. Verse, given your experience designing and implementing these clinical trials across a wide array, how can Congress ensure that efforts to modernize clinical trials also expand participation amongst historically underrepresented communities,..."
Hearing Hearings to examine behind the label, focusing on foreign ownership and control in America's drug supply chain.
senate Aging (Special) Committee · Jul 15, 2026 · Transcript · 12 transcript matches
STEPHEN EZELL "China now accounts for 31% of the new drug development pipeline globally. China has surpassed the US now in clinical trial starts for new oncology drugs. And overall, their share of ongoing clinical trials for new drugs, the most innovative ones in the world, is now just 3% off the US share. China has deployed every policy lever conceivable to turbocharge its biopharmaceutical competitiveness. To be sure, some of these are legitimate, such as increasing R&D investment, educating scientists, reforming clinical trial"
Hearing Hearings to examine advancing the mission, focusing on evaluating the future of VA research.
senate Veterans' Affairs Committee · Jul 22, 2026 · Transcript · 10 transcript matches
MURRAY, PATTY "all VA research staff became subject to a hiring freeze and probationary firings. As a result, research at the Pittsburgh VA to predict stroke risk was put on hold. Enrollment into clinical trials for advanced cancer was delayed, and a clinical trial in Florida on preventing dementia and heart disease was canceled. And, Mr. Chairman, I could go on. I've heard a lot of stories like that, and so I'm deeply concerned. In addition, the department also enforced vacancy cuts and staffing caps on its facilities. Though those cuts technically exclude research staff, a study at a VA site in the..."
Hearing Hearings to examine building a resilient health care future with biotechnology.
senate Health Care Subcommittee · Aug 4, 2026 · Transcript · 5 transcript matches
VERA P. LUTHER "To save patients' lives and protect modern medical care, we need three things. We need novel antimicrobial drugs, stewardship programs to improve antimicrobial use, and infectious disease physicians to treat patients with resistant infections, lead clinical trials, and lead health systems programs to prevent these"
CRS Report
Testing, Testing, (Phase) 1-2-3: Legal Considerations for Clinical Trials of Potential COVID-19 Vaccines
Posts · Jun 2, 2020
In the race to develop a Coronavirus Disease 2019 (COVID-19) vaccine, several pharmaceutical companies, governments, and educational institutions around the world have begun testing their potential...
CRS Report
Expanded Access and Right to Try: Access to Investigational Drugs
Reports · Mar 16, 2021
The Food and Drug Administration (FDA) regulates the safety and effectiveness of drugs and biological products under its authorities in the Federal Food, Drug and Cosmetic Act (FFDCA) and Public...
CRS Report
Legal Issues in COVID-19 Vaccine Development and Deployment
Reports · Nov 25, 2020
Private companies, universities, and governmental entities are working to develop a vaccine for coronavirus disease 2019 (COVID-19). Vaccines are biological products regulated under the Public Health...
Testimony MURRAY, PATTY
Hearings to examine advancing the mission, focusing on evaluating the ...
senate Veterans' Affairs Committee · Jul 22, 2026
"all VA research staff became subject to a hiring freeze and probationary firings. As a result, research at the Pittsburgh VA to predict stroke risk was put on hold. Enrollment into clinical trials for advanced cancer was delayed, and a clinical trial in Florida on preventing dementia and heart disease was canceled. And, Mr. Chairman, I could go on. I've heard a lot of stories like that, and so I'm deeply concerned. In addition, the department also enforced vacancy cuts and staffing caps on its..."
Testimony ANNIE KENNEDY
Hearings to examine FDA bureaucracy, focusing on regulator to roadbloc...
senate Aging (Special) Committee · Feb 26, 2026
"expertise and manufacturing expertise that are not always internal to the agency, to be brought to bear on regulatory decisions, because we realize that with 10,000 rare diseases, it is not possible for FDA to always have all of that expertise internal. Those committee hearings must be at the avail of the agency, but also those open public hearings must be available so that patient communities who are participating in clinical trials can share what their experiences in those clinical trials..."
Testimony STEPHEN EZELL
Hearings to examine behind the label, focusing on foreign ownership an...
senate Aging (Special) Committee · Jul 15, 2026
"China now accounts for 31% of the new drug development pipeline globally. China has surpassed the US now in clinical trial starts for new oncology drugs. And overall, their share of ongoing clinical trials for new drugs, the most innovative ones in the world, is now just 3% off the US share. China has deployed every policy lever conceivable to turbocharge its biopharmaceutical competitiveness. To be sure, some of these are legitimate, such as increasing R&D investment, educating scientists,..."
Testimony VEASEY, MARC A.
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"At the same time, I think especially we learned a lot of this lesson around COVID-19, making sure that we ensure that clinical research reflects the diversity of the population that we have here and who's ultimately going to use these therapies is going to be very critical to generating evidence that is both scientifically robust and applicable. Dr. Verse, given your experience designing and implementing these clinical trials across a wide array, how can Congress ensure that efforts to..."
