FDA Official Dr. Vinay Prasad Resigns After Three Months Amid Sarepta Gene Therapy Controversy
Key Insights
Dr. Vinay Prasad resigned from his FDA leadership position after less than three months following criticism from right-wing activists and pressure from the White House.
His departure was linked to ongoing controversy over Sarepta Therapeutics' Duchenne muscular dystrophy (search) drug Elevidys, which he had previously criticized for insufficient evidence.
The FDA recently requested Sarepta halt shipments of Elevidys after a reported death in Brazil, then reversed course to allow resumed shipments just before Prasad's resignation.
Dr. Vinay Prasad, who served as head of the FDA's Center for Biologics Evaluation and Research and later as chief medical and scientific officer, has resigned from his position after less than three months on the job. His departure comes amid mounting pressure from the White House and criticism from right-wing activists over his regulatory decisions, particularly regarding Sarepta Therapeutics' controversial gene therapy.
Sarepta Gene Therapy at Center of Controversy
The resignation follows an ongoing dispute over Sarepta's Duchenne muscular dystrophy (search) drug Elevidys, which Prasad had been a vocal critic of before joining the FDA. He argued there was insufficient evidence to show the gene therapy slowed or reversed symptoms of the rare and deadly genetic disease.
The controversy intensified this month when the FDA requested that Sarepta halt shipments of Elevidys after a reported death in a young patient in Brazil. In a surprising reversal that occurred just one day before Prasad's departure, the agency allowed Sarepta to resume shipments for certain patients.
Political Pressure and Public Criticism
According to CNN reports, Prasad faced fresh pressure from the White House to resign. Right-wing activist Laura Loomer, who has extraordinary access to President Donald Trump, publicly attacked Prasad for days on her website and social media, calling him a "progressive leftist saboteur" who was "undermining President Trump's FDA."
Loomer criticized Prasad's previous social media posts and podcast episodes, claiming he supported liberal politicians and expressed "disdain" for Trump. Her attacks were followed by criticism from other figures, including former US Senator Rick Santorum, who called Prasad "the man destroying @POTUS legacy for helping patients."
COVID-19 Vaccine Decisions Draw Scrutiny
Prasad also faced criticism from former officials and vaccine experts after internal memos revealed he overruled FDA scientists on two new COVID-19 vaccine versions in May. The FDA ultimately approved these vaccines for older and immunocompromised individuals but did not recommend them for younger Americans without underlying health conditions, following Prasad's criticism of their broad use.
Background and Qualifications
Before joining the FDA in May, Prasad served as a professor in the Department of Epidemiology and Biostatistics at the University of California at San Francisco (search) since 2020. He previously held positions at Oregon Health & Science University as a Professor of Medicine in Medical Oncology and Public Health.
A hematologist oncologist by training, Prasad has published more than 500 academic articles and authored books including "Malignant: How Bad Policy and Bad Evidence Harm People with Cancer" and "Ending Medical Reversal: Improving Outcomes, Saving Lives." He was known for being a harsh critic of some FDA drug approvals and the government's COVID-19 (search) response before his appointment.
Official Statement
A spokesperson for the US Department of Health and Human Services stated that "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."