Trump's divisive FDA vaccine regulator self-destructs, will exit agency (again)

Source: Ars Technica

Overview

For the second time, Vinay Prasad is set to leave the Food and Drug Administration.

In a post on social media — see here — FDA Commissioner Marty Makary announced that Prasad will exit in April, adding that he got “a tremendous amount accomplished” during his year at the agency.

Prasad’s tenure was generally marked by controversy, but he is departing amid a cluster of self‑destructive decisions, including:

• A shocking rejection of an mRNA vaccine (Ars Technica) that went against agency scientists’ objections and was quickly reversed.
• A demand for an additional clinical trial on a gene therapy for Huntington’s disease, widely seen as moving the goalpost for the therapy.
• A public attack on the maker of that gene therapy, UniQure.
• Alleged abuse of FDA staff, who say he created a toxic work environment (Endpoints News).

These moves have roiled the agency, the Trump administration, the biotechnology and pharmaceutical industries, and patient‑advocacy groups.

On Monday, BioSpace reported that financial analysts were cheering Prasad’s departure, calling it “a big win for biotech, especially for companies in the rare disease space.” Several biotech companies that have faced setbacks and rejections at the hands of Prasad saw stock bumps on Monday; UniQure, for instance, saw its stock leap around 25 percent from Friday afternoon.

Constant controversy

This will be Prasad’s second exit from the FDA during the current Trump administration. In July, he resigned amid his controversial handling of a gene‑therapy treatment for Duchenne muscular dystrophy, as well as criticism from far‑right activist Laura Loomer, who called Prasad a “leftist saboteur.” He was reinstated less than two weeks later.

Since his return, Prasad has held key roles at the FDA: he is the chief medical and scientific officer and the director of the Center for Biologics Evaluation and Research (CBER), which also makes him the top regulator of vaccines, gene therapies, and other biologic products.

His qualifications for those roles have always been questioned. While Prasad is a professor at the University of California, San Francisco and a practicing hematology‑oncologist (a doctor specializing in blood disorders and cancers), he came to the FDA with no regulatory experience and no expertise in vaccines or gene therapies. His rise to regulatory relevance stemmed instead from his online criticism of pandemic‑era public health policies, including COVID‑19 vaccines, and his appearances on podcasts.