Daijiworld Media Network - New York

New York, Mar 8: Indian-American scientist Vinay Prasad has stepped down from his role as director of the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration (FDA), marking his second departure from the position within a year amid controversies surrounding regulatory decisions.

The announcement was made on Friday by FDA Commissioner Marty Makary, who said Prasad would return to his academic role as a professor at the University of California, San Francisco.

Prasad had initially resigned in July, less than two months after assuming the post, following criticism from some right-wing groups over past comments seen as supportive of Democrats. However, he was brought back in August by U.S. Health Secretary Robert F. Kennedy Jr., who shared aspects of Prasad’s scepticism toward parts of the medical establishment and pharmaceutical industry.

Despite the controversies, Makary said Prasad achieved significant progress during his tenure, noting that the centre recorded a high number of drug approvals under his leadership.

During his time at the agency, Prasad attempted to tighten certain regulatory standards, which occasionally led to friction with pharmaceutical companies. One notable dispute involved Moderna, when Prasad blocked the company’s application for a flu vaccine over concerns about the clinical trial data. The move sparked pushback from the pharmaceutical sector, and Makary eventually overruled the decision.

Another point of contention emerged when Prasad declined an application from Dutch biotechnology firm uniQure seeking approval for a treatment targeting Huntington’s disease, a serious neurodegenerative disorder affecting the brain.

Before joining the FDA, Prasad was known in academic circles for criticising some policies introduced during the administration of former U.S. President Joe Biden, particularly those related to the management of the COVID-19 pandemic. His outspoken views on regulatory practices and the pharmaceutical industry had drawn attention from Kennedy, eventually leading to his appointment.

With his resignation, Prasad will resume his academic and research work at UCSF while debates over regulatory oversight and drug approvals within the FDA continue.