CRBC News
Politics

White House Reverses After Asking Top FDA Aide to Resign, Spotlighting Tensions at Agency

The White House asked HHS to seek the resignation of Sanjula Jain-Nagpal, an aide to FDA Commissioner Marty Makary whom he had proposed for promotion. After discussions, officials concluded she had not intentionally misrepresented a deputy chief of staff title and will keep her original role. The incident highlights growing tensions between Makary and HHS/White House leadership amid other staffing disputes and industry concerns that recent changes may slow drug reviews and harm U.S. biomedical investment.

The White House on Thursday emailed HHS leadership requesting the resignation of Sanjula Jain-Nagpal, a policy and research aide to FDA Commissioner Marty Makary whom Makary had sought to promote. After several discussions, White House officials reversed course, concluding she had not intentionally misrepresented herself and will retain her original title.

HHS spokesperson Andrew Nixon said, “She is an employee at the FDA, and that has not changed.” Jain-Nagpal had been proposed for promotion to deputy chief of staff — a move that had not yet been approved by the White House — and had previously been listed in the public HHS directory as a health informatics specialist. By Friday, her name no longer appeared in that directory.

A White House official told agency leaders that initial efforts to remove Jain-Nagpal were scaled back after discussions showed she did not directly defy orders not to claim the deputy chief of staff title, an outcome the official attributed to “communications issues.” The official said she will keep her original title.

The episode underscores growing friction between Makary and senior leadership at HHS and the White House, which has intensified amid other personnel controversies tied to Makary’s appointments.

In a related personnel dispute earlier this month, Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, was temporarily removed after pressure from a drug company and activist Laura Loomer following his call for Sarepta Therapeutics to halt sales of a Duchenne muscular dystrophy treatment over safety concerns. The agency subsequently eased restrictions on that drug, and Makary persuaded White House Chief of Staff Susie Wiles to restore Prasad to the vaccine oversight role.

Separately, senior drug regulator George Tidmarsh departed the FDA amid allegations he had used his position to intimidate a former business associate; he said he resigned in protest of how the agency handled certain drug reviews. After Tidmarsh’s exit, White House officials considered reducing Makary’s operational responsibilities by installing a daily operations lead while keeping him as commissioner.

Makary has also resisted a request from Health Secretary Robert F. Kennedy Jr. to expand vaccine safety studies, arguing the agency first needs to build a new system to study vaccine side effects.

Outside investor groups and biopharmaceutical leaders have raised alarms that recent leadership changes and policy shifts are slowing drug reviews and could prompt a “brain drain” from the FDA, potentially reducing U.S. biomedical investment. A coalition representing rare disease advocates, biotechnology firms and investors warned of “reversals, late-cycle objections, and shifting evidentiary standards” that have increased unexpected refusals and complete response letters despite expedited designations.

Contributors: Tim Röhn and David Lim.

Similar Articles

White House Reverses After Asking Top FDA Aide to Resign, Spotlighting Tensions at Agency - CRBC News