
"FDA Commissioner Marty Makary announced the news to FDA staff in an email late Friday, saying Prasad would depart at the end of April. Makary said Prasad would return to his academic job at the University of California, San Francisco. In July, Prasad was briefly forced from his job after running afoul of biotech executives, patient groups and conservative allies of President Donald Trump."
"Prasad's latest ouster follows a string of high-profile controversies involving the FDA's review of vaccines, gene therapies and biotech drugs in which companies have criticized the agency for reversing itself, in some cases calling for new trials of products previously greenlighted by regulators."
"First, Prasad initially refused to allow the FDA to review a highly anticipated flu vaccine from drugmaker Moderna made with mRNA technology. The rejection of the application, highly unusual for the FDA, prompted Moderna to go public with Prasad's decision and vow to formally challenge it. A week after the rejection became public, the FDA reversed course and said it would accept the shot for review after all."
Dr. Vinay Prasad, the FDA's vaccine chief, is leaving the agency at the end of April to return to his academic position at the University of California, San Francisco. This marks his second departure in less than a year. Prasad was previously forced out in July but reinstated within two weeks with support from Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary. His latest departure follows multiple high-profile controversies involving FDA reviews of vaccines, gene therapies, and biotech drugs. Recent disputes include initially refusing to review Moderna's mRNA flu vaccine before reversing course, and engaging in a public conflict with UniQure over an experimental Huntington's Disease treatment. Pharmaceutical executives, investors, and members of Congress have criticized Prasad's decisions.
#fda-leadership #vaccine-regulation #biotech-controversy #drug-approval-process #regulatory-reversal
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