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.