The White House on Thursday emailed HHS leadership asking for the resignation of a top aide to FDA Commissioner Marty Makary whom he had sought to promote, according to two administration officials granted anonymity to discuss a sensitive personnel matter.
Makary pushed back on the request to force policy and research staffer Sanjula Jain-Nagpal out of the agency, officials told POLITICO.
“She is an employee at the FDA, and that has not changed,” HHS spokesperson Andrew Nixon said Friday afternoon.
Jain-Nagpal, whose promotion to deputy chief of staff Makary had previously sought but which the White House had not yet approved, was previously listed in the public HHS directory as a health informatics specialist. She was no longer listed there as of Friday.
A White House spokesperson disputed the account but didn't provide more details.
The development is the latest example of tensions between Makary and leadership at HHS and the White House, which have intensified in recent weeks amid other controversies involving staff Makary brought into the agency.
It comes days after POLITICO reported that Jain-Nagpal announced on a call with FDA stakeholders that she was Makary’s deputy chief of staff, which the White House had not approved.
The two have had a close relationship at the agency. Like Makary, Jain-Nagpal was a professor at Johns Hopkins University. She is a frequent presence on Makary’s “FDA Direct” podcast.
Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, was temporarily ousted by the White House after a drug company and right-wing activist Laura Loomer campaigned to remove the hematologist-oncologist and health researcher. That followed Prasad’s push to get the drugmaker, Sarepta Therapeutics, to stop selling its Duchenne muscular dystrophy treatment due to safety concerns.
The FDA ultimately loosened restrictions on the drug, and Makary convinced White House Chief of Staff Susie Wiles to rehire Prasad to the top vaccine oversight job shortly thereafter.
Earlier this month, top drug regulator George Tidmarsh departed the FDA amid allegations that he used his position to intimidate a former business associate. Tidmarsh said he quit to protest the FDA’s handling of drug reviews. White House officials weighed scaling back Makary’s role after that development by installing a daily operations lead while keeping him as the agency’s head.
Makary has also rebuffed a request from Health Secretary Robert F. Kennedy Jr. to conduct more vaccine safety studies, POLITICO previously reported. The commissioner hasn’t yet followed through because he thinks the FDA first must develop a new system for studying vaccine side effects.
Outside groups of investors and biopharmaceutical company leaders are also sounding alarms about Makary’s stewardship, arguing he has slowed drug reviews and raised more hurdles to approval.
Earlier this week, a group calling itself No Patient Left Behind said a recent survey of biotech executives found they are worried about FDA brain drain leading to a situation where U.S. biomedical investment will shrink or be diverted to other nations.
Another coalition wrote a letter to President Donald Trump, Kennedy and Makary, arguing there has been a marked shift in how the FDA is regulating potential rare disease treatments.
“The recent wave of FDA reversals, late-cycle objections, and shifting evidentiary standards across multiple rare disease programs has led to a clear increase in unexpected [complete response letters] and refusals despite expedited designations and positive prior meetings,” the Rare Disease Advocacy, Biotechnology, and Investor Coalition wrote.
Tim Röhn and David Lim contributed to this story.
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