Vinay Prasad to head CBER

FDA Commissioner Marty Makary has named hematologist-oncologist Dr. Vinay Prasad as the next director of the Center for Biologics Evaluation and Research.

Prasad joins the FDA from the University of California at San Francisco, where he has worked as an epidemiology and biostatistics professor since 2020. He runs the VKPrasad lab at UCSF, which studies cancer drugs, health policy and clinical trials. He now will take over for interim CBER head Scott Steele, who stepped in after Dr. Peter Marks resigned under pressure in March.

Prasad is a known public critic of the health care system’s COVID response, including mask and vaccine mandates. In 2022, Prasad and Makary were co-authors on a paper that argued that university COVID booster mandates were unethical.

Prasad has also been openly critical of Marks, including his handling of COVID vaccine approvals, as well as his decision to overrule other reviewers in the approval of Sarepta’s Duchenne muscular dystrophy treatment, Elevidys — a gene therapy that, according to Prasad, “has no evidence it helps boys.” In the same blog post, Prasad wrote that Marks was a “long-time proponent of lowering the bar for gene therapy” and “one of the most dangerous, pro-pharma regulators of the 21st century.”

As head of CBER, Prasad will now be responsible for the agency's regulation and approval of vaccines and biologics, including cell and gene therapies.