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On October 29, 2025, the Senate HELP Committee held a hearing on the future of biotech. The members heard testimony on the current state of biotech in the United States as well as how to address coming challenges. There was strong bipartisan support of the need for domestic drug manufacturing and maintaining US competitiveness in the global arena.
Opening Statements
Witness Testimony
- Lowell Schiller, JD, Nonresident Senior Scholar, USC Schaeffer Institute – Testimony
- John F. Crowley, JD, MBA, President and CEO, Biotechnology Innovation Organization (BIO) – Testimony
- Josh Makower, MBA, Yock Family Professor of Medicine and Bioengineering, Byers Family Director and Co-founder Stanford Mussallem Center for Biodesign, Stanford University Schools of Medicine and Engineering – Testimony
- Aaron S. Kesselheim, JD, MPH, Professor of Medicine, Harvard Medical School/Bringham and Women’s Hospital – Testimony
- Reshma Ramachandran, MPP, MHS, Assistant Professor of Medicine, Yale School of Medicine – Testimony
Member Discussion
Domestic Manufacturing
The most widespread concern from members, including Sens. Banks (R-IN), Blunt Rochester (D-DE), Kaine (D-VA), and Chairman Cassidy (R-LA), was how to encourage domestic manufacturing of biotech. Sen. Blunt Rochester highlighted the lack of a national comprehensive plan to address US biotech innovation and manufacturing. When asked by Sen. Banks about ways for the Food and Drug Administration (FDA) to improve manufacturing, Mr. Schiller indicated a need to update regulations for modern technology and processes as well as have parity between domestic and global inspection standards. Chairman Cassidy raised the potential of using robotics to support domestic manufacturing of generic drugs, but Mr. Schiller responded that the upfront capital needed to open a robotics-based plant makes it unobtainable for companies.
Funding and Staffing Changes
Sen. Murray (D-WA), along with Sens. Hickenlooper (D-CO) and Blunt Rochester (D-DE), expressed concerns that funding changes to the National Institutes of Health (NIH) will greatly reduce US competitiveness and innovation in biotech due to decreased research. All 5 witnesses agreed that the funding changes pose serious risks to innovation and continued drug development. Dr. Ramachandran specifically highlighted the negative impacts on patients due to the cancellation of clinical trials and the brain drain that is occurring as scientists find employment opportunities in other countries. Mr. Crowley emphasized the important role that the NIH plays in basic and translation research, which builds the foundation for startup biotech companies and encourages investment capital from academic institutions and private organizations.
Similar concerns were raised about layoffs at the FDA and the Centers for Disease Control and Prevention (CDC). Sen. Kim (D-NJ) asked about current challenges with FDA resources, to which Dr. Makower responded that vacancies needed to be filled at a one-to-one rate to keep up with the workload of approvals, manufacturing plant inspections, and questions from biotech developers. Dr. Ramachandran highlighted the need for CDC action and surveillance to address growing public health concerns, like drug resistant super bugs, that have biotech solutions, novel antibiotics.
Cost
Sen. Sanders (I-VT) was the first to raise the point of the high cost of pharmaceuticals, often out pricing patients who cannot afford their medications. Dr. Ramachandran shared her experiences where patients request to skip a month of one of their medications or choose not to fill a prescription after seeing the cost at a pharmacy. Sen. Hassan (D-NH) suggested biosimilars could be a way to decrease costs if they can be brought to market quickly. Dr. Kesselheim agreed but elaborated that efforts need to be made to encourage prescribing of biosimilars as well as regulatory guidance to allow them to be interchangeable with their counterparts at pharmacies.
Sen. Hickenlooper questioned if there have been any negative outcomes on negotiating drug prices under the Inflation Reduction Act (IRA). Dr. Kesselheim stated there have been no changes to innovation and the results have only showed drug prices can be decreased. Sen. Cassidy followed up, trying to understand if there has been a difference in investments by biotech companies because of the IRA. Mr. Crowley stated the largest result he has seen is the focus shift from small to large molecules.
Possible Regulations
Sen. Moody (R-FL) asked what regulatory improvements could be made to improve the FDA. Mr. Crowley expressed the need for faster, clearer guidance from the FDA through the approval process. He also suggested the consideration of surrogate endpoints or risk/benefit assessments for rare disease therapies.
Sen. Kaine wanted input from the panel about the Vaccine Injury Compensation Program and whether reform was needed. Dr. Kesselheim expressed support for the VICP, especially how it supports US production of vaccines. Mr. Crowley was also supportive of the program, stating that the system works and should be preserved and strengthened.
Chairman Cassidy led the conversation about the 3rd party review process for the FDA, questioning why the FDA will re-review approvals. Dr. Makower expressed the variable quality for 3rd party reviews and the need to implement a quality control process if there is a desire to increase 3rd party usage. Dr. Ramachandran echoed the point and discussed the need for greater oversight.
