Who is Vinay Prasad? US FDA's top regulator exits agency after controversy over Sarepta gene therapy

Dr Vinay Prasad, a top regulator at the US Food and Drug Administration, has resigned in less than three months in the job following a controversy over the handling of Sarepta Therapeutics Inc.'s gene therapy.

“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,” CNN quoted a spokesperson for the US Department of Health and Human Services as saying.

Who is Vinay Prasad?

In May, Prasad, a haematologist and oncologist, was appointed head of the FDA’s Centre for Biologics Evaluation and Research, granting him authority over vaccines and biological medicines. Subsequently, he was also appointed the FDA's chief medical and scientific officer. Similar to several Trump administration health appointees, Prasad had been a vocal critic of the government’s response and vaccine policies during the COVID-19 pandemic.

Vinay Prasad's resignation

The report, citing people aware of the development, said Prasad resigned amid pressure from the White House. Additionally, Laura Loomer, a right-wing activist known to have close ties with Donald Trump, consistently criticised Prasad. She publicly criticised him for days on her website and social media, calling him a “progressive leftist saboteur” who was “undermining President Trump’s FDA.”

Loomer called out Prasad’s previous social media posts and podcast episodes, where she claimed that he supported liberal politicians and expressed “disdain” for Trump.

However, FDA Commissioner Dr Marty Makary defended Prasad just days ago. In an interview with Politico, Makary said Prasad is an “impeccable scientist … one of the greatest scientific minds of our generation.”

“We thank him for his service and the many important reforms he was able to achieve in his time at FDA,” the spokesperson for HHS said.

Sarepta gene therapy controversy

Prasad took on his role at the FDA following years of outspoken criticism of certain drug approvals by the agency. Notably, he condemned the approval of Sarepta’s Duchenne muscular dystrophy drug, Elevidys, asserting that there was insufficient evidence to demonstrate it effectively slowed or reversed symptoms of this rare and deadly genetic condition.

This month, the FDA asked Sarepta to stop shipments of the drug after a reported death of a young patient in Brazil. Just one day before Prasad’s departure, the agency unexpectedly reversed its decision and allowed Sarepta to continue shipments for certain patients.

Prasad faced criticism from former officials and vaccine experts after May's internal memos showed he overruled FDA scientists on two new Covid-19 vaccine versions. The then-CDER director criticised the broad use of these vaccines; ultimately, the FDA approved them for older and immunocompromised individuals but did not recommend them for younger Americans without underlying health conditions.