The beginning of the second Trump administration has been marked by significant—and often sudden—efforts to shrink the federal workforce and replace agency leadership to establish and deliver on a new set of priorities. In the past weeks, the administration has pursued a deferred resignation program,[1] terminated employees both in leadership and on probationary status,[2] and announced plans for a forthcoming government-wide reduction in force.[3] The U.S. Food and Drug Administration (FDA) has not been immune to these changes. Although the landscape at FDA continues to evolve, we expect the following trends to have a significant impact to regulated life science companies:
- A Slower Review Process? Staffing cuts in the agency divisions responsible for review of premarket submissions should be expected to result in longer review times for pending or future submissions. Although FDA has been working to reverse some of the terminations, cuts have notably impacted the Center for Devices and Radiological Health (CDRH), the Center for Tobacco Products (CTP), and the Office of Generic Drugs (OGD) within the Center for Drug Evaluation and Research (CDER).[4] Democratic senators and representatives have written to Robert F. Kennedy, Jr., the newly confirmed Secretary of the Department of Health and Human Services (HHS), highlighting the significant impact these cuts would have on important therapeutic products, particularly those that treat underserved patient populations and rare diseases as well as vaccines and other countermeasures to infectious diseases.[5] These cuts may only be the beginning, with additional cuts at agencies expected.[6] Reductions in agency staff will impact these and other product areas even though they are largely funded not by congressional appropriations, but rather by industry-paid user fees. The staffing cuts will likely push out agency decisions both favorable (e.g., marketing orders, approvals) and unfavorable (e.g., complete response letters), potentially past the review clocks to which the agency has committed under various user fee acts.[7]
- Impact on Inspections. Staffing cuts have also affected, and could also in the future affect, agency staff responsible for inspections, which could significantly impact both pre-commercial and commercial-stage life sciences companies.[8] Certain premarket submissions typically require pre-approval inspections of manufacturing or clinical trial sites, such as new drug applications (NDAs), biologics license applications (BLAs), and premarket applications (PMAs) for medical devices. Staffing shortages could impact the timeline for inspectors to arrive on site, respond to company submissions, and close out inspections to allow FDA to approve a product for marketing. In addition, any FDA-regulated companies that require a closeout inspection following an unfavorable inspection result or warning letter may also expect delays. These could include both application sponsors themselves as well as contract manufacturing and research organizations (CMOs and CROs) and clinical trial sites.
- Priorities TBD. Against this backdrop of likely increasingly scarce agency resources, changes in FDA leadership may have a particular impact on what work gets done: which applications are prioritized, which rulemaking or guidance is developed, which program areas will receive inspection resources, and what types of cases FDA will prioritize for enforcement action. Although Secretary Kennedy has been confirmed to the helm of FDA’s parent organization, HHS, the Senate has yet to confirm a new FDA Commissioner. President Trump has nominated Dr. Martin A. Makary, Chief of Islet Transplant Surgery at Johns Hopkins University, to the post, and confirmation hearings are set for March 6th.[9] Secretary Kennedy’s and Dr. Makary’s public positions have touched on, among other things, FDA approvals of opioids; using congressional appropriations, rather than user fees, for reviews of drugs, medical devices, and biological products; regulation of direct-to-consumer (DTC) advertising; and the use of vaccines and boosters to address communicable diseases.[10] The extent to which these priorities will be implemented, and if so, how, remains to be seen, particularly if congressional action or litigation limit or change FDA’s authorities. Their impact could span the entire lifecycle from product development to post-commercialization enforcement risk.
There is much uncertainty as to how FDA—and the companies it regulates—will ultimately be impacted as staffing continues to change. Life sciences companies should pay close attention to these trends and understand the potential impacts on their regulatory interactions and their business.
[1]See U.S. Office of Personnel Management (OPM), “Fork in the Road” (last accessed Feb. 27, 2025).
[2]See, e.g., “Health agencies lose staff members in key areas as Trump firings set in,”NPR (Feb. 17, 2025).
[3]Memorandum from R. Vought, Dir., U.S. Office of Management and Budget (OMB) and C. Ezell, Acting Director, OPM to Heads of Exec. Dep’ts and Agencies re: Guidance on Agency RIF and Reorganization Plans Requested by Implementing The President’s “Department of Government Efficiency” Workforce Optimization Initiative (Feb. 26, 2025).
[4]See, e.g., “In letter to RFK Jr., Democrats flag threats to drug review process from FDA firings,”FiercePharma (Feb. 24, 2025).
[5]See, e.g., Letter from Sen. J. Shaheen, Ranking Member, Subcomm. on Agriculture, Rural Development, FDA and Related Agencies, Sen. Comm. On Appropriations, et al. to Sec. R. Kennedy, HHS (Feb. 21, 2025); Letter from Sen. R. Wyden et al. to Sec. R. Kennedy, HHS (Feb. 19, 2025).
[6]OPM-OMB Memo Guidance on Agency RIF and Reorganization Plans Requested by Implementing the President’s DOGE Workforce Optimization Initiative (February 26, 2025).
[7]See, e.g., FDA, PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 through 2027; FDA, MDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 through 2027; FDA, GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023 through 2027; FDA, Biosimilar Biological Product Reauthorization Performance Goals and Procedures Fiscal Years 2023 through 2027.
[8]See, e.g., “Agency firings prompt worries about preparedness, FDA inspectors,”Roll Call (Feb. 19, 2025).
[9]See White House, “President Trump Announces Sub-Cabinet Appointments” (Jan. 20, 2025); Johns Hopkins Medicine, “Martin A. Makary, MD MPH” (last accessed Feb. 27, 2025). In the meantime, Dr. Sara Brenner, formerly Chief Medical Officer for In Vitro Diagnostics (IVDs) and Associate Director for Medical Affairs in CDRH is acting in that role. FDA, “Sara Brenner M.D., M.P.H.” (last accessed Feb. 27, 2025).
[10]See, e.g., “Healthy Returns: HHS Secretary RFK Jr. is making early moves that may affect vaccine access,”CNBC (Feb. 25, 2025); “RFK Jr. Says He Wants To Untie Links Between Industry and FDA,”Forbes (Dec. 4, 2024); “Makary for FDA. Here’s what you need to know,”Politico (Nov. 26, 2024); “A possible ban on DTC pharma ads poses ‘biggest threat’ of RFK Jr.’s HHS appointment: analyst,”FiercePharma (Nov. 25, 2024).