Indian Origin Vinay Prasad Returns To FDA Within Days of Quitting

Within days of ouster from the US Food and Drug Administration (FDA) as the top  vaccine and gene therapy regulator, Vinay Prasad, is returning to his role at the FDA’s request.

Prasad, whose parents immigrated from India to the US, will resume leadership of the Center for Biologics Evaluation and Research, Department of Health and Human Services spokesperson Andrew Nixon said. “Neither the White House nor HHS will allow the fake news media to distract from the critical work the FDA is carrying out under the Trump administration,” he said.

On July 29, Prasad abruptly quit the agency after a conservative backlash in part over his handling of safety issues with Sarepta Therapeutics Inc.’s gene therapy. US President Donald Trump’s ally Laura Loomer had said Prasad was not aligned with the president’s agenda and has aggressively lobbied against his return.

It is still not clear whether Prasad will also retake two other roles he held at the agency — as chief science officer and chief medical officer.

Prasad was in his role for three months before his ouster. Controversy erupted after Prasad demanded more studies of Covid vaccines, overruled his own scientific review staff and took a confrontational approach that drew criticism that he could stymie scientific innovation.

Prasad and FDA commissioner Marty Makary asked Sarepta last month to stop shipping Sarepta’s treatment for Duchenne muscular dystrophy, Elevidys, following three deaths that were linked to the company’s gene therapies.  Following news of Prasad’s departure from the agency, shares is the biotech firms soared.