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. As Dr. Marty Makary marked 100 days on the job at the FDA by highlighting an embrace of "gold-standard science," this week's updates are as follows:
- The Latest Updates on Health and Human Services (HHS) Restructuring
- The Extension of the Federal Hiring Freeze and Concerns About the Impact of FDA Staffing Cuts
Latest Updates on Reduction in Force Litigation
In earlier updates, we noted several legal challenges to HHS's plans to restructure the agency as directed by the executive order Implementing the President's "Department of Government Efficiency" Workforce Optimization Initiative and a memorandum issued by the Office of Management and Budget (OMB) and the Office of Personnel Management (OPM). In a case led by the American Federation of Government Employees (AFGE) labor union seeking to stop the reductions in force (RIFs) and reorganization plans of HHS and other agencies, the Northern District of California previously granted a preliminary injunction after determining that the executive order and OMB/OPM memorandum—under which the RIF and reorganization plans were developed—are unlawful.
On July 8, the Supreme Court stayed the lower court's injunction, reasoning that the Trump Administration "is likely to succeed on its argument that the Executive Order and Memorandum are lawful—and because the other factors bearing on whether to grant a stay are satisfied—we grant the application." Although the court "express[ed] no view on the legality of any Agency RIF and Reorganization Plan produced or approved pursuant to the Executive Order and Memorandum," this decision means that agencies may move forward with restructuring plans while the AFGE litigation continues. Notably, other cases brought on similar grounds continue, including a case brought by 19 state attorneys general (in which the Rhode Island District Court ruled on July 1 to grant a preliminary injunction to pause the restructuring efforts).
HHS has not yet announced whether it will resume restructuring or RIF plans, or how it will proceed in light of the court decisions.
Federal Hiring Freeze Extended Amid Concerns Over the Impact of FDA Staffing Cuts
This week, President Trump issued a memorandum extending the federal government's hiring freeze, which was set to end on July 15, through October 15, 2025. Certain hiring is exempted from the freeze, such as "positions related to immigration enforcement, national security, or public safety." The freeze's extension comes as ProPublica reports on the potential impact of staffing cuts—particularly the termination of support staff responsible for booking travel and handling logistics for inspectors—on the FDA's ability to effectively inspect foreign drug manufacturing facilities for safety, and other reports raising concerns about staffing reductions and recent changes at the agency.
Venable will continue to monitor all changes regarding the FDA and report any critical developments. If you have questions about how the contents of this article may impact you or your business's interactions with the FDA, please contact the authors today.