New York, March 8 – Indian-American scientist Vinay Prasad, who oversees the approval process for vaccines and new therapies, is stepping down amid controversy over his decisions to tighten certain regulations. His departure from his position as director of the Food and Drug Administration's Centre for Biologics Evaluation and Research, for the second time within a year, was announced on Friday by the agency's head, Marty Makary.
Prasad had resigned in July, less than two months after taking the directorship, due to criticism from the right regarding his past remarks in support of Democrats. However, he was brought back in August by Health Secretary Robert F Kennedy Jr., with whom he shared some – though not all – skepticism of the medical establishment and the pharmaceutical industry.
Makary said on X that Prasad, who "achieved a tremendous amount" during his tenure, will return to the University of California, San Francisco, where he is a professor. "Under his leadership, his centre achieved 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 conflicts with pharmaceutical companies.
One recent example 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 a Dutch company, UniQure, to submit an application for a drug for Huntington's Disease, a condition that affects the brain.
While he was in academia, he criticized some of the regulations and procedures introduced by the administration of former President Joe Biden during the COVID pandemic.
That, along with his criticism of the FDA and the pharmaceutical industry, caught the attention of Kennedy.
