• The White House has requested the resignation of a senior aide to FDA Commissioner Marty Makary, escalating tensions over vaccine policy and internal promotions.
  • This follows the recent dismissal of top drug regulator George Tidmarsh and comes amid ongoing disputes between Makary and Health Secretary Robert F. Kennedy Jr. over vaccine-safety studies.
  • The personnel shakeup reflects broader political pressure on the FDA's leadership and could impact regulatory stability for pharmaceutical companies.

The White House has demanded the resignation of a high-ranking aide to Food and Drug Administration Commissioner Marty Makary, according to people familiar with the matter, intensifying a period of internal conflict and political scrutiny at the agency.

The move comes as Commissioner Makary has faced obstacles in elevating policy adviser Sanjula Jain-Nagpal to deputy chief of staff, with the White House withholding approval for the promotion. Confusion persists over the actual status of the role, according to officials who spoke on condition of anonymity.

This latest personnel change follows the recent dismissal of top drug regulator George Tidmarsh, who resigned citing disagreements over drug review processes and concerns about his personal conduct. Tidmarsh's exit prompted Makary to promote longtime oncology chief Richard Pazdur to fill the vacancy.

The White House had briefly considered reducing Makary's operational oversight—a move that was later declined after intervention by Chief of Staff Susie Wiles, according to sources familiar with the discussions.

Public revelation of these changes follows reports of internal disagreements between Health Secretary Robert F. Kennedy Jr. and Makary, notably about the speed and scope of new vaccine-safety studies. Makary has advocated for developing better systems for monitoring side effects before expanding such studies, provoking frustration among some senior leadership.

Efforts to reach the FDA for comment were unsuccessful. A White House spokesperson declined to comment on personnel matters.

The FDA faces additional staffing challenges, with M. Khair Elzarrad, director of CDER's Office of Medical Policy, set to leave at month's end. The cumulative effect of these departures has created uncertainty within the agency's drug evaluation and research divisions.

Vaccine policy remains a particularly contentious area, with ongoing debates about recommendations for men aged 12-24 due to myocarditis risks. These discussions have intensified in both scientific circles and wider society, creating additional pressure on agency leadership.

The personnel shakeups come at a critical time for pharmaceutical companies awaiting regulatory decisions. Industry analysts note that leadership instability could potentially slow drug approval processes and create uncertainty for companies with products under review.

Correction: An earlier version of this article misstated the timeline of George Tidmarsh's departure. He has already resigned from his position.