FDA vaccine chief leaving agency after less than 3 months
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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 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. The people spoke on condition of anonymity to discuss internal personnel matters. Prasad did not immediately respond to requests for comment Wednesday morning.
Prasad joined the FDA in May after years as an academic researcher at UC San Francisco, where he frequently criticized the FDA’s approach to drug approvals and COVID-19 vaccines.
His contrarian approach appeared to match FDA Commissioner Marty Makary, who repeatedly praised Prasad’s work and intellect.
These ‘experts’ sold the U.S. on a disastrous COVID plan, and never paid a professional price
They were some of the most prominent academics in the country. They pushed a devastatingly wrong COVID policy, but they’ve never admitted their error.
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 Sen. Bernie Sanders of Vermont.
“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.
Federal regulators are increasingly approving medicines before studies have shown they work, leaving patients at risk of taking prescriptions that could harm but not help them.
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 dying 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 rejection letters this month to three small biotech firms seeking approval for new gene therapies.
The baby, KJ Muldoon of Clifton Heights, Penn., is one of 350 million people worldwide with rare diseases, most of which are genetic.
Those therapies have been vigorously embraced many of the antiabortion groups in Trump’s base for their potential to address intractable diseases that sometimes lead parents to terminate pregnancies.
Prasad’s predecessor in the role, 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 the FDA, which included overseeing the approval of the first COVID vaccines and therapies.
Perrone writes for the Associated Press. The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
