After exiting the FDA less than two weeks ago for unclear reasons, Vinay Prasad is once again director of the Center for Biologics Evaluation and Research, HHS confirmed to several outlets Saturday.
He’s back! Not two weeks after news broke that Vinay Prasad would depart as chief of the FDA’s Center for Biologics Evaluation and Research, the regulator has apparently convinced him to return.
“At the FDA’s request, Dr. Vinay Prasad is resuming leadership of the Center for Biologics Evaluation and Research,” Health and Human Services spokesman Andrew Nixon told STAT News on Saturday.
Steven Grossman, policy and regulatory consultant and author of the FDA Matters blog, shared his thoughts on Prasad’s return in an email sent to BioSpace and other outlets Saturday. “It takes time for an outside critic to turn into an inside decisionmaker. So, I am guardedly optimistic that he is returning chastened by the realization that neither the CBER director nor the FDA commissioner can make decisions in a vacuum. Lives are at stake. There are multiple stakeholders, notably patients and companies, as well as the President and Congress. They are all paying attention.”
The reasons behind Prasad’s exit on July 29 have been murky, though the move followed a campaign by conservative personalities, including Laura Loomer, to get rid of the CBER chief. On her website last month, Loomer claimed that Prasad was a “progressive leftist saboteur” working to undermine President Donald Trump’s agenda within the FDA. Prasad’s departure also followed closely on the heels of Sarepta Therapeutics’ rollercoaster month that saw the FDA compel the biotech to halt all shipments of its gene therapy for Duchenne muscular dystrophy, Elevidys, after the deaths of two teenage patients, and a third death of a participant in a trial for the company’s investigational limb-girdle muscular dystrophy gene therapy, which also uses an AAV vector.
“Dr Prasad did not want to be a distraction to the great work of the FDA in the Trump administration,” an HHS spokesperson told Endpoints News on July 29 when confirming his departure, adding that the physician had “decided to return to CA and spend more time with his family.”
However, on Saturday, an HHS spokesperson struck a different tone, telling Endpoints, “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 publication reported earlier this week that FDA Commissioner Marty Makary said he wanted Prasad—a long-time academic collaborator—to return to his role at the FDA, and that it was “untrue” that he was pushed out of his role, and that, in fact, he had resigned.
“We have encouraged him to reconsider and we’re still doing that,” Makary said at a Monday event in Washington, according to Endpoints.
In June, Prasad was also named as the FDA’s chief medical and scientific officer. It is unclear at this time whether he will also resume those roles. BioSpace has reached out to HHS for independent confirmation and further information on these and other details.