Testimony SPEAKER_03
Full Committee Markup of 16 Bills
house Energy and Commerce Committee · May 21, 2026
"And public opinion research suggests that Americans would support up to 7% of GDP being spent on basic research. So there's broad-based popular support for more research and discovery funding. I think we should also expand throughput of clinical trials in this country, because Alzheimer's disease is a very expensive disease to put through clinical trials, because the endpoints the endpoints and the proxies are challenging to discern and because the disease can progress slowly and unevenly. And..."
Testimony DR. CYNTHIA VERST
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"Beginning as Dr. Winkler, I give you an honorary degree, mentioned in terms of the academic medical centers are critically important, but so are the hub and spoke referral methodologies. If we're able to put the right technology systems in place within healthcare systems, EMR technology that can be interoperable with electronic data capture associated with clinical trials, one would then be able to identify the right patient at the right time on their clinical journey to be eligible for certain..."
Testimony RUIZ, RAUL
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"Thank you so much. We must first and foremost ensure the effectiveness and the safety of new innovations during the clinical trial process. That's ground zero. And as an emergency physician, I'm concerned about the potential effects that the lack of participation in clinical trials may have on the effectiveness of new medical treatments and therapies for populations that are underrepresented in these clinical trials, okay? So many barriers prevent patients from participating in clinical trials,..."
Testimony DR. CYNTHIA VERST
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"in orientation in terms of the predominance of the biotech sector. But in addition, 65% of Phase I through III clinical trials globally are actually conducted and invested by this It's a terrific question and certainly a challenge on the clinical trial front. I think that first and foremost, understanding how to recruit and incentivize community physicians to participate in clinical trials. Of course, it's incumbent upon us as an industry to ensure that we reduce the burden in"
Testimony GUTHRIE, BRETT
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"So Dr. Kowalski, in Breakthrough T1D, you've worked closely with FDA and product developers to advance all the innovative clinical designs and trials with endpoint development for therapies and ultimately to benefit patients with type 1 diabetes. Can you describe how early collaboration between the FDA sponsors and patient organization contributed to that success and what lessons can Okay, thank you. And so, Dr. Verst, we've heard increasing concerns that other countries are reducing the time..."
Testimony AUCHINCLOSS, JAKE
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"What are key considerations for Congress to support FDA consistency and transparency in trial design, accepted endpoints, and natural history studies while maintaining a flexible regulatory environment? Part of it, Congress can legislate, and we should, and our bill really focuses on the and our bill really focuses on the things that only Congress can do, particularly creating a point-of-care clinical trial enrollment process, because only maybe 5% to 7% of eligible U.S. patients are enrolled..."
Testimony GILLIBRAND, KIRSTEN E.
Hearings to examine FDA bureaucracy, focusing on regulator to roadbloc...
senate Aging (Special) Committee · Feb 26, 2026
"science challenges that are unique in rare disease therapy development and review. Like designing complex clinical trials, developing appropriate endpoints, and using real world evidence. But it's not working how it should be. FDA's approach, transparency, and flexibility varies widely between its offices, divisions, and centers. We've seen a pattern of hesitation to use authorized flexibilities, limited communication with drug sponsors, failure to incorporate patient experience and real world..."
Testimony GILLIBRAND, KIRSTEN E.
Hearings to examine behind the label, focusing on foreign ownership an...
senate Aging (Special) Committee · Jul 15, 2026
"generic drugs. Congress must work with industry to make sure manufacturers and purchasers consider quality, not just cost, when they source key pharmaceutical ingredients and final dose medicines. Foreign countries like China have rapidly scaled up innovation for novel therapies through efforts like clinical trial reform, targeted government investment in drug development, and improved coordination between early research and commercial scale manufacturing. While we do not need to replicate the..."
CRS Report
COVID-19: Legal Considerations for Bringing a New Vaccine to Market
Posts · Mar 24, 2020
As the number of confirmed COVID-19 cases increases at an accelerating rate, interest has grown in developing a COVID-19 vaccine as an avenue for addressing the pandemic. Media reports indicate that...
Hearing Hearings to examine FDA bureaucracy, focusing on regulator to roadblock.
senate Aging (Special) Committee · Feb 26, 2026 · Transcript · 4 transcript matches
ANNIE KENNEDY "expertise and manufacturing expertise that are not always internal to the agency, to be brought to bear on regulatory decisions, because we realize that with 10,000 rare diseases, it is not possible for FDA to always have all of that expertise internal. Those committee hearings must be at the avail of the agency, but also those open public hearings must be available so that patient communities who are participating in clinical trials can share what their experiences in those clinical trials are. One of the challenges we have in clinical trial design is we don't always know what we're going to..."
CRS Report
The Pharmaceutical Drug Development Process
Infographics · May 29, 2019
/ THE PHARMACEUTICAL DRUG DEVELOPMENT PROCESS The pharmaceutical drug development process includes three stages: research and development (R&D), approval, and postmarketing. On average, drugs take...
