Indian-American scientist Vinay Prasad quits FDA role again amid pharma clashes
Indian-American scientist Vinay Prasad has stepped down for the second time as director of the FDA’s Center for Biologics Evaluation and Research within a year. His tenure saw record approvals but also sharp disputes with pharmaceutical companies, including Moderna and UniQure, over trial standards.
New York: Indian-American scientist Vinay Prasad, who oversees the approval process for vaccines and new therapies, is stepping down amid controversies over his decisions to tighten certain regulations. His departure for the second time from the post of director of the Food and Drug Administration’s Centre for Biologics Evaluation and Research within a year was announced on Friday by the agency’s head, Marty Makary.
Prasad had quit his job in July, less than two months after taking the directorship, due to criticism from the extreme right regarding his past remarks in support of Democrats. But he was brought back in August by Health Secretary Robert F Kennedy Jr, with whom he shared some – though not entire – scepticism of the medical establishment and the pharmaceutical industry.
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Makary said on X that Prasad, who “got a tremendous amount accomplished” during his tenure, will return to the University of California, San Francisco, where he is a professor. “Under his leadership, his centre hit a record number of approvals” of medications, he added.
Although he loosened some of the trial requirements for therapies, such as requiring only one major study instead of two, the types of trials he demanded created run-ins with pharmaceutical corporations.
A recent one was with Moderna when he blocked its application for releasing a flu vaccine, questioning its trials. The company and others in the pharmaceutical industry fought back, and Makary overruled Prasad.
Another controversy was over his refusal to allow an application from the Dutch company UniQure for a drug for Huntington’s Disease, an ailment that affects the brain.
While he was in academia, he criticised some of the regulations and procedures introduced by the administration of former President Joe Biden during the COVID pandemic.
That and his criticism of the FDA and the pharmaceutical industry caught the attention of Kennedy.
