Key Points:
- Dr. Vinay Prasad resigned from the FDA just three months into his tenure amid controversy over gene therapy approvals and mounting political pressure.
- His leadership faced backlash over the Elevidys gene therapy, which was linked to patient deaths and criticized for being approved despite inconclusive clinical trial data.
- Prasad’s data-driven reforms challenged established FDA norms, but his departure leaves a leadership vacuum during a volatile moment for biologics regulation.
Dr. Vinay Prasad, the U.S. Food and Drug Administration’s chief medical and science officer and head of the Center for Biologics Evaluation and Research, has stepped down just under three months after taking office. His departure, confirmed by the Department of Health and Human Services on July 29, 2025, follows escalating controversy over the approval of a gene therapy drug and increasing political scrutiny.
A spokesperson from HHS stated, “Dr. Prasad did not want to be a distraction to the great work of the FDA in the Trump administration and has decided to return to California and spend more time with his family”. The agency expressed appreciation for the reforms Prasad introduced during his brief tenure.
Vinay Prasad was appointed in May 2025 following the ouster of longtime CBER director Peter Marks, who had overseen COVID‑19 vaccine authorizations and gene therapy reviews. Notably, Prasad was also named the FDA’s chief medical and scientific officer—an unprecedented consolidation of authority.
The Sarepta Gene Therapy Crisis
The flashpoint in Vinay Prasad’s tenure came from his handling of Sarepta Therapeutics’ controversial gene therapy drug Elevidys, approved to treat Duchenne muscular dystrophy. Following the deaths of three young patients—two in the U.S. and one in Brazil—the FDA initially suspended shipments of the therapy but reversed course days later for ambulatory patients.
Vinay Prasad had long voiced concern over Elevidys’ approval, criticizing it as being rushed despite inconclusive Phase III results. Prior to joining the agency, he publicly challenged Peter Marks’ decision to override reviewers and greenlight the therapy. His internal resistance to Elevidys while at the FDA further polarized the debate.
As the controversy unfolded, Prasad faced a barrage of political attacks. Conservative commentators accused him of undermining the Trump administration’s biotech agenda. A Wall Street Journal op-ed labeled him a “one-man death panel,” while activist Laura Loomer described him as a progressive saboteur.
Legacy, Reform, and Uncertainty
Though brief, Vinay Prasad’s time at the FDA was marked by bold attempts to recalibrate the agency’s approval standards. He restricted emergency use authorizations for COVID-19 vaccines, demanding stricter evidence thresholds, and slowed the pace of gene therapy approvals despite lobbying from rare disease advocates.
He had also sought to prioritize secondary endpoints and real-world data where applicable, walking a fine line between regulatory rigor and therapeutic access. His nuanced, data-centric approach was welcomed by some scientists but criticized by political actors for being overly cautious.
Now, his abrupt exit leaves a power vacuum in one of the FDA’s most influential arms. No successor has been named for either the CBER director or the chief medical and science officer roles. The FDA itself remains in a state of flux, with recent mass staff departures and ongoing shifts in leadership under the Trump administration.
As questions linger over the direction of biologics regulation and gene therapy oversight, Prasad’s departure highlights the increasingly politicized environment facing the FDA—a space where science, patient advocacy, and politics continue to clash.
