The U.S. Food and Drug Administration filled a long-vacant post on 21 July by naming Stanford adjunct professor and veteran biotech executive George Francis Tidmarsh as director of the Center for Drug Evaluation and Research. Commissioner Marty Makary said Tidmarsh’s three decades in drug development, which include leading work on seven FDA-approved medicines, will strengthen the agency’s largest division. RBC Capital Markets analyst Brian Abrahams called the appointment a pragmatic choice that could reassure drugmakers unsettled by recent staffing cuts. Tidmarsh’s hiring was followed nine days later by the abrupt departure of Vinay Prasad, the FDA’s chief medical and science officer and head of the Center for Biologics Evaluation and Research. Prasad, who joined the agency in early May, resigned after a string of contentious rulings that tