FDA vaccine chief leaving agency after less than 3 months

WASHINGTON — The Food and Drug Administration’s polarizing vaccine chief is leaving the agency after a brief tenure that drew the ire of biotech executives, patient groups and conservative allies of President Donald Trump.

Dr. Vinay Prasad “did not want to be a distraction” and was stepping down from his role as the FDA’s top vaccine regulator “to spend more time with his family,” a spokesperson for the Department of Health and Human Services said in a statement late Tuesday.

Two people familiar with the situation told The Associated Press that Prasad was ousted following several recent controversies. They spoke on condition of anonymity to discuss internal personnel matters. Prasad did not immediately respond to requests for comment Wednesday morning.

FDA’s drug center director, Dr. George Tidmarsh, will take over Prasad’s job in an acting role, according to an agency email shared with the AP. Tidmarsh started at the FDA last week after a decades-long career as a pharmaceutical executive and adjunct professor.

Prasad joined the FDA in May from the University of California San Francisco, where he frequently criticized the FDA’s approach to drug approvals and covid-19 vaccines.

His contrarian approach appeared to match that of his boss FDA Commissioner Marty Makary, who repeatedly praised Prasad’s work and intellect.

But in recent weeks Prasad became a target of right-wing activists, including Laura Loomer, who flagged Prasad’s past statements criticizing Trump and praising liberal independent Senator Bernie Sanders.

“How did this Trump-hating Bernie Bro get into the Trump admin???” Loomer posted on X last week.

Trump previously fired several national security officials a day after Loomer raised concerns about their loyalty.

Prasad also attracted scrutiny for his handling of a recent safety issue surrounding the only approved gene therapy for Duchenne’s muscular dystrophy.

Under his direction, shipments of the therapy were briefly halted after a series of patient deaths, then resumed late Monday following vocal pushback from families of boys with the fatal muscle-wasting disorder.

Prasad has long been skeptical of the therapy and other muscular dystrophy drugs sold by the drugmaker, Sarepta Therapeutics. As an academic, Prasad gained prominence by attacking the FDA for being too lenient in its standards for approving cancer drugs and other new therapies.

That approach is at odds with Trump’s Republican supporters, who generally favor speedier approvals and unfettered access to experimental treatments. During Trump’s first term he signed the “ Right to Try ” law, a largely symbolic piece of legislation that won popular support from conservatives seeking to give terminal patients expanded access to unproven drugs.

Prasad’s decision to pause Sarepta’s therapy was criticized last week by a columnist and the editorial board of The Wall Street Journal.

Separately, Prasad’s division issued three rejection letters this month to small biotech firms seeking approval for new gene therapies.

Those drugs have been vigorously embraced by many of the anti-abortion groups in Trump’s base for their potential to address intractable diseases that sometimes lead parents to terminate pregnancies.

Prasad’s predecessor in at FDA, Dr. Peter Marks, oversaw a dramatic rise in approvals for new gene therapies, which aim to treat or prevent disease by replacing or modifying a portion of patients’ genetic code.

Prasad has been an outspoken critic of Marks’ leadership at FDA, which included overseeing the approval of the first covid vaccines and therapies.