- with readers working within the Healthcare and Retail & Leisure industries
Welcome to FDA in Flux – A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies.
After the widescale firings and instability of 2025, FDA has experienced an unprecedented rate of leadership turnover since the beginning of 2026.
- The last couple of months alone have seen the departure of Vinay Prasad as Director of CBER (April 2026), Marty Makary as FDA Commissioner (May 2026), Tracy Beth Hoeg as Acting Director of CDER (May 2026), and Jeremy Walsh as Chief AI Officer (May 2026) — the latter a newly created position that now seems rudderless. Today the agency has an Acting Commissioner (Kyle Diamantas) and Acting Directors of CDER (Michael Davis), CBER (Karim Mikhail), the Human Foods Program (Don Prater), and the Center for Tobacco Products (Bret Koplow).
- There also are a large number of acting or vacant Office Director and Deputy Director positions throughout the Centers and within the Office of Inspection and Investigation (OII), which leads inspections and law enforcement activities on the ground and manages industry recalls. OII itself is led by an agency veteran, Associate Commissioner Elizabeth Miller.
- The Center for Devices remains steady under the dedicated leadership of Director Michelle Tarver.
The recent leadership changes coincided with an immediate shift in the agency's tone toward more carefully measured statements about current and developing programs. This may be related to the Acting Commissioner's background as an attorney rather than a surgeon like Dr. Makary; these two men almost certainly have completely different risk tolerances. Mr. Diamantas also appears less interested in being in the spotlight and taking credit for all agency developments. Whereas agency press releases from April 2025 to April 2026 generally would include at least one statement from former Commissioner Makary, more recent announcements feature quotes from a wider range of agency leadership. The volume of announcements from the FDA newsroom has also noticeably declined since mid-May.Further, more recent actions by FDA's leadership show some pullback from Dr. Makary's pedal-to-the-metal approach to implementing new initiatives and pilot programs, which created a constantly shifting regulatory landscape for the drug and biologic industries. For instance, the former Commissioner's race to develop multiple reforms to Phase 1 clinical trials, including real-time clinical trials (a topic in our May 2026 edition), appears to be on a longer timeline under the new leadership, as evidenced by FDA's decision to extend the comment period on a pilot program to optimize early-stage clinical trials through the use of AI.A move back toward deliberate and evidence-based regulatory decision making, along with some procedural norms such as advisory committee meetings, should be welcome news to industry stakeholders. At the same time, however, FDA's acting leadership is significantly different in terms of experience and credentials compared with previous administrations. Significant vacancies throughout leadership and line positions at the agency, coupled with the reduction of experience/institutional knowledge due to the dismissal and departure of many long-term career officials over the past 18 months, will continue to pose challenges for FDA. There are bound to be many uncertainties going forward about the new Acting Commissioner's and Center Directors' approaches to ongoing and future agency initiatives and priorities.
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