CRS Report
Federal “Right-to-Try” Legislation: Legal Considerations
Posts · Mar 30, 2018
Congress has been engaged in a vigorous debate over how patients with life-threatening conditions may access investigational therapies that have not been approved under the Federal Food, Drug, and...
CRS Report
Vaccine Safety in the United States: Overview and Considerations for COVID-19 Vaccines
Reports · Jan 29, 2021
Widespread immunization efforts have been linked to increased life expectancy and reduced illness. U.S. vaccination programs, headed by the Centers for Disease Control and Prevention (CDC) within the...
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
Off-Label Use of Prescription Drugs
Reports · Feb 23, 2021
When the Food and Drug Administration (FDA) approves a drug for sale in the United States, the approval includes a section entitled “Indications for Use.” This section lists the one or more diseases,...
CRS Report
The Role of Patents and Regulatory Exclusivities in Drug Pricing
Reports · Jan 30, 2024
Intellectual property (IP) rights play an important role in the development and pricing of prescription drugs and biologics. To encourage innovation, IP law grants inventors exclusive rights in a...
Testimony DR. MARK ZHANG
Hearings to examine advancing the mission, focusing on evaluating the ...
senate Veterans' Affairs Committee · Jul 22, 2026
"VA also continues to lead research on toxic exposures, including burn pits and Agent Orange, and on traumatic brain injury and blast overpressure, following large veteran cohorts to develop next-generation brain health biomarkers and conducting a national clinical trial for mild TBI treatment. Looking ahead, our strategy is built on three priorities—expanding access to high-quality clinical trials, delivering real-world clinical impact, and leveraging VA's data for veterans' Looking ahead, our..."
CRS Report
The U.S. Blood Supply and the COVID-19 Response: In Brief
Reports · Aug 26, 2020
The nation’s blood supply is largely managed by a network of independent blood centers and the American Red Cross, with some oversight from the Department of Health and Human Services (HHS) and the...
Testimony DR. AARON KOWALSKI
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"inaccessible for research and transplantation because FDA regulates them as drugs instead of organs. Clinical trials are another challenge. C-peptide, for example, is the best, simplest measure of your body's insulin production. Yet in clinical trials, FDA hasn't granted full approval for using C-peptide as an endpoint. C-peptide, for example, is the best, simplest measure of your body's insulin production. Yet in clinical trials, FDA hasn't granted full approval for using C-peptide as an..."
Testimony MR. THOMAS BOLLYKY
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"Thank you for the excellent question. So part of it is a decline in U.S. competitiveness, not just vis-a-vis China for early-stage clinical trials, but also Australia and other markets as well. It is a cumbersome, burdensome process under the IND approach, and that has helped encourage activity to go abroad. But make no mistake, China's rise in this area is not just simply a matter of market forces. It is decades of coordinated state intervention and investment. And while it's critical, as many..."
CRS Report
Medical Product Regulation: Drugs, Biologics, and Devices
Resources · May 26, 2023
The Food and Drug Administration (FDA) regulates the safety and effectiveness of drugs, biologics, and devices (“medical products”) pursuant to its authorities under the Federal Food, Drug and...
Testimony KEAN, THOMAS H.
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"that more certainty. Thank you. Thank you. Ms. Winkler, in your testimony you stressed the importance of doing more with less, which is critical for the development of oncology and rare disease products where trials are costly and it's difficult to find patients. First, how can the FDA support modernizing clinical trial designs and structures to allow for more patient access to trials? There are a couple And second, how can Congress strengthen FDA's ability in this through the user"
Testimony MURRAY, PATTY
Hearings to examine advancing the mission, focusing on evaluating the ...
senate Veterans' Affairs Committee · Jul 22, 2026
"Those delays are partially due to a wildly inefficient hiring process for VA research staff. Researchers are reporting to us that the time to hire a new member of their staff now often takes up to six months. As a result, a planned study on RSV missed its enrollment window and could not even enroll participants. Another clinical trial closed after it took six months to hire a researcher. The study's principal investigator and its lead clinician both resigned from the VA after that debacle. VA..."
Testimony DR. MARK ZHANG
Hearings to examine advancing the mission, focusing on evaluating the ...
senate Veterans' Affairs Committee · Jul 22, 2026
"VA has sharpened its research enterprise to prioritize measurable clinical benefit, accountability, and faster translation of discovery into care. This strategy is already producing results. We have grown the cancer clinical and research network to more than 100 VA medical facilities, giving veterans access to cutting-edge clinical trials closer to home. Our Lung Cancer Precision Oncology Program has delivered more than 1 million lung cancer screening scans, helping identify cancers earlier..."
