FDA Vaccine Official Resigns Amid Controversy Over Policy Clashes

The top vaccine official at the U.S. Food and Drug Administration (FDA) has announced his departure after serving only three months in the role. Dr. Vinay Prasad's tenure was marked by significant disagreements with industry stakeholders and political figures, ultimately leading to his resignation. The FDA spokesperson stated that Prasad was leaving to "spend more time with his family," but sources familiar with the situation revealed that internal conflicts and recent controversies played a role in the decision.

Dr. Prasad, who joined the FDA in May from the University of California, San Francisco, was known for his critical stance on the agency's drug approval processes, including skepticism towards COVID-19 vaccine approvals. His outspoken views drew attention from various political and activist groups, especially those with conservative leanings. Notably, some activists questioned how he was appointed under the Trump administration, given his past support for Senator Bernie Sanders and criticism of President Donald Trump.

During his brief tenure, Prasad faced criticism for pausing shipments of the only FDA-approved gene therapy for Duchenne muscular dystrophy, a devastating genetic disorder affecting young boys. The shipments were briefly halted after reports of patient fatalities but were reinstated after advocacy from affected families. Prasad had previously voiced skepticism about the therapy's benefits and had questioned the approval process for similar treatments from Sarepta Therapeutics.

His approach, which favored a cautious and evidence-based approval process, conflicted with the Trump-era policies that promoted expedited access to experimental treatments. The administration had championed laws like the "Right to Try" law, enabling terminally ill patients to access unapproved treatments. Recently, the FDA under his watch also rejected several gene therapy applications from smaller biotech firms, a move aligned with his cautious stance.

Incoming acting head Dr. George Tidmarsh, a former pharmaceutical executive, is set to temporarily oversee the agency. The resignation of Dr. Prasad underscores ongoing debates within regulatory agencies regarding the balance between innovation and safety in medicine approvals.