Ousted vaccine regulator Vinay Prasad to return to FDA

Vinay Prasad, who was recently ousted as the top vaccine and gene therapy regulator at the US Food and Drug Administration (FDA), is returning to his role, the Department of Health and Human Services said Saturday.

Prasad is returning at the FDA's request, HHS spokesperson Andrew Nixon said in a written statement. "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," Nixon said.

Prasad will resume leadership of the Center for Biologics Evaluation and Research, Nixon said. It's unclear whether he will also retake two other roles he held at the agency as chief science officer and chief medical officer.

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

FDA Commissioner Marty Makary told reporters on Monday that he was trying to persuade Prasad to return to the agency.

Though Prasad was in his role for less than three months before his ouster, he managed to stir controversy at the agency. He demanded more studies of Covid vaccines, overruled his own scientific review staff and took a confrontational approach that gave critics fodder to claim he could stymie scientific innovation.

Prasad and 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. Sarepta initially refused, then relented, leading to an outcry that the agency had overstepped.

Shares in biotech firms soared on news of Prasad's departure from the agency. His return was reported earlier by Endpoints News.