FDA Staffing Crisis and Policy Chaos Threaten U.S. Biomedical Innovation Leadership, Congressional Hearing Reveals
核心洞察
The House Energy and Commerce Health Subcommittee convened on July 15 to examine how FDA staffing cuts and policy disruptions are undermining U.S. biomedical innovation leadership.
The layoff of 3,500 FDA employees has reduced regulatory predictability, with drug applicants receiving less guidance, fewer updates, and less predictable approval timelines.
Witnesses warned that China is investing heavily in biotechnology and clinical trials, threatening U.S. competitiveness if regulatory uncertainty persists.
The House Energy and Commerce Health Subcommittee convened on Wednesday, July 15, to confront a growing crisis at the Food and Drug Administration, where sweeping staffing reductions and erratic policymaking have raised urgent questions about the agency's ability to maintain its role as the world's gold-standard drug regulator.
The hearing followed the resignation of FDA Commissioner Marty Makary on May 12, after leading the agency for approximately 13 months. His departure marked the fourth high-profile leadership exit within the Department of Health and Human Services during the current administration. The directors of both the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research were subsequently removed, deepening the leadership vacuum.
The layoff of 3,500 FDA employees has had what experts describe as a major impact on drug and device applicants, who are now receiving less guidance, fewer updates on applications, and face increasingly unpredictable approval dates. DOGE-driven layoffs prompted the agency to recruit volunteers to complete drug reviews, while employees responsible for approving drug labels, posting recall notices, and testing food and drug samples were also affected. As of the hearing, the FDA was actively hiring 2,200 employees in an effort to rebuild its workforce.
Witnesses Describe Policy Chaos and Competitive Threats
The hearing featured testimony from five witnesses: Susan Winckler of the Reagan-Udall Foundation for the FDA (搜索), Aaron J. Kowalski from Breakthrough T1D (搜索), 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 (搜索).
Several witnesses testified that changing policies and staffing disruptions had reduced regulatory predictability, which they described as central to the FDA's global reputation. The witnesses criticized the agency's policymaking process, noting that major policy changes were being announced through journal articles, press releases, and podcasts rather than through the FDA's traditional guidance process, creating uncertainty about what constitutes official FDA policy.
Among the controversial decisions cited: Commissioner Makary launched a national priority voucher program providing incentives to companies without predefined eligibility criteria; the FDA initially declined to review an mRNA-based influenza vaccine (搜索) before reversing course; and the agency proposed an acetaminophen pregnancy warning that drew criticism from multiple medical organizations, which argued the available evidence did not support the change.
Witnesses also discussed the FDA's decision to require an additional clinical trial for an experimental Huntington's disease (搜索) 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, had 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.
National Security and Competitive Pressures
Thomas Bollyky, who holds the inaugural Bloomberg Chair in Global Health at the Council on Foreign Relations (搜索), 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, noting that China is investing heavily in biotechnology, clinical trials, and domestic manufacturing.
The Biotech Investment National Security Act (BINSA) has been 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.
Agency Performance Amid Disruption
Despite the staffing disruptions, FDA decisions remained relatively steady during the first half of the year. 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. However, witnesses argued that restoring the FDA's credibility will require more than rebuilding staffing levels, and urged Congress to establish clearer expectations for agency governance.
Rebuilding Momentum and Reform Opportunities
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 while staffing reductions could weaken U.S. competitiveness, rebuilding the agency could strengthen long-term growth.
Industry observers 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. The National Security Commission on Emerging Biotechnology outlined 83 policy options to streamline regulation and accelerate biotechnology development.
The Road Ahead: PDUFA VII and Legislative Action
PDUFA VII expires on September 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 January 15, 2027. User-fee reauthorizations generally occur every five years, making the upcoming cycle an important opportunity for regulatory reform.
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. Although the July 15 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 hearing exposed a fundamental tension in the administration's approach to federal agencies: cost-cutting measures that undermine the very functions those agencies are meant to perform. Restoring the 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.