FDA’s top vaccine official returns to post after controversial resignation

By HPN Staff

Dr. Vinay Prasad, who resigned from his role as a top official at the U.S. Food and Drug Administration (FDA) after only three months with the agency, has returned to his post.

Prasad, a California-based hematologist-oncologist and frequent public critic of both COVID-era mandates and the FDA, was named as director of the Center for Biologics Evaluation and Research (CBER) in May of this year by FDA Commissioner Marty Makary. The CBER oversees vaccines and gene therapy. His resignation came in the wake of controversy surrounding his handling of a gene therapy for Duchenne muscular dystrophy (DMD) from Sarepta Therapeutics.

The embattled former regulator was criticized heavily, including in a Wall Street Journal editorial, for his role in the FDA’s decision to demand Sarepta Therapeutics halt shipments of the gene therapy Elevidys on July 18. The action followed three deaths out of 1,000 patients being treated for DMD, which the FDA said were linked to the therapy. 

Sarepta initially pushed back on the order, but relented shortly thereafter, citing a desire to maintain a good relationship with the agency. The FDA reversed course following pushback from patients' families and advocates, allowing Elevidys to again be delivered for use in boys with less advanced forms of DMD who still can walk. 

Prasad was also criticized for his division’s rejection of other gene therapies developed by smaller biotech firms, including a melanoma treatment developed by Replimune Group Inc., and Capricor Therapeutics Inc., which had developed a cell therapy for DMD-related heart conditions. 

Why It Matters

Prasad’s departure was seen by experts as a positive sign for the biotech industry, which chafed under his tenure, and for the advancement of innovative therapies. Analysts with Boston-based healthcare investment bank Leerink Partners wrote in a note that “With Dr. Prasad’s time as director of CBER now over, we wonder if his departure could signal a shift towards the more permissive, patient advocacy-centered ‘right to try’ wing of the MAHA movement vis-à-vis rare disease indications.”

It is unknown what his return to the FDA will mean to the biotech industry, but some have speculated it could bring regulatory volatility.

More Context

Prior to his appointment to CBER, Prasad was a professor at the University of California, San Francisco. He was a frequent critic of what he saw as the FDA’s fast-tracking of approvals for new drugs and came into favor with some on the political right for his criticism of COVID-19 vaccines and related mandates. He also shared similar views with FDA Commissioner Makary. However, he came under fire by several of President Trump's allies for his views, including previous support for progressive politics and Sen. Bernie Sanders. 

Prasad was also a vocal critic of his predecessor, Peter Marks, who oversaw an increase in the approval of gene therapies during his tenure at CBER. In his resignation letter in May, Marks said of HHS Secretary Robert F. Kennedy Jr, "truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies."

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