
The US Food and Drug Administration has named Vinay Prasad, an oncologist who has been a prominent critic of the Food and Drug Administration and COVID-19 mandates, as the director of its Center for Biologics Evaluation and Research, the agency said.
Prasad, who has frequently criticised the pharmaceutical industry, will oversee the regulation of costly and complicated biologic drugs, including vaccines and gene therapies, the news agency Reuters reported. He succeeds Peter Marks, who oversaw the approval of COVID-19 vaccines and resigned in March after clashing with Health Secretary Robert F. Kennedy Jr. over concerns about the safety of vaccinations.
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Prasad’s appointment raises new questions about whether vaccines and other new therapies will face unnecessary scrutiny from regulators.
FDA Commissioner Dr. Marty Makary announced the appointment Tuesday in a message to agency staff, praising Prasad’s “long and distinguished history in medicine”.
Prasad’s appointment is likely to rattle drug and vaccine makers, who depend on the predictability of FDA standards and procedures to guide drug development plans that can span years or even decades.
Prasad, a professor at the University of California, San Francisco, has medical training in cancer and blood disorders. During the COVID-19 pandemic, Prasad critcised vaccine, mask mandates and lockdowns.