By Patrick Cooney, for AMRC
Illustrative image generated using AI
FEDERAL AGENCY NEWS
New FDA Commissioner Nominated
On August 19, 2026, President Trump announced that he is nominating Dr. Heidi Overton, currently deputy director of the White House Domestic Policy Council, to be the next FDA Commissioner, filling the vacancy left by Marty Makary’s resignation in May. Trump explicitly tied the pick to “MAJOR Clinical Trial Reforms,” alongside faster cures, drug pricing, and MAHA priorities — signaling that clinical trial modernization will remain a top-tier agenda item at FDA under new leadership. Overton holds an MD from the University of New Mexico and a PhD in clinical investigation from Johns Hopkins Bloomberg School of Public Health, and has been a central architect of the administration’s health agenda, including the recent childhood vaccine executive order.
Why it matters for AMRC members: The nomination arrives as FDA is mid-stream on several clinical trial modernization efforts relevant to research funders — including a proposed Expedited IND pilot, real-time clinical trial pilots, and continued C3TI (Center for Clinical Trial Innovation) activity. Senate HELP Chair Bill Cassidy (R-LA), a physician, has already voiced “strong concerns” about Overton’s lack of managerial experience and her role in the vaccine executive order, setting up a contentious confirmation fight this fall.
CAPITOL HILL NEWS
PDUFA Reforms Framework Released
The FDA recently released its framework for the eighth iteration of the Prescription Drug User Fee Act (PDUFA VIII) that could have important implications for AMRC members and the broader clinical research enterprise. The proposed agreement would largely preserve FDA’s existing drug application review timelines while expanding regulatory science programs, creating new mechanisms for earlier FDA-sponsor engagement, and using the user fee structure to encourage more early-stage clinical research in the United States.
For AMRC, one of the most consequential provisions is a proposed 50% reduction in the PDUFA application fee for sponsors whose applications include data from at least one qualifying Phase 1 clinical trial “anchored in the United States” and initiated after October 1, 2027. The proposal reflects growing concern among policymakers and industry leaders that clinical research activity is migrating overseas because of lower costs, faster enrollment, and more efficient trial infrastructure in other countries. Although FDA has not yet fully defined what constitutes a trial “anchored” in the United States, the provision could create a meaningful financial incentive for sponsors to conduct early-stage research through U.S. clinical research organizations and sites.
This provision aligns closely with AMRC’s broader advocacy around strengthening U.S. clinical trial competitiveness. Congress and the Administration are increasingly focused not simply on supporting biomedical innovation, but on ensuring that the United States remains an attractive location in which to conduct clinical trials. For AMRC and its members, PDUFA VIII therefore creates an opportunity to advocate for policies that address the operational factors influencing where sponsors place trials—including startup timelines, contracting, patient recruitment, regulatory burden, decentralized and multisite trial infrastructure, and the ability to generate high-quality evidence efficiently.
The proposal also dovetails with the clinical trial reform efforts being developed by Rep. Jake Auchincloss (D-MA), who has argued that rising costs and slower trial timelines threaten U.S. biomedical competitiveness.
Another particularly important provision for AMRC members would establish a process allowing sponsors to identify a submitted protocol as a “Pivotal Protocol” when the study is expected to provide the primary evidence supporting an efficacy claim. FDA would prioritize review of these protocols, potentially allowing sponsors to resolve critical regulatory questions before initiating costly late-stage studies.
For multisite research organizations, earlier FDA agreement on pivotal trial design could reduce protocol amendments, site retraining, contracting changes, enrollment disruptions, and other downstream costs associated with changing a study after sites have been activated.
The proposed agreement also addresses concerns about FDA’s depleted scientific workforce. CDER and CBER have continued to experience staffing losses following the broader HHS workforce reductions that began in 2025, raising questions about whether FDA will have sufficient personnel to fulfill increasingly complex PDUFA commitments.
PDUFA VIII would establish a new Personnel Compensation and Benefits (PC&B) set-aside intended to rebuild FDA’s drug review workforce to approximately FY 2025 levels. It would also link FDA’s ability to collect additional workload-based revenue through the Capacity Planning Adjustment to achievement of annual personnel-spending targets.
This issue is important for AMRC because regulatory modernization cannot succeed without adequate FDA scientific and technical capacity. Expanded use of complex trial designs, real-world evidence, AI-enabled research methods, novel endpoints, and innovative statistical approaches will require reviewers with specialized expertise.
The bottom line for AMRC members is that PDUFA VIII is developing into more than an FDA user-fee agreement. It could become a legislative vehicle for a broader debate over how the United States competes for clinical research. The proposed 50% application-fee reduction for U.S.-anchored Phase 1 trials gives AMRC a particularly strong opening to argue that Congress should address the full clinical trial ecosystem and recognize multisite research infrastructure as a strategic component of U.S. biomedical competitiveness.
