FDA Leadership Upheaval: Makary's Departure Leaves Policy Initiatives in Limbo

FDA Commissioner Marty Makary resigned on May 12, 2026, after a 13-month tenure, triggering a cascade of senior departures and creating regulatory uncertainty for drug developers. Many initiatives that defined the Makary era were never enshrined in formal rules or guidance, but rather were announced by press release, podcast or at public events, leaving their fate in doubt under new leadership.

Kyle Diamantas, former Deputy Commissioner for Food at FDA, was named Acting FDA Commissioner. Makary had become FDA Commissioner on April 1, 2025, nominated by President Donald Trump and confirmed by the US Senate, succeeding Robert Califf.

Makary made extensive use of what is known as "podium policy": announcing significant regulatory changes through informal channels rather than through the formal notice-and-comment rulemaking process. Policies adopted outside of formal pathways are more vulnerable to reversal by future administrations and less likely to withstand judicial scrutiny. With Makary's departure and the exit of nearly all of his senior deputies, these informal initiatives carry a heightened risk of reversal or legal challenge.

The National Priority Voucher (NPV) pilot program, launched in June 2025, offers expedited one- to two-month reviews for selected drug products aligned with five national health priorities. The program has awarded 22 vouchers to date and approved seven designated products. The voucher reduces standard review times from 10 to 12 months to 1 to 2 months by using a team-based review rather than the standard review system. It does not affect pre-existing expedited review programs such as fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation. However, nearly every seat on the NPV review council is now either held by an acting official or vacant, including the positions of principal deputy commissioner as well as chief medical and science officer. The five national health priorities could be redefined entirely, or a new commissioner may decide that the program is not an appropriate use of agency resources and disband it.

In February 2026, Makary announced in a New England Journal of Medicine article his decision to make a single pivotal trial the default evidence standard for most drug approvals, a change that upended decades of regulatory precedent. This announcement was not accompanied by formal guidance or rulemaking. With Makary gone and the co-author of that article — Vinay Prasad, former director of FDA's Center for Biologics Evaluation and Research — also departed, this initiative has lost its two most prominent advocates. It is now possible that FDA will revert to requiring two trials in most cases.

During his final public appearance on May 6, 2026, Makary announced a pilot program allowing abbreviated, one-day "screening inspections" at manufacturing facilities identified as low-risk. FDA recently indicated that 46 one-day assessments had already been completed and that the program would continue through fiscal year 2026. The agency has provided limited information on how facilities are assessed for the low-risk classification beyond saying that FDA is using artificial intelligence to do so.

Makary's departure is the latest leadership change at FDA, which has had a number of executive changes since January 2025 in the two centers with regulatory oversight over the bio/pharmaceutical industry: the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). Since January 2025, there have been five changes in the head of CDER. In late April 2026, Vinay Prasad, CBER's Director, stepped down for the second time, having temporarily left the post in July 2025.

On an industry level, the Biotechnology Innovation Organization (BIO) called for stability at FDA following a period of change in leadership and staffing reductions. "What we need now is strong, stable and science-driven leadership at the FDA," said the President and CEO of BIO in a May 12, 2026, statement. "FDA must be strengthened immediately to ensure that patients continue to benefit from medical miracles and that the United States leads the world in biomedical innovation, which is crucial for the public health, economic growth and our national security."