FDA reinstates ousted top vaccine regulator Vinay Prasad

Vinay Prasad, a top vaccine regulator ousted from the Food and Drug Administration (FDA) late last month, is set to return to his post, according to the Department of Health and Human Services (HHS).

"At the FDA’s request, Dr. Vinay Prasad is resuming leadership of the Center for Biologics Evaluation and Research," an HHS spokesperson told The Hill in a 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."

Prasad’s July 30 resignation as the FDA's chief science officer followed criticism from right-wing figures — including activist Laura Loomer and former Sen. Rick Santorum (R-Pa.) — that ran parallel to a regulatory showdown with drug manufacturers over a gene therapy treatment for boys with Duchenne muscular dystrophy.

Loomer, a key ally of President Trump with noticeable influence, lavished attacks on the FDA official in recent weeks — calling him a "saboteur" and "trojan horse" for HHS's "Make America Healthy Again" initiative.

Prasad was named head of the FDA’s Center for Biologics Evaluation and Research in early May as a replacement for Peter Marks, who resigned from the position in March after clashing with HHS Secretary Robert F. Kennedy Jr.

The doctor, just one of several health officials tapped by Trump who criticized COVID-19 vaccines, had been in the role for less than three months when the FDA announced he would step down.

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

The division at the time was also involved in a dispute between the administration and Sarepta Therapeutics. The FDA had paused shipments and clinical trials of its Elevidys treatment for those with Duchenne muscular dystrophy following reports of two patients that died after receiving the drug.

Prior to his role in the administration, Prasad had argued against the treatment's approval after Marks overrode multiply agency reviews.

He also recently made headlines for restricting the approval of two COVID-19 vaccines while disregarding recommendations from government scientists. Two memos issued last month by the FDA showed how the doctor personally intervened to place limitations on drugmakers Novavax and Moderna after their coronavirus shots were approved for anyone 12 years or older.

Nathaniel Weixel contributed reporting.