FDA vaccine chief leaving agency after less than 3 months

Hamilton Spectator

4 days ago

WASHINGTON (AP) — The Food and Drug Administration's polarizing vaccine chief is leaving the agency after a brief tenure that drew the ire of biotech companies, 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. The people spoke on condition of anonymity to discuss internal personnel matters.
Prasad
joined the FDA
in May after years as an academic researcher at 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 FDA Commissioner Marty Makary, who repeatedly praised Prasad's work and intellect.
But in recent weeks Prasad became a target of conservative 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.
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 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.
Prasad's predecessor in the role,
Dr. Peter Marks
, oversaw a steep 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.
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