We recently welcomed Katie Meadows as Research Associate. We sat down with Katie to talk about her background, what she thinks are the biggest challenges in health policy right now, and how her skills and experience will be an asset to our clients.
Tell us a little about your background and how that background prepares you for this new role.
I’m a proud double Hoya with an MS in Health and the Public Interest and BS in Human Science and Public Health, both from Georgetown University. While completing my degrees, I interned at the Substance Abuse and Mental Health Services Administration and volunteered with a student-run health and science advocacy organization. These experiences gave me the chance to explore federal policy from multiple angles and gain experience working to accomplish shared goals. In my new role, I hope to leverage these skills and experiences to support the needs of Chamber Hill Strategies’ clients.
What drew you to join a government affairs firm with a health care focus?
I wanted to find a workplace that would enable me to explore many areas of health care policy and gain applicable experience. I was drawn to Chamber Hill Strategies due to the firm’s bipartisan focus and broad reach in areas such as Medicare/Medicaid reimbursement, rural health, and the health care workforce. Working for a firm with such a diverse group of clients will allow me to build a strong professional foundation.
What are the core areas of health care policy you’re most passionate about or experienced in?
One area of health care policy that I am very passionate about is mental health and well-being, especially for children and adolescents. While there has been a growing focus on the area, there are more steps to be taken to ensure that children receive the care they need. I am interested in gaining experience in the current health insurance landscape so I can better assist clients in navigating this space.
What do you see as the biggest challenges (and opportunities) in health care policy right now?
Some of the biggest challenges that I currently see in health care policy are ensuring access to quality care and addressing the growing health care workforce crisis. Many communities, such as those in rural or underserved areas, continue to face barriers to care due to high costs, hospital closures, provider shortages, and limited access to services. At the same time, many providers are experiencing high patient loads, burnout, and system-wide staffing shortages. These issues, both separately and combined, impact the timeliness of care and create roadblocks to improved population health.
What will your role at the firm entail — what are you looking forward to doing here?
I currently produce the firm’s daily health care policy report, PolicyCrush, along with the weekly report on upcoming events. I also analyze policy both in legislation and regulation. I am looking forward to gaining experience and learning from my colleagues at Chamber Hill Strategies. The mentorship that I have already received has been invaluable. I am excited to continue to grow in my role and continue supporting the firm’s work on behalf of our clients.
How do you like to approach problem-solving in complex policy settings?
For complex issues, I think it is important to understand how different parties are approaching the problem and what their goals are. From there, I try to find commonalities between the different approaches to foster discussion on finding a shared way forward.
Outside of work, what motivates you or keeps you energized?
I love spending time with my friends and family, exploring all DC has to offer. Whether it is finding new coffee shops and restaurants to try or visiting the Smithsonian museums, I enjoy taking the time to connect with the people and world around me.
What else should your colleagues or clients know about you?
I am always looking for new book recommendations, both insightful and fun, as I find reading a good way to relax and escape for a bit while still learning. I also love to travel and explore new countries, especially trying local foods.
Do you have any book or travel recommendations for us?
One book I recently read was Everything is Tuberculosis by John Green, an author I grew up reading. I enjoyed seeing a new side of his writing and the way he highlighted a longstanding global health challenge. In terms of travel, one of my favorite cities I recently visited is Florence, Italy. I would love the chance to visit again.
On October 23, 2025, the Senate HELP Committee held a hearing to examine the 340B Program’s growth and impact on patients. The members heard testimony on how the program functions as well as some current challenges that have been identified. There was strong bipartisan support for the continuation of the program, but there were also calls from both sides of the aisle for careful regulations to ensure the program’s continuing success.
Opening Statements
Witness Testimony
- Michelle Rosenberg, Director, Health Care, U.S. Government Accountability Office (GAO)– Testimony
- Dr. Aditi Sen, Chief, Health Policy Studies Unit, Congressional Budget Office (CBO) – Testimony
- William B. Feldman, Physician and Health Policy Researcher, University of California, Los Angeles – Testimony
Member Discussion
The most common line of questioning from members, including Sen. Tuberville (R-AL), Sen. Murkowski (R-AK), Sen. Kim (D-NJ), Sen. Collins (R-ME), and Sen. Banks (R-IN), was regarding how 340B Program facilities use the savings from the program in their operating budgets. Ms. Rosenberg responded each time that there are no specific requirements in the program on how to use the funds, and Dr. Sen elaborated that the CBO does not have the data required to have a full understanding of how different entities are using the funds. Sen. Hassan (D-NH) suggested that reporting requirements for revenue generated by the program could increase transparency and guide future regulations on its use.
Sen. Baldwin (D-WI), who is a member of a bipartisan 340B working group, raised concerns about the new 340B Rebate Model Pilot Program, which requires program participants to purchase pharmaceuticals at market price and receive a rebate later, creating greater upfront costs. Dr. Feldman shared these concerns and suggested a 3rd party clearing house could be a solution to ensure that pharmaceutical companies and health care providers are able to reach equitable agreements.
Sen. Marshall (R-KS) suggested that creating a definition of a patient under the program, considering factors such as recency or frequency of visits, could aid in regulating eligibility requirements. Dr. Sen agreed but cautioned that any narrowing of the definition would have implications that would need to be understood.
When asked by Sen. Kaine (D-VA) and Sen. Baldwin about recommendations for 340B program reforms, Ms. Rosenberg suggested the 15 recommendations GAO previously made to HRSA, through reports on June, 28 2018, January 10, 2020, and January 27, 2020, that have not been implemented. These include addressing duplicate discount policies, more auditing of contracts and hospital systems, and more data collection on cost savings and use. Sen Hickenlooper (D-CO) continued this line of questioning with the need for more HRSA oversight, which requires authorization to impose regulations and staffing levels to uphold them.
Sen. Kim, Sen. Murray (D-CT), Sen. Markey (D-MA), and Sen. Alsobrooks (D-MD) all discussed how stretched 340B hospital systems’ budgets are, and they raised concerns about how policy decisions such as not renewing advance premium tax credits (APTCs) could make things worse. Dr. Feldman agreed and stressed that any increase in the uninsured population would lead to providing more uncompensated care and a larger burden on the providers in those systems. Sen. Collins and Sen. Murkowski were concerned that regulations limiting 340B hospitals would have a disproportionate impact on rural hospitals that rely more heavily on the 340B program to provide care to their patients.
On October 22, 2025, the Senate Special Committee on Aging held a hearing on how shoppable health services can improve outcomes and lower costs. Committee members heard testimony on different ways to reduce costs, especially for older Americans.
Witness TestimonyÂ
- Mark Cuban, Co-Founder, Cost Plus Drugs – Testimony
- G. Keith Smith, Co-Founder, Surgery Center of Oklahoma and the Free Market Medical Association – Testimony
- Don Moulds, Chief Health Director, CalPERS – TestimonyJeanne Lambrew, Director of Health Care Reform and Senior Fellow, The Century Foundation – Testimony
Member Discussion
Prescription Drugs and Pharmacy Benefit Managers (PBMs)
One major topic of discussion was ways to address the high cost of prescription drugs. Sen. Tuberville (R-AL) asked how direct-to-patient programs, like Cost Plus Drugs save patients money. Mr. Cuban responded by saying that these companies build trust with patients through transparent pricing and can charge less as there are no intermediaries.
There was bipartisan interest in addressing concerns about PBMs. Sen Husted (R-OH) mentioned his concerns about a lack of competition if insurance companies are able to create monopolies by owning PBMs and pharmacies. He also noted his concerns that this would further increase price and push smaller independent providers out of business. Sen. Warren (D-MA) expanded on this line of questioning through the discussion of the Department of Defense TRICARE provider, Cigna, who also owns PBM Express Scripts, as well as specialty pharmacy Accredo. She noted her concern that this enables Express Scripts to highly encourage patients to use Accredo and reimburse other pharmacies at lower rates causing independent practices to go out of business.
Sen. Justice (R-WV) mentioned mimicking state legislation that passes the PBM cost savings onto patients as a way to respond to large profits by PBMs.
Pricing Transparency
Multiple senators, including Sen. Tuberville, Sen. Marshall (R-KS), and Sen. Moody (R-FL), questioned whether publishing prices encouraged patients to shop for care. Dr. Smith testified that his clinic often serves out-of-state and out-of-country patients due to their low prices. Patients were also able to use his clinic’s publicly posted prices to negotiate with their local hospital systems and price match.
Chairman Scott (R-FL) and Ranking Member Gillibrand (D-NY) were curious about the logistics of reference-based pricing in the CalPERS system and how competition between hospital systems can be beneficial. Dr. Moulds emphasized that due to CalPERS’ size, they had more power than smaller systems but still faced price differentials between geographic areas that had greater amounts of providers and smaller amounts of providers. Dr. Moulds was also frank that not all health services can be referenced-based, and that CalPERS makes decisions on how to balance encouraging members to receive care with the potential cost of care.
Advance Premium Tax Credits (APTC)
Sen. Gillibrand was the first of many members, including Sen. Warnock (D-GA) and Sen. Kelly (D-AZ), to highlight the increased premium costs due to the expiration of APTCs. Concerns were raised about the affordability of health insurance and how the 55-65 aged community will respond to the increased price. Dr. Lambrew emphasized that adults aged 55-65 will be the most affected by the rise in premium costs due to their reliance on the health care marketplace and their greater need to receive care. Dr. Lambrew and Mr. Cuban agreed that many will forgo health insurance to pay for other expenses.
Sen. Johnson (R-WI) pressed Dr. Lambrew on the design of the Affordable Care Act and the continued growth in health care costs. Dr. Lambrew maintained the position that although the tax credits were not part of the original design of the ACA, they were an improvement that should be continued.