Why It Matters
The House Energy and Commerce Subcommittee on Health held a hearing July 15 examining FDA biomedical innovation, with lawmakers and witnesses raising concerns about whether the agency can maintain U.S. leadership in drug development following significant staffing reductions. The hearing highlighted questions about balancing government efficiency, regulatory certainty and biomedical competitiveness.
The subcommittee examined how the FDA can maintain American leadership in biomedical innovation while continuing to serve patients, promote innovation and preserve the nation's competitive standing. Much of the discussion focused on the agency's staffing challenges, regulatory consistency and its ability to retain scientific expertise.
The Big Picture: Staffing Crisis Threatens Regulatory Stability
The FDA biomedical innovation hearing came as the agency grapples with the fallout from sweeping personnel cuts. The FDA eliminated 3,500 jobs, the most of any HHS agency. The agency lost senior leaders and rank-and-file scientists, contributing to concerns about morale and institutional knowledge.
The cuts followed FDA Commissioner Marty Makary's resignation on May 12 after leading the agency for about 13 months. His departure marked the fourth high-profile HHS leadership departure during the administration. The directors of the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research were subsequently removed. DOGE-driven layoffs prompted the FDA to recruit volunteers to complete drug reviews. The layoffs also affected employees responsible for approving drug labels, posting recall notices and testing food and drug samples.
As of the hearing, the FDA was actively hiring 2,200 employees to rebuild its workforce. Witnesses and lawmakers questioned whether the agency could restore institutional knowledge and regulatory credibility after months of organizational upheaval.
The hearing also previewed a critical legislative deadline. PDUFA VII expires Sept. 30, 2027. FDA and industry consultation meetings on the next user-fee agreement continued through the spring, with a final negotiated agreement due to Congress by Jan. 15, 2027. User-fee reauthorizations generally occur every five years, making the upcoming cycle an important opportunity for regulatory reform.
What They're Saying: Witnesses Describe Policy Chaos and Competitive Threats
The FDA biomedical innovation hearing featured five witnesses: Susan Winckler from the Reagan-Udall Foundation for the FDA, Aaron J. Kowalski from Breakthrough T1D, Dr. Thomas Hwang from Brigham and Women's Hospital and Harvard Medical School, Dr. Cynthia Verst from IQVIA, and Thomas J. Bollyky from the Council on Foreign Relations.
Witnesses described an agency facing significant operational challenges. Several testified that changing policies and staffing disruptions had reduced regulatory predictability, which they said is central to the FDA's global reputation.
FDA Commissioner Makary launched a national priority voucher program that provides incentives to companies without predefined eligibility criteria. Makary also initially declined to review an mRNA-based influenza vaccine before later reversing course. The FDA also initiated a proposed acetaminophen pregnancy warning that drew criticism from several medical organizations, which argued the available evidence did not support the change.
Several witnesses also criticized the FDA's policymaking process. They said the agency announced major policy changes through journal articles, press releases and podcasts rather than through its traditional guidance process, creating uncertainty about official FDA policy. Witnesses also discussed the FDA's decision to require an additional clinical trial for an experimental Huntington's disease gene therapy, a move that some researchers and patient advocates argued was unethical.
Rep. Diana DeGette (D-Colo.), ranking member of the Subcommittee on Health, raised similar concerns in February, sending a letter to the FDA regarding the agency's adherence to its good guidance practices. The FDA responded that the announcements in question did not constitute formal guidance and did not establish official FDA policy.
Witnesses emphasized that the United States remains the global leader in developing safe and effective medical products, allowing Americans to gain early access to innovative therapies. Several cautioned, however, that other countries, particularly China, are investing heavily in biotechnology, clinical trials and domestic manufacturing.
Thomas Bollyky, who holds the inaugural Bloomberg Chair in Global Health at the Council on Foreign Relations, discussed biotechnology's growing importance in U.S.-China strategic competition. Witnesses warned that the United States risks losing its competitive edge in biomedical research and development if regulatory uncertainty persists.
The Biotech Investment National Security Act (BINSA) was introduced with bipartisan support. The legislation would add biotechnology and pharmaceutical development to covered national security review sectors and expand scrutiny of U.S.-China licensing agreements and joint ventures. The hearing suggested Congress is approaching the next FDA user-fee reauthorization with increased attention to national security concerns.
Political Stakes: A Vulnerable Administration, Urgent Reform Needs
For the Trump administration, the hearing highlighted questions about whether aggressive cost-cutting can be balanced with maintaining the FDA's regulatory capacity. Witnesses repeatedly pointed to staffing reductions, changing policies and leadership turnover as challenges facing the agency.
For Congress, the hearing framed the upcoming user-fee reauthorization as an opportunity to establish additional guardrails for FDA leadership and improve transparency in the agency's policymaking process. Rep. Morgan Griffith (R-Va.), who chairs the Subcommittee on Health, is expected to play a leading role in that effort. DeGette has also indicated she intends to continue pressing the agency on governance and transparency.
For the broader biomedical sector, the stakes remain high. The United States has long led the world in biopharmaceutical research and development. User-fee programs have provided the FDA with resources to review innovative drugs and medical devices for more than three decades. Performance goals established through those agreements have shortened review times, improved communication between regulators and product developers and increased consistency throughout the review process.
FDA decisions remained relatively steady during the first half of the year despite staffing disruptions. The agency issued eight novel drug application rejections, while approvals for biologic therapies declined. Witnesses said those metrics suggest the FDA continues to function but warned that prolonged staffing challenges could eventually affect performance.
Acting FDA Commissioner Kyle Diamantas has said he intends to empower career experts to carry out the agency's scientific work. Witnesses said restoring the FDA's credibility will require more than rebuilding staffing levels and argued Congress should establish clearer expectations for agency governance.
The Other Side: Rebuilding Momentum and Regulatory Reform
Not all testimony was pessimistic. According to BIO News, one reason for optimism discussed at the BIO convention was the FDA's effort to rebuild its workforce and restore institutional knowledge. The Global Health Technologies Coalition argued that staffing reductions could weaken U.S. competitiveness but suggested rebuilding the agency could strengthen long-term growth.
Industry observers also highlighted opportunities for regulatory reform. The Foundation for Defense of Democracies said HHS' proposed clinical trial reforms could strengthen U.S. biomedical competitiveness if paired with greater regulatory certainty. Fierce Pharma reported that the Institute for Clinical and Economic Review called on the FDA to strengthen evidence standards for accelerated drug approvals and improve transparency surrounding those decisions.
The National Security Commission on Emerging Biotechnology outlined 83 policy options to streamline regulation and accelerate biotechnology development. The proposals reflect broader efforts to modernize the regulatory system while maintaining safety standards.
What's Next: User Fee Reauthorization and Legislative Action
No legislation has been directly tied to the July 15 hearing. Historically, however, hearings on FDA policy have often preceded broader user-fee reauthorization legislation.
Congress is also considering proposals to modernize clinical trial networks by embedding them in routine care and expanding access to innovative treatments in rural communities. Those initiatives suggest the upcoming reauthorization debate will extend beyond FDA operations to the broader biomedical research ecosystem.
Although the hearing served as an oversight discussion rather than an investigative hearing, lawmakers indicated FDA governance and transparency will remain priorities as Congress considers the next user-fee agreement.
The Bottom Line
The FDA biomedical innovation hearing exposed a fundamental contradiction in the Trump administration's approach to federal agencies: cost-cutting that undermines the very functions those agencies are meant to perform. Restoring FDA's role as the world's gold standard regulator will require not just hiring and institutional recovery, but clearer rules on how the agency makes policy and communicates with industry and the public.
Access the Legis1 platform for comprehensive political news, data, and insights.
Spot something wrong? Report an issue with this article