Vinay Prasad, M.D., has rejoined the FDA, the latest turn in a monthslong stretch of leadership turnover at the agency.

“At the FDA’s request, Dr. Vinay Prasad is resuming leadership of the Center for Biologics Evaluation and Research,” a Department of Health and Human Services (HHS) spokesperson told Fierce Pharma.

Prasad is returning to the position overseeing vaccines and cell/gene therapy regulation at the agency less than two weeks after being pushed out of the role.

Prasad’s earlier exit came as the FDA bowed to pressure from patient advocates in a regulatory showdown with Sarepta Therapeutics and after a barrage of criticism from conservatives. 

President Donald Trump ordered the removal of Prasad despite opposition from HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary, M.D., Politico reported at the end of last month, citing four people with knowledge of the decision. The HHS spokesperson did not respond to Fierce’s question about whether the president is aware of Prasad’s return.

“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,” the spokesperson added.

During a news conference Monday, Makary expressed his desire to hire Prasad back. He said reports that Prasad was fired after intervention from the White House are “simply untrue.”

Now, the question becomes how long Prasad will be able to stay at the FDA. The hematologist-oncologist lasted less than three months during his first tenure.

Prasad left the FDA after landing in the crosshairs of conservatives, including right-wing activist Laura Loomer, who reportedly has access to Trump and was responsible for the firing of several other former senior officials in the administration.  

Loomer has called Prasad a “progressive leftist saboteur” and called his appointment a “catastrophic vetting failure” within the administration. She pointed to Prasad’s past comments criticizing Trump’s “right-to-try” policies, saying that his regulatory philosophy is “fundamentally anti-Trump.”

After Makary publicly revealed that he was trying to hire Prasad back, Loomer doubled down.

“I genuinely want to know if @DrMakaryFDA thinks the White House appreciates his comments that insinuate Vinay Prasad is still welcomed in the Trump admin if *he* decides he wants his job back,” Loomer wrote in an X post on Aug. 5.

“Too many officials in the Trump admin have gone rogue to make themselves stars instead of serving AT THE PLEASURE of the President,” she continued. “It’s going to end terribly someday.”

Similarly, after Prasad’s departure, the editorial board of The Wall Street Journal called the move “welcome news.” Even though Prasad has criticized the FDA in the past, he has done so “from the left,” the editorial said before taking a shot at Makary and his pick for an interim CBER director, George Tidmarsh, M.D., Ph.D., who just recently became director of the Center for Drug Evaluation and Research.

Tidmarsh, like Prasad, has criticized the previous FDA leadership’s approval of Sarepta’s Duchenne muscular dystrophy gene therapy Elevidys. Therefore, his appointment “won’t buoy confidence in the agency,” the WSJ editorial board argued.

News of Prasad’s sudden departure broke late Tuesday, July 29. The day prior, the FDA had made a surprise move to recommend that Sarepta could resume treating ambulatory patients with Duchenne muscular dystrophy with its gene therapy Elevidys. 

It was only 10 days before that when the agency requested a pause on Elevidys shipments to all patients after reports of three non-ambulatory patient deaths from acute live failure following treatment with Sarepta’s gene therapies, including two with Elevidys and one with an experimental treatment for limb-girdle muscular dystrophy.

Rather than addressing the three patient deaths that triggered the halt, the FDA instead pointed to another death, of an 8-year-old ambulant Elevidys recipient, that was deemed to be not directly related to the gene therapy. Notably, the FDA’s release stated: “The patient community is an important voice, and the FDA will continue to listen to and respond to thoughts from the community impacted by DMD.”

Given the reported political intervention and the possible influence from patient advocates in the decision to oust Prasad, Leerink Partners analyst Mani Foroohar, M.D., recently suggested that the new CBER director would “likely to fall further along the ‘right to try’ arm of the MAHA-RFK policy side.”

A consistent regulatory approach at the FDA is necessary for the biopharma industry to thrive, Foroohar said, noting that "changing the regulatory scheme every few months is probably the most destructive approach.”