Since returning to office for a second term, President Trump has taken steps to reshape federal agencies. Here, we discuss the significant changes that have occurred at the Food and Drug Administration (FDA or Agency) during the first 100 days of the second Trump administration, including (1) the appointment of a new commissioner; (2) changes in FDA leadership; and (3) plans to reorganize the Agency and reduce its workforce.
New FDA Commissioner
On March 25, 2025, Martin "Marty" Makary was confirmed by the Senate to be the 27th Commissioner of Food and Drugs (FDA commissioner). Former Acting Commissioner Sara Brenner will serve as principal deputy commissioner.
In remarks given during a welcome ceremony at FDA headquarters, Makary stated his goal is "to ensure that the FDA holds to the gold standard of trusted science, transparency, and common sense to rebuild public trust and advance health and safety in the United States and worldwide." Makary mentioned an array of different topics, including the "chronic disease epidemic," obesity, and autism, without announcing specific policy prescriptions. Makary discussed the need for people "with a range of perspectives and critical thinkers to respond following the scientific method and using common sense." Commissioner Makary will speak at the 2025 Food and Drug Law Institute (FDLI) Annual Conference on May 15, as well as Robert Foster, the U.S. Department of Health and Human Services (HHS) deputy general counsel and chief counsel for food, research, and drugs. The position of chief counsel for food, research, and drugs was created as part of the reorganization of HHS's office of the general counsel and supervises FDA's chief counsel.
As Makary's tenure progresses, we will be monitoring how he brings his vision for FDA into action.
FDA Leadership Changes
As Commissioner Makary began his tenure, FDA experienced layoffs, resignations, and retirements, all of which are ushering in a new regulatory environment for drugs, devices, and other regulated products. Below is the current state of FDA leadership as of April 28, 2025:
- Center for Devices and Radiological Health (CDRH)
- Michelle E. Tarver, Director
- Center for Drug Evaluation and Research (CDER)
- Jacqueline Corrigan-Curay, Acting Director
- Center for Biologics Evaluation and Research (CBER)
- Scott Steele, Acting Director (replaced Peter Marks, who resigned earlier this month)
- Center for Tobacco Products (CTP)
- Vacant, Director (previously held by Brian King, who was placed on administrative leave earlier this month)
- Human Foods Program
- Kyle Diamantas, Acting Deputy Commissioner for Human Foods (replaced James "Jim" Jones, who resigned in February 2025)
Additionally, it was reported that Makary made the following appointments last week as part of his efforts to finalize his team:
- Center for Veterinary Medicine (CVM)
- Timothy Schell, Acting Director
- Craig Taylor, Acting Chief Information Officer (replaced Vid Desai, who was placed on administrative leave earlier this month)
- Lowell Zeta, Deputy Commissioner for Strategic Initiatives
Additional leadership positions remain vacant as of April 28, 2025, including chief counsel and chief medical officer.
Implications of Staffing Cuts, Proposed Agency Restructuring, and Budget Changes
In April, HHS began implementing plans to reduce its workforce, which, according to a fact sheet, will result in FDA losing "approximately 3,500 full-time employees." The fact sheet states that the cuts "focus on streamlining operations and centralizing administrative functions" and "will not affect drug, medical device, or food reviewers, nor will [they] impact inspectors." These cuts follow an earlier round of terminations that occurred in February. Notably, there have been reports that FDA has rehired or reinstated some fired personnel, suggesting that cuts may have been made to positions that the Agency later determined were necessary.
Return-to-office orders could further reduce FDA's workforce along with the planned staffing cuts. Employees living outside a 50-mile radius of FDA's headquarters are to report in person starting April 28, potentially leading to attrition. Moreover, according to reports, HHS has considered a plan to restructure FDA into five or six offices, by merging similar activities of the centers, such as product reviews, policy, and inspections, into single offices. Additionally, news outlets have reported on a leaked HHS budget document that proposes significantly reducing FDA's overall funding but allocates adequate funding to maintain the user fee programs.
Although Makary has struck a positive tone so far, the combination of staffing cuts, a smaller budget, and a reorganization of the Agency could impact FDA's ability to review regulated products. Several PDUFA decision dates are pending in the next few weeks that may provide insight into FDA's current ability to meet target deadlines. Additionally, there are reports that FDA is planning to end most of its routine food inspections work, which would be outsourced to state and local authorities. Meanwhile, FDA recently announced its plan to phase out petroleum-based synthetic dyes from the U.S. food supply. Further, the Agency is continuing to work to educate stakeholders about the updated "healthy" nutrient content claim rule, which went into effect April 28, by publishing a pre-recorded webinar that outlines the rule.
Venable will continue to monitor all changes regarding FDA and report any critical developments. If you have questions on how the contents of this article may impact you or your business's interactions with FDA, please contact the authors today.