Dr. Vinay Prasad has abruptly resigned as the FDA’s top medical and scientific officer just months into his tenure, triggering a firestorm over gene therapy oversight and vaccine policy turmoil.
At a Glance
- Dr. Vinay Prasad resigned from his dual roles as FDA chief medical/scientific officer and CBER director.
- His tenure included a temporary suspension—and later reversal—of Sarepta’s gene therapy Elevidys.
- Prasad overruled FDA scientists to limit new COVID-19 vaccines to older and immunocompromised adults.
- Conservative figures accused him of political bias and overreach, while internal critics warned of regulatory instability.
- The Department of Health and Human Services stated he stepped down to avoid becoming “a distraction.”
Turbulence at the Top
Prasad’s meteoric rise through the FDA ranks began in May 2025 when he was appointed to lead the Center for Biologics Evaluation and Research (CBER). Just weeks later, he was promoted to the agency’s chief medical and scientific officer—a dual post placing him at the heart of vaccine and biologics policy during a politically charged era.
One of Prasad’s most controversial moves came early: halting distribution of Sarepta Therapeutics’ $3.2 million gene therapy Elevidys due to safety concerns. The move rocked the biotech industry, with patient advocacy groups and Wall Street analysts reacting swiftly. The halt was reversed after just days, but the damage—political and institutional—was done.
In parallel, Prasad diverged sharply from FDA tradition by restricting newly approved COVID-19 booster shots to older and immunocompromised individuals. This decision, made over internal objections, infuriated both pharmaceutical lobbyists and segments of the medical establishment. His critics said he was politicizing science; his defenders said he was restoring it.
Political Minefield
Prasad’s abrupt resignation followed weeks of intensifying political pressure. Far-right commentator Laura Loomer lambasted him as “deep state adjacent,” while a Wall Street Journal editorial described him as a “Bernie Sanders acolyte in MAHA drag.” Such language typified the bizarre ideological crossfire surrounding his leadership, with both conservative and liberal voices expressing discontent.
Behind the scenes, Prasad’s leadership style reportedly created tensions within FDA divisions tasked with fast-tracking biologics and vaccine reviews. Industry insiders claimed that regulatory uncertainty had already delayed several gene therapy approvals, while White House officials expressed frustration with the agency’s unpredictable direction.
Despite the rancor, FDA Commissioner Marty Makary praised Prasad as “a brilliant, courageous reformer,” adding that his exit was a personal decision motivated by family needs.
Read: US FDA’s Chief Medical and Science Officer Prasad Departs Agency
Fallout and Future Shock
With Prasad gone, the FDA faces an immediate leadership vacuum at the helm of its most consequential scientific arms. No successor has been announced, and agency watchers fear delays in high-stakes regulatory decisions on emerging genetic treatments.
Meanwhile, Sarepta Therapeutics is regaining market confidence after the Elevidys scare, but watchdog groups have renewed calls for independent review panels to assess gene therapy safety. Analysts warn that without consistent oversight, the burgeoning biotech field could veer into chaos or, worse, trigger another public trust crisis.
In the short term, Prasad’s departure resets the agency’s direction—but leaves behind lingering uncertainty. With presidential elections looming, and billions riding on the pace of vaccine and biotech rollouts, the FDA’s next move may redefine the boundaries of scientific authority in America.
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