Vinay Prasad, a prolific academic and longtime critic of U.S. drug policies, was named Wednesday as the new leader of a main Food and Drug Administration office.
FDA Commissioner Martin Makary announced Prasad’s appointment as the new director of the Center for Biologics Evaluation and Research, which oversees review of vaccines, blood products and some genetic medicines.
“Dr. Prasad brings the kind of scientific rigor, independence, and transparency we need at CBER—a significant step forward,” Makary wrote in a post on the social media site X.
In an email cited by news reports, Makary praised Prasad’s work across “a variety of public scientific, medical and academic institutions.” Currently a professor of epidemiology and biostatistics at the University of California, San Francisco, Prasad grew a social media following and platform while teaching at the Oregon Health and Science University. He runs a podcast discussing oncology research as well as a blog on the site Substack.
Prasad previously completed fellowships at the National Cancer Institute and National Institutes of Health in Hematology and Medical Oncology.
Prasad has criticized the pharmaceutical industry, the FDA and public health authorities who urged caution during the COVID-19 pandemic. Described in a STAT profile as a “professional scold,” he has levied some of his most strident criticism at pharma’s approach to cancer medicine, including accelerated approvals and precision medicine.
During the pandemic, he found fault with social distancing recommendations and some vaccine mandates, as well as called for caution using COVID vaccines in children. Controversially, he argued that some of the strongest pandemic-era measures were a prelude to totalitarianism in a blog post that invoked the Nazi party’s path to power in Germany.
However, he also criticized President Donald Trump for taking disproven medicines to prevent spread of the virus as well as refusing to use facemasks at the White House.
As CBER’s new full-time director, Prasad takes over for Peter Marks, who resigned from the FDA in March following a dispute with Health and Human Services Secretary Robert F. Kennedy, Jr. Marks had been viewed as a champion of regulatory flexibility and endorsed speedy approvals — sometimes controversially — for rare disease treatments. He also helped lead the “Operation Warp Speed” initiative that allowed the U.S. to quickly develop COVID-19 vaccines.
The announcement of Prasad’s hiring sent the XBI, an exchange traded fund that tracks the biotech sector, tumbling sharply downward. The XBI has fallen by 15% so far this year amid news of Kennedy’s downsizing of public health agencies and broader regulatory uncertainty.
Vaccine developers such as Moderna, and several companies involved in genetic medicines — including Sarepta Therapeutics, Verve Therapeutics and Prime Medicine — also saw significant sell-offs Wednesday afternoon.
