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

"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."

"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."

"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."

Vinay Prasad, FDA Commissioner Marty Makary announced, will leave the agency in April after a tumultuous year. Prasad's tenure involved multiple controversial decisions including rejecting an mRNA vaccine against scientist objections, demanding additional clinical trials for a Huntington's gene therapy, publicly attacking UniQure, and creating a toxic work environment through alleged staff abuse. These actions generated significant backlash from FDA staff, the Trump administration, biotech and pharmaceutical industries, and patient advocacy groups. Financial analysts viewed his departure positively for biotech companies, particularly those in rare disease treatment. This marks Prasad's second exit from the FDA during the current administration, following his July resignation over handling of a Duchenne muscular dystrophy gene therapy.

Read at Ars Technica