FDA vaccine chief leaving agency after less than 3 months

By MATTHEW PERRONE Associated Press Healthcare Writer 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 executives victim 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 Medical and Human Services declared in a message late Tuesday Related Articles Trump meets with candidates for four-star general in break with tradition White House acknowledges Trump announces tariff on India and unspecified penalties for buying Russian oil Watch live NTSB opens hearings on deadly Washington collision between a helicopter and client plane Howie Carr Massachusetts AG fighting crime in Paris ICE says detained Maine police officer overstayed visa The chief says he cleared a federal check Two people familiar with the situation narrated The Associated Press that Prasad was ousted following several latest controversies The people spoke on condition of anonymity to discuss internal personnel matters Prasad did not this instant respond to requests for comment Wednesday morning 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- vaccines His contrarian approach appeared to match FDA Commissioner Marty Makary who repeatedly praised Prasad s work and intellect But in contemporary 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 safety functionaries a day after Loomer raised concerns about their loyalty Prasad also attracted scrutiny for his handling of a up-to-date 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 subject 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 decree that won popular sponsorship 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 Those therapies have been vigorously embraced several of the anti-abortion groups in Trump s base for their prospective 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 affection 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 The Associated Press Healthcare and Science Department receives promotion from the Howard Hughes Diagnostic Institute s Department of Science Tuition and the Robert Wood Johnson Foundation The AP is solely responsible for all content