Bengaluru: The U.S. Food and Drug Administration (USFDA) top vaccine official, Vinay Prasad, has been appointed as the agency's new chief medical and science officer, according to a report by STAT News, citing an internal memo.
Prasad is already serving as the director of the FDA’s Center for Biologics Evaluation and Research (CBER) where he supervises the regulation of vaccines, gene therapies, and other complex biologics.
The Department of Health and Human Services, which oversees the FDA, did not immediately respond to a Reuters request for comment.
Prasad will now hold three separate jobs at the agency, solidifying his position as a top adviser to FDA Commissioner Marty Makary, who announced the appointment to the staff, according to the STAT News report.
The agency's chief scientist and chief medical officer have typically been two distinct roles, as per Reuters.
The chief medical officer handles FDA's cross-cutting clinical and public health emergency-related regulatory policy matters, as well as preparedness and response activities on behalf of the commissioner.
The chief scientist provides leadership and research expertise to support innovation in public health and also oversees the regulation of cosmetic products and certification of color additives for cosmetics, food, drugs, and devices.
The roles add on to Prasad's current responsibilities as the director of FDA's Center for Biologics Evaluation and Research (CBER), where he supervises the regulation of costly and complicated biologic drugs, including vaccines and gene therapies.
Analysts had initially expressed concerns that Prasad's appointment as the CBER head would raise the bar for approval for new drugs, including what are known as accelerated approvals for potential treatments of serious conditions.
However, at a recent meeting to discuss cell and gene therapies, Prasad vowed to rapidly make therapies available at the first sign or promise of biomedical success or action.
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