The U.S. Food and Drug Administration's top official, Vinay Prasad, has left the agency after nearly three months as Director of the Center for Biologics Evaluation and Research, a government spokesperson said late on Tuesday.
Prasad, an oncologist who previously criticized the FDA and was a fierce critic of U.S. COVID-19 vaccine and mask mandates, had been appointed in May.
"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," a spokesperson from the Department of Health and Human Services told Reuters in an emailed statement.
Endpoints News first reported Prasad's departure.
His exit comes after a number of unusual regulatory actions, including those taken recently by the agency on Sarepta Therapeutics' gene therapy, Elevidys.
"Unprecedentedly, there were multiple press leaks from the FDA, negatively impacting (its) credibility," said BMO Capital Markets analyst, Koustas Billouri.
During Prasad's short stint, the U.S. FDA limited the use of COVID-19 vaccines and declined to approve therapies from Replimmune and Capricor Therapeutics.
The regulator's decisions under Prasad raised concerns that he was anti-patient choice, Jefferies analyst Roger Song said, adding that investors will see his departure as a positive for gene therapy and vaccine makers.
The Nasdaq Biotechnology Index declined 7% on Prasad's appointment, but has since recovered. Shares of Replimmune rose 58%, Sarepta was up 11.2% and Capricor added 21.2% in premarket trading on Wednesday.
Prasad also held the additional role of the agency's chief medical and science officer, to which he was appointed last month, according to STAT News.
Nominating a more seasoned official to replace him could help the FDA rebuild its credibility, BMO's Billouri said.