Through our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or Agency) that may affect the Agency's structure and stakeholder interactions. This week's updates are as follows:
- Commissioner Makary gives fireside chat at the 2025 Food and Drug Law Institute (FDLI) Annual Conference
- The U.S. Department of Health and Human Services (HHS) Deregulatory Initiative
- A federal lawsuit brought by 20 attorneys general against HHS
Dr. Martin Makary's Fireside Chat at FDLI Annual Conference
Dr. Martin Makary, renowned public health expert, advisor, and newly appointed FDA commissioner, delivered a highly anticipated Fireside Chat today at the FDLI Annual Conference in Washington, DC. His remarks addressed the FDA's priorities following the recent reduction in force, including a commitment to the gold standard science, and restoring agency morale. Makary reiterated there are no plans for major reorganization, affirming the FDA's product-by-product review structure. He emphasized the need for strong but independent partnerships with industry, highlighted the unique challenges of rare disease approvals, and underscored efforts to reduce burdens and streamline the approval process.
HHS Opens 60-Day Public Comment Period on Deregulatory Initiative
HHS and FDA have initiated a 60-day public comment period to gather feedback on their proposed deregulation plan. This initiative, aligned with the "10-1" directive, is intended to eliminate at least 10 existing regulations for every new one introduced. Stakeholders are encouraged to submit their suggestions for regulations, guidance documents, or policies that may be outdated, burdensome, or unnecessary. Comments can be submitted through the official portal at regulations/gov/deregulation until July 14, 2025.
HHS Restructuring and Layoffs Face Legal Challenge
On May 5, 2025, attorneys general, representing 19 states and the District of Columbia, filed a lawsuit in Rhode Island federal court, alleging that HHS's restructuring effort and staffing cuts have hindered HHS and its agencies' ability to perform their statutory functions. Regarding FDA, the complaint argues that the layoffs will prevent the Agency from "promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner." The complaint discusses the effects of certain terminations, including how FDA suspended a planned bird flu detection exercise because employees working in an Illinois food safety lab were fired. The attorneys general claim their states "are already suffering consequences of these terminations and reorganizations" and seek declaratory and injunctive relief to stop HHS's restructuring and workforce reduction.