Vinay Prasad, the FDA's chief medical and scientific officer, is leaving the agency in April following a controversial tenure. His departure is welcomed by financial analysts and the biotech industry, as evidenced by stock bumps for companies like UniQure that faced setbacks under his oversight.
Prasad's time at the FDA was marked by contentious decisions, including rejecting an mRNA vaccine against scientific advice and demanding extra trials for a Huntington's gene therapy. He also faces allegations of creating a toxic work environment for staff.
This is Prasad's second exit from the FDA under the Trump administration, having briefly resigned and been reinstated last summer. His appointment to top regulatory roles was controversial due to his lack of prior regulatory or specific expertise in vaccines and gene therapies.
Main Topics: Vinay Prasad's FDA departure, controversy over his regulatory decisions, industry reaction, his qualifications and history at the agency.
For the second time, Vinay Prasad is set to leave the Food and Drug Administration.
In a post on social media Friday, 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. Those include a shocking rejection of an mRNA vaccine (which was over the objections of agency scientists and quickly reversed); a demand for an additional clinical trial on a gene therapy for Huntington’s disease, which was widely seen as moving the goalpost for the therapy; his startling choice to publicly attack the maker of that gene therapy, UniQure; and alleged abuse of FDA staff, who say he created a toxic work environment.
The moves have collectively roiled those within the agency, the Trump administration, the biotechnology and pharmaceutical industries, as well as patient advocacy groups.
On Monday, BioSpace reported that financial analysts were all but 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 were always questionable. 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. Prasad’s 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.
Meridiano