Testimony GINA CARITHERS
Hearings to examine advancing the mission, focusing on evaluating the ...
senate Veterans' Affairs Committee · Jul 22, 2026
"specific to the new treatments for these prostate cancer treatments. We've seen that across this era that we've generated 27 clinical trials that have yielded more than 850 peer-reviewed publications. PopCap's success is"
Testimony GINA CARITHERS
Hearings to examine advancing the mission, focusing on evaluating the ...
senate Veterans' Affairs Committee · Jul 22, 2026
"and dedicated research staff, enabling more veterans to access precision testing, targeted treatments, and clinical trials no matter where they live. Each of our veterans dedicated his life for the safety and freedom of our"
Testimony GINA CARITHERS
Hearings to examine advancing the mission, focusing on evaluating the ...
senate Veterans' Affairs Committee · Jul 22, 2026
"The PopCap Act of 2026 will drive this care, advance clinical trials, and benefit men, the women in their lives, and their families nationwide. It will amplify the impact of private"
Testimony GINA CARITHERS
Hearings to examine advancing the mission, focusing on evaluating the ...
senate Veterans' Affairs Committee · Jul 22, 2026
"And so, yes, our vision is being realized. We're continuing to work with our VA clinical trial organizations across this country. And we're continuing to support their efforts and support their efforts in terms of publications, communication, dissemination of their great research. the clinical trial researchers in these"
Testimony SCOTT, RICK
Hearings to examine behind the label, focusing on foreign ownership an...
senate Aging (Special) Committee · Jul 15, 2026
"but who owns the companies making them. Foreign ownership and control can create leverage over our drug supply that is largely invisible to the federal government. So, there's not a federal agency that's been designed to understand this. FDA doesn't have full visibility into it, and current disclosure rules don't require the transparency needed to even know where the risks are. And it goes even further than that. Most people think about foreign threats to our drug supply in terms of what's on..."
Testimony THE HONORABLE NAZAK NIKAKHTAR
Hearings to examine behind the label, focusing on foreign ownership an...
senate Aging (Special) Committee · Jul 15, 2026
"intentionally keeps prices low and transfers wealth to the Chinese Communist Party, and the CCP uses its cash flow to underprice the rest of the world in biotech goods and services and subsidize their industries at a scale that dwarfs ours. These predatory economic practices These predatory economic practices are along with the well-established reality of pervasive IP theft, as well as clinical trials being conducted in China without any regard to the welfare of the population, is very..."
Testimony STEPHEN EZELL
Hearings to examine behind the label, focusing on foreign ownership an...
senate Aging (Special) Committee · Jul 15, 2026
"But since then, China's growth in the industry has been tremendous as China's value added in this industry has grown from just $15 billion in 2002 to $190 billion by 2024. China seeks dominance across all phases of the biopharmaceutical supply and innovation chain, all the way from the manufacturing of key starting materials, KSMs, and active pharmaceutical ingredients to generic and innovative drugs, in addition to the conduct of the clinical trials and the basic science behind them. We'll..."
Testimony EDWARD YOU
Hearings to examine behind the label, focusing on foreign ownership an...
senate Aging (Special) Committee · Jul 15, 2026
"And Mr. Chairman, you already mentioned about the CAR T-cell therapy issue and the fact that our own FDA has cleared multiple Chinese startups with CAR T-cell therapies. It is a breakthrough cancer treatment. And they are being brought over to the U.S. and being put into U.S. patients and the resulting clinical trial data is then being sent back to China. What that means is that that data is then supercharging their AI to analyze it and come out with the iteration for the next round of..."
Testimony DR. RUSH DOSHI
Hearings to examine behind the label, focusing on foreign ownership an...
senate Aging (Special) Committee · Jul 15, 2026
"Second, we have to strengthen our system. We need to reform our clinical trial process to move faster to first in human trials, drawing perhaps from Australia's model. That will make arbitrage less likely. And we have to fund basic science now more than ever to keep our ecosystem"
Testimony EDWARD YOU
Hearings to examine behind the label, focusing on foreign ownership an...
senate Aging (Special) Committee · Jul 15, 2026
"Biotechnology offers that to them. So you see the full court press and from the whole scope in either funding and research and development, acquiring talent development, right? So we've seen that happen right now, too, looking at the talent going overseas. As was mentioned before, looking at investments that may not necessarily trip the bar, but then also looking at downstream, too, as I mentioned, the standards aspect of it as well is that it's not just about theft of IP, but if you also are..."
Testimony DR. RUSH DOSHI
Hearings to examine behind the label, focusing on foreign ownership an...
senate Aging (Special) Committee · Jul 15, 2026
"That is one enormous manufacturing advantage, but it's perhaps not the most important advantage. What I'm more concerned about right now is the fact that their clinical trial process or their pre-IND investigations are able to move much faster than ours. In China, if you want to get a biologic into a human being, you just go to a hospital and you get a green board. In our country, we have to go through the FDA. The difference in time can be a year. But for a pharma company in America, when they..."
Testimony DR. RUSH DOSHI
Hearings to examine behind the label, focusing on foreign ownership an...
senate Aging (Special) Committee · Jul 15, 2026
"de-risked data. So they're willing to pay a premium for it. And that premium comes at the expense of patient access and quality and other kinds of considerations that we care about, patient rights, for example. But it's still a powerful incentive. Those two forces together mean that China is hollowing out drug discovery while also basically taking biomanufacturing away from the United States. And our solutions, very quickly in the time left, are first, to fix our clinical trial process through..."
Testimony SCOTT, RICK
Hearings to examine behind the label, focusing on foreign ownership an...
senate Aging (Special) Committee · Jul 15, 2026
"Thanks. Mr. Yu, your test bank calls clinical trial data a strategic national asset. American patients take the risk and American regulators authorize the"
Testimony GRIFFITH, H. MORGAN
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"Operation Trialblazer provides a set of initiatives and reforms to modernize and accelerate medical product development, aiming to remove the unnecessary hurdles and ambiguity that sometimes hinders patient access to innovative treatments. Streamlining clinical trial requirements, encouraging use of modern trial designs and real-world evidence where appropriate, and reducing administrative burden can shorten development timelines and lower costs without compromising science or safety. These..."
Testimony GRIFFITH, H. MORGAN
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"and provide greater standardization through the review process. However, there is still more work that can be done, and reauthorization is not limited to just extending the status quo. Reauthorization gives Congress the opportunity to explore and write legislation so we can continue to work to streamline regulatory processes, reduce unnecessary administrative burdens, strengthen communication with product developers, and ensure the agency has the tools it needs to make the best possible use of..."
Testimony DEGETTE, DIANA
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"because I've really worked a lot on biomedical research issues over my career, and I have to I think that I've never seen a more precarious time for the U.S. leadership around the world in biomedical research. The FDA plays a critical role in regulating clinical trials, centering on the safety of trial participants and making sure that trials are asking the right questions. Over the past year and a half, FDA staff has been decimated. Political appointees have been making decisions that should..."
Testimony DEGETTE, DIANA
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"to consistency, and to a focus on good science. This is particularly important for developers trying to get promising medicines into the clinic. And it's also important to our reputation in the world so we can get clinical trials back into the U.S. and stop this brain drain that we've seen going overseas. Innovative researchers will need to trust the"
Testimony GUTHRIE, BRETT
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"to attract biotechnology companies, their clinical trials, and domestic manufacturing. Our ability to develop and manufacture life-saving medicines, vaccines, and other medical products here in the U.S. depends on a strong domestic biotechnology sector and a regulatory environment that supports"
Testimony GUTHRIE, BRETT
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"while preserving FDA's standards for safety and effectiveness. Bringing new therapies to patients requires clinical trials that are efficient and modern, leveraging new digital technologies and novel evidence supported by sound"
Testimony DR. CYNTHIA VERST
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"thousands of investigators to engage patients and deliver high-quality clinical data to global regulators. IQVIA's vantage point today on the U.S. competitiveness is both practical, pragmatic, and data-driven. We help sponsors design and execute global clinical trials, and we see in real time why companies choose one country over another for their trials. So I'd like to share a few insights and data points and recommendations. Firstly, the United States remains the most sought-after market for..."
Testimony MS. SUSAN WINCKLER
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"The insights I offer today result from some of our recent convening activity. Each produced dozens of specific stakeholder-vetted recommendations, many of which offer insight into how the United States can make its own drug discovery and development system faster, clearer, and more capable. We brought together clinical trial sites, research organizations, FDA-regulated industry, patient groups, and regulators to deliberate shared challenges with candor. The resulting recommendations align with..."
Testimony MS. SUSAN WINCKLER
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"The number of trial sites is also declining under financial pressure. In addition to expanding opportunities like the hub and spoke model for clinical trials, it's also an opportunity to reimagine the screening mechanisms for clinical trial participation. it's also an opportunity to reimagine the screening mechanisms for clinical trial participation. Further, harmonizing legal structures regarding permissible incentives and support for clinical trial participants, which can be essential for..."
Testimony DR. THOMAS HWANG
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"We should welcome competition in the global research enterprise, but such competition has to be fair, transparent, and ethically sound. Recently, the FDA has raised questions about data from single-country and non-U.S. clinical trials that may not be generalizable to patients here. For example, these studies may use a suboptimal control group that does not reflect standard of care in the"
Testimony MR. THOMAS BOLLYKY
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"The ability to conduct first-in-human trials quickly and at low cost enables Chinese biotech firms to determine which compounds hit their biological targets, to refine them, leapfrog more slowly-moving U.S. competitors, and to attract vital licensing deals. The results speak for themselves. China's share of global clinical trials starts has risen from 1% in 2009 to 30% in 2024, rivaling the U.S."
Testimony MR. THOMAS BOLLYKY
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"Second, there is a risk to public health if the U.S. capacity to do innovative drug development diminishes and we cannot rapidly produce effective countermeasures in a crisis, as occurred in COVID-19. Third, there's a risk to patient safety because FDA cannot effectively oversee the level of clinical trial activity now occurring in China, which means U.S. patients and healthcare providers may not be able to fully rely on the resulting data. One recent study found that just 20 GCP inspections,..."
Testimony MR. THOMAS BOLLYKY
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"So what should Congress and the FDA do? First, we need to make our own system better by adopting the operational features of other well-regulated nations that have modernized early clinical trial oversight without sacrificing patient safety or scientific"
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 GRIFFITH, H. MORGAN
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"concern or my concern as well, but do they need a nudge from Congress? I'll get an answer from you later and I'll do a written question on that one. Ms. Winkler, you highlighted how trial capacity is currently unevenly distributed across the country with many patients living a long way from the trial site. Welcome to my district. Absolutely. I'm a long way from any place that does that. I mean, people say, well, why don't you just go to Charlottesville? Well, in parts of my district, it's not..."
Testimony MS. SUSAN WINCKLER
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"right, so that you have the really important, but paperwork heavy, responsibilities of the hub thinking about this is how we run trial sites and they hold some of that responsibility for the spoke so that in communities you could have clinical trials available through the clinicians in the community and they'll operate according to the rules and regulations, you know, the oversight of the hub, but it helps structure the mechanism so that you aren't trying to"
Testimony DR. THOMAS HWANG
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"other countries is that public investment in our hospitals and health systems is critical to improving the capacity that they have in running clinical trials and having a centralized network of these institutions that could be centers of excellence could speak to kind of your"
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 MS. SUSAN WINCKLER
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"So there's a few opportunities, but in particular, assuring that the endpoints that we're pursuing, so what the treatments intend to affect, match what patients are looking for. So that's one of the components. And then there's also the important conversation between the product developers and the regulator for what should be measured and how do those clinical trials need to be conducted. There certainly have been a number of those conversations that have taken place. And now, as that work..."
Testimony PALLONE, FRANK
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"sensible security restrictions on Chinese firms. So what does your research show as a reason for clinical trial activity for promising interventions shifting away from the United States to Beijing, China? Thank you. Thank you very much. Thank you, Madam"
Testimony RUIZ, RAUL
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"So, these are barriers that we can and should address. That's why I introduced the Bipartisan Clinical Trial Modernization Act, H.R. 3521, with Representative Pfluger from Texas. Imagine that, a Democrat from California working with a Republican from Texas doing the right thing. So, this bill would improve participation in clinical trials by addressing economic barriers and helping bring trials to underserved areas where the patients are. For the reasons I mentioned earlier, participant..."
Testimony RUIZ, RAUL
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"rural areas across the nation. Given their broad reach, CHCs can bring research closer to where people live and receive care and greatly expand delivery of clinical research to underserved populations. Ms. Winkler, in your written testimony, you talk about a patient-centered approach. So, what role could community-based providers play in improving patient recruitment and accelerating research, and how would bringing clinical trials into the community care settings change the way patients access..."
Testimony MS. SUSAN WINCKLER
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"the inconsistencies are explained and provided in context? So one of the challenges in clinical trial recruitment is that patients may not be asked, and they're not asked because their local community provider does not have the information about what trial might be appropriate, might be helpful for"
Testimony RUIZ, RAUL
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"Ms. Winkler, in your written testimony, you talk about a patient-centered approach. So, what role could community-based providers play in improving patient recruitment and accelerating research, and how would bringing clinical trials into the community care settings change the way patients access innovative therapies? You know, currently, clinical trials remain concentrated in a small number of academic medical centers, which slows recruitment, narrows the range of data that trial sponsors can..."
Testimony DR. CYNTHIA VERST
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"and of course, incentivizing as appropriate, and using technologies that actually e-sourcing, for instance, EMR and EDC systems being interconnected to simplify the process, and identifying the right patient for the right clinical trial at the right time on his or her patient journey. And of course, this all is working across the healthcare ecosystem in order to be"
Testimony KELLY, ROBIN L.
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"In 2022, along with my colleague, Representative Eshoo, I pushed forward clinical trial diversity standards at the FDA, passed through the Food and Drug Omnibus Reform Act. These standards raise the bar for new FDA applications to submit a plan to improve the enrollment of clinically relevant"
Testimony KELLY, ROBIN L.
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"risk failing to identify potential differences in therapy efficacy or safety. Can you tell us about the role of diversity in clinical trials and the safety and efficacy of biomedical treatment development? Thank you so"
Testimony DR. CYNTHIA VERST
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"so starting with the end in mind for that good science. And that also equates to operationalization of clinical trials. Understanding, for"
Testimony KELLY, ROBIN L.
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"Thank you so much. Dr. Kowalski, can you discuss the importance of clinical trial diversity for participants with type 1 diabetes? Thank you so much, and actually, my"
Testimony KELLY, ROBIN L.
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"and then 4,500 farms as you go further south. So, rural is very, very important to me also. Proper representation in clinical trials ensures that everyone can be confident that treatments are safe and effective. As I continue to fight for critical diversity standards through the NIH Clinical Trial Integrity Act, I urge the FDA to finalize the diversity action plan guidance to the standard mandated by the Food and Drug Omnibus Reform Act of 2022, and Mr. Chairman, I yield"
Testimony DR. CYNTHIA VERST
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"but that adjacency will be critical, especially, for instance, we talked about today, community-based practitioners becoming more integral into clinical trials here in the U.S. And I'll just give a few data points. Oncology is the world's largest clinical trial market. Over 40 to 50% of the entire global clinical trials resides within oncology. Oncology clinical trial investigator capacity is being taxed, especially, as stated, more of the academic medical centers. volume of clinical trials..."
Testimony CARTER, EARL L. "BUDDY"
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"our leadership to China? Okay, well, let's do kind of shift gears a little bit and talk about the clinical trials, because we talked about a little bit up here about decentralizing it, and that's something that I really do think is, can be beneficial, particularly in using all the healthcare facilities that are available. It was mentioned"
Testimony CAMMACK, KAT
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"So obviously there's a little bit of a dispute in who's leading, but I don't think at this point we're going to argue about that. But talk about the importance of this leadership and maintaining dominance in this space. That means that we not only accelerate the development of new therapies, but ensuring that we have a regulatory framework that inspires confidence, that strengthens our domestic research ecosystem and expands opportunities for Americans to participate in clinical trials. And as..."
Testimony MR. THOMAS BOLLYKY
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"A terrific question. Thank you for it. The FDA adopts a risk-based standard to conducting its good clinical practice inspections. It's hard to square a risk-based approach with where those inspections are happening currently. China, the number of trial or inspections we're conducting in China not only is dwarfed by the number of inspections we do in the U.S., it's also true for Japan and Europe. China has a number of fewer inspections in that environment. Congress should consider instituting a..."
Testimony CAMMACK, KAT
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"And you would agree that we need to continue to develop the incentives for more early-stage drug A thousand percent agree. Thank you. Dr. Winkler, I'd like to shift to another opportunity for reform. Where are you? There you are. So women have historically been underrepresented in many clinical trials, if not most, particularly where there are therapies that are ultimately intended for both men and women. So while we've seen some progress, it's not near enough. I want to look towards how the..."
Testimony MS. SUSAN WINCKLER
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"the barriers and what sex-based differences need to be explored, not only scientifically, but practically, in getting then the right mix of participants in the clinical trial. So it requires intentionality. And then also looking at things, are there opportunities to explore some of these post-market, right, what needs to be done pre-marketing, and then what might be explored and better understood after a product is already on the market. So using real-world data to generate real-world evidence..."
Testimony MR. THOMAS BOLLYKY
Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role ...
house Energy and Commerce Committee · Jul 15, 2026
"development here domestically? Absolutely. It really does need to be a combination of making the U.S. competitive and also having better oversight over the activity occurring in China. For both the conversation we're having around clinical trial oversight and attracting more activity, as well as ensuring public health in the U.S., we need a robust FDA appropriately staffed If we're going to compete with other countries, especially China and biomedical innovation, we need to have the expertise..."
Testimony VERA P. LUTHER
Hearings to examine building a resilient health care future with biote...
senate Finance Committee · Aug 4, 2026
"To save patients' lives and protect modern medical care, we need three things. We need novel antimicrobial drugs, stewardship programs to improve antimicrobial use, and infectious disease physicians to treat patients with resistant infections, lead clinical trials, and lead health systems programs to prevent these"
Testimony KEVIN OUTTERSON
Hearings to examine building a resilient health care future with biote...
senate Finance Committee · Aug 4, 2026
"which is a tool created by BARDA to drive innovation in the antimicrobial space. A recent Harvard study found that CARB-X-supported projects actually are moving into human clinical trials and being translated with great success, and I'm grateful for the opportunity to be here today and to talk with you. Americans and their health systems, all of us, rely on effective antibiotics as health care"
Testimony ALAN D. PALKOWITZ
Hearings to examine building a resilient health care future with biote...
senate Finance Committee · Aug 4, 2026
"One is we need to make sure that the science is ready to move forward and translate. So that is really where the infrastructure of the universities, the federally funded programs have really matured science to the point where we can begin to think about that next step in connecting science to patient impact and value creation. But we also need to make sure the right resources are available, the right expertise. We need to make sure that the translational expertise, which is different from what..."
Testimony HASSAN, MARGARET WOOD
Hearings to examine building a resilient health care future with biote...
senate Finance Committee · Aug 4, 2026
"Dr. Palkowitz, small biotechnology companies face significant obstacles when developing new antibiotics. Antibiotic research involves costly early-stage scientific research as well as clinical trials that are more complex than other types of trials because of the urgent and life-threatening nature of infections. I've been working on draft legislation that would give biotechnology companies bigger tax incentives to develop new antibiotics and help patients who get superbug"
Testimony KEVIN OUTTERSON
Hearings to examine building a resilient health care future with biote...
senate Finance Committee · Aug 4, 2026
"About a third of our funding comes from the U.S. government today, and the balance from the G7 governments and large foundations. The key is to de-risk the technology so that it can get into human clinical trials and you can get across the valley of death, whatnot, and to do that in a way that is looking for the most innovative, interesting technology out there. Well, right now we've had four projects in which we've looked at bacteriophage, which is a virus that eats bacteria,"
Testimony HASSAN, MARGARET WOOD
Hearings to examine the testimony of Anthony Fauci.
senate Homeland Security and Governmental Affairs Committee · Jul 29, 2026
"especially at the beginning of the Trump administration, I can tell you, I can tell my colleagues what the impact was on people in New Hampshire, on scientists in New Hampshire, on clinical trials in New Hampshire, where people's cancer treatment was interrupted because Elon Musk and Russell Vogt know"
Testimony DR. JEFFERY TALBERT
“Building an AI-Ready America: How AI Is Creating Opportunities Across...
house Education and Workforce Committee · Jul 24, 2026
"The approval process for that goes through something very similar to medications. So to get a medication approved, you know, it has to go through the clinical trial process and to be approved. So the AI tools go through the same process, or a very similar process that those drugs go"
Testimony SMITH, TINA
Hearings to examine the Consumer Financial Protection Bureau Semi-Annu...
senate Banking, Housing, and Urban Affairs Committee · Jul 16, 2026
"So the clear feeling amongst folks in my home state is that what's happening is that there is a political screen that is being imposed on grants. And here's an example of one of these situations. One of my constituents in Minnesota was participating in an NIH-funded clinical trial to treat stomach cancer. The trial was canceled, unexpectedly halted. This person never received their surgery. And the trial never"
CRS Report
The National Institutes of Health (NIH): Background and Congressional Issues
Reports · Jan 13, 2025
The National Institutes of Health (NIH), under the Department of Health and Human Services (HHS), is the leading federal agency for biomedical and health research. In FY2024, NIH used its over $47...
Hearing Full Committee Markup of 16 Bills
house Energy and Commerce Committee · May 21, 2026 · Transcript
SPEAKER_03 "And public opinion research suggests that Americans would support up to 7% of GDP being spent on basic research. So there's broad-based popular support for more research and discovery funding. I think we should also expand throughput of clinical trials in this country, because Alzheimer's disease is a very expensive disease to put through clinical trials, because the endpoints the endpoints and the proxies are challenging to discern and because the disease can progress slowly and unevenly. And so getting more shots on goal through better, faster, cheaper clinical trials makes a cure come even..."
Hearing Hearings to examine the testimony of Anthony Fauci.
senate Homeland Security and Governmental Affairs Committee · Jul 29, 2026 · Transcript
HASSAN, MARGARET WOOD "especially at the beginning of the Trump administration, I can tell you, I can tell my colleagues what the impact was on people in New Hampshire, on scientists in New Hampshire, on clinical trials in New Hampshire, where people's cancer treatment was interrupted because Elon Musk and Russell Vogt know"
Hearing “Building an AI-Ready America: How AI Is Creating Opportunities Across America's Workforce”
house Education and Workforce Committee · Jul 24, 2026 · Transcript
DR. JEFFERY TALBERT "The approval process for that goes through something very similar to medications. So to get a medication approved, you know, it has to go through the clinical trial process and to be approved. So the AI tools go through the same process, or a very similar process that those drugs go"
Hearing Hearings to examine the Consumer Financial Protection Bureau Semi-Annual Report, focusing on a new day at the CFPB through reform.
senate Banking, Housing, and Urban Affairs Committee · Jul 16, 2026 · Transcript
SMITH, TINA "So the clear feeling amongst folks in my home state is that what's happening is that there is a political screen that is being imposed on grants. And here's an example of one of these situations. One of my constituents in Minnesota was participating in an NIH-funded clinical trial to treat stomach cancer. The trial was canceled, unexpectedly halted. This person never received their surgery. And the trial never"
CRS Report
“Skinny Labels” for Generic Drugs Under Hatch-Waxman
InFocus · Jul 27, 2026
New “brand-name” drugs are often protected from generic competition by patents. In general, a drug manufacturer intending to market a generic version of a brand-name drug must either wait for those...
CRS Report
Vanda Pharmaceuticals, Inc. v. United States: Fifth Amendment Takings Claims for Alleged Disclosures of Trade Secrets and Confidential Information
Posts · Apr 8, 2024
On January 18, 2024, the U.S. Court of Federal Claims denied, in part, the government’s motion to dismiss a lawsuit brought by Vanda Pharmaceuticals, Inc. (Vanda) for alleged disclosure of...