Vinay Prasad Out as FDA CBER Head

Vinay Prasad, MD, MPH, who was appointed to run the FDA's Center for Biologics Evaluation and Research in May, has departed the agency, according to multiple media reports.

A spokesman for the FDA told STAT News that Prasad "did not want to be a distraction" for the agency and decided to depart and spend more time with his family.

It's unclear why Prasad departed. The move comes amid an ongoing controversy concerning Sarepta Therapeutics' Duchenne muscular dystrophy drug Elevidy.

Before joining the FDA, Dr. Prasad was a professor at the University of California, San Francisco, and held previous academic positions at Oregon Health & Science University. A hematologist-oncologist by training, he is widely published in oncology research and is the author of two books on evidence-based medicine. He also hosted the oncology podcast Plenary Session and founded The Drug Development Letter.

Dr. Prasad received his M.D. from the University of Chicago and his M.P.H. from Johns Hopkins University, with additional training at the National Institutes of Health and the National Cancer Institute.

Pharmaceutical Executive will have more on this developing story.