There has been a flurry of activity at the Food and Drug Administration (FDA) since the start of the Trump administration. Day-to-day operations at FDA are already significantly altered, and we expect the trickle-down effects on industry to be felt soon.
Here, we provide a summary of the significant changes at FDA that have occurred during February and March 2025.
Staff
Reduction in force. On March 27, 2025, Secretary Robert F. Kennedy Jr. announced a sweeping reorganization of the Department of Health and Human Services (HHS). FDA’s workforce will be cut by 19%, with reductions primarily focused on “administrative” functions. (Exceptions were made for inspectors and drug, device and food review staff.) The FDA reductions were announced on April 1, 2025, and most staff was placed immediately on administrative leave. The impacted staff at FDA, including project managers, are essential for keeping user fee programs on track. Trade press has reported that sponsors already are beginning to see less responsiveness on application reviews and missed deadlines. We also expect to see less engagement with sponsors during the development process, as review division staff will have to focus their efforts on application reviews. Separately, the vast majority of policy staff were eliminated in an effort to centralize policy at HHS.
We anticipate that FDA will issue fewer guidances and regulations after this reorganization. Since regulated industry relies heavily on guidance documents written by FDA policy staff, a significant reduction in this area may have long-term effects on product development in the drug and device sectors and could limit or delay the rollout of any planned overhaul of the GRAS (Generally Recognized as Safe) pathway (discussed below).
Health secretary. As we have previously discussed, on February 13, 2025, Kennedy was confirmed as HHS secretary. He has an agenda that is deeply focused on issues under FDA’s jurisdiction, including food additives, nutrition, vaccines and prescription drugs.
FDA commissioner. On March 25, 2025, Dr. Marty Makary was confirmed as FDA commissioner. Dr. Makary is a practicing physician and thought leader who emphasizes the need for scientific rigor — for example, placebo-controlled trials — to support scientific decision-making and policy. Though he took the helm at FDA after many decisions about the agency’s staff and direction had already been made (both by Secretary Kennedy and the then-acting commissioner), Dr. Makary has continued on the set trajectory since being sworn in.
FDA chief counsel. A new FDA chief counsel has not yet been appointed to replace the two other lawyers who were previously placed in that role. Robert Foster was originally appointed, but he has since been promoted to deputy general counsel and chief counsel for Food, Research and Drugs, a newly created position in the HHS Office of the General Counsel; the FDA chief counsel will now report to him. Hillary Perkins also held the role of FDA chief counsel for two days before resigning due to her work on the abortion pill mifepristone while at the Department of Justice (DOJ) during the Biden administration.
Center for Drug Evaluation and Research (CDER). Since the beginning of the Trump administration, many career leaders in CDER have retired or resigned, including the center director and two deputy center directors. CDER is currently being led by an acting center director, but none of the other open roles have been filled permanently. We anticipate further changes to CDER leadership and structure.
Center for Devices and Radiological Health (CDRH). The director of CDRH, Dr. Michelle Tarver, was appointed to the position in October 2024, prior to the start of the Trump administration. However, CDRH also has seen a number of high-profile departures, including of the director of the Digital Health Center of Excellence and the deputy science director. Separately, prior to the mass reduction in force, CDRH was subject to a slate of layoffs of newer employees hired to focus on artificial intelligence (AI) and machine learning. Most of these layoffs, which were prompted by the Department of Government Efficiency (DOGE), were reversed. CDRH was also impacted by the larger reduction in force in April 2025, and we anticipate future changes to CDRH leadership and structure.
Center for Biologics Evaluation and Research (CBER). Because CBER is the center at FDA that reviews and licenses vaccines — a priority focus for Secretary Kennedy — much attention has been paid to CBER staffing. Dr. Peter Marks resigned in late March 2025, citing conflicts with leadership at HHS, and all deputy center director positions are open due to layoffs and voluntary resignations. We anticipate further changes to CBER’s leadership and structure.
Human Foods Program. In October 2024, FDA undertook a major reorganization to create its new Human Foods Program, led by a deputy commissioner for Human Foods. While nutrition and food safety are clear priorities for Secretary Kennedy, the foods program was a target of DOGE staffing cuts, which prompted the previous deputy commissioner for Human Foods to resign. The newly appointed acting deputy commissioner for Human Foods may be made permanent.
Policy Changes
Trump executive orders (EO). President Donald Trump has issued several EOs that impact FDA:
- The agency is in the midst of reviewing which of its guidance and regulations go beyond its statutory authority. (See our previous client alert.) This may implicate many proposed and final rules, as well as guidance documents.
- Another EO requires that agencies withdraw 10 guidances or regulations for every one they put out. This has led to a significant slowdown in FDA issuing guidance documents and rulemakings.
- The Make America Healthy Again Commission, which was created by EO, is chaired by Secretary Kennedy, and aims to address chronic and childhood disease. As we discussed in a recent publication, the commission includes representatives from multiple federal agencies and is expected to issue cross-cutting recommendations. The commission is tasked with issuing an assessment to the president within 100 days (by May 2025) and a more fulsome strategy within 180 days (by August 2025). The acting FDA commissioner had been participating in commission meetings prior to Dr. Makary’s confirmation, and Dr. Makary has now taken over.
Closer coordination with HHS. Prior to the large reduction in force, we had already seen a shift to FDA public communications being issued jointly with HHS and Federal Register notices being signed by Secretary Kennedy. This was a noticeable change from prior FDA practice. We now know that Secretary Kennedy’s reorganization displaced all FDA communications staff and that communications will be centralized in HHS. This change suggests that Secretary Kennedy intends to control communications from the entire HHS department, including from agencies that previously had independent communications staff.
Moving away from notice-and-comment rulemaking. Secretary Kennedy recently changed the policy for when HHS will engage in notice-and-comment rulemaking, issuing a notice in the Federal Register revoking the “Richardson Waiver,” which had previously subjected certain actions to notice-and-comment rulemaking that would otherwise be exempt. We do not yet know how FDA plans to implement this new policy, but we can expect to see the agency issuing more guidance and regulations without a notice-and-comment period.
Delaying implementation of Biden-era rules. In the last months of the Biden administration, FDA finalized many proposed rules and set implementation dates for a number of major new rules. Since the beginning of the Trump administration, FDA has delayed implementation of the traceability rule of the Food Safety Modernization Act (known as FSMA 204) for 30 months. It also put off the date for when the new Additional Condition for Nonprescription Use (ACNU) pathway for over-the-counter drugs will be available. We anticipate more delay announcements in the coming weeks and months as other impending implementation dates approach.
Reviewing the GRAS pathway. On March 10, 2025, Secretary Kennedy directed FDA to revise the GRAS final rule. As we have previously noted, this may have a wide-ranging impact on the food industry, depending on how it is implemented. Changes to GRAS could require companies currently permitted to self-affirm ingredients as GRAS, without notifying FDA, to notify FDA and provide safety data before they are permitted to introduce a new food ingredient into the food supply. Secretary Kennedy stated in a Fox News interview that his goal is for every food ingredient — even those currently on the market — to be reviewed and many of them removed from the food supply, indicating a sweeping reform of GRAS.
Operation Stork Speed (infant formula). This new initiative, announced by HHS on March 18, 2025, is aimed at improving ingredients in and transparency of labeling related to infant formula. FDA has not undertaken a formal review of infant formula ingredients since 1998. Under Operation Stork Speed, FDA will require better formula labels, increase testing for heavy metals, allow more personal importation of foreign formula and conduct health outcomes research related to formula consumption. The initiative also encourages innovation and new sources of U.S.-based formula manufacturing.
Launching the Chemical Contaminants Transparency (CCT) Tool. On March 20, 2025, FDA released the CCT Tool, a searchable database providing a consolidated list of contaminant levels (e.g., tolerances, action levels and guidance levels) that are used to evaluate potential health risks of contaminants in human foods. The database includes a broad range of chemical substances that may be present in food so consumers can assess what is in the foods they are eating.
Final Thoughts
Thus far, the policy focus at FDA has been on deregulation and improving the nation’s food supply. However, we are approaching the beginning of the reauthorization process for user fees, including the programs for prescription drugs, generics, biosimilars and medical devices, which historically has been an avenue for additional regulatory changes. We will continue to monitor for additional policy changes as they are announced.
See the Executive Briefing publication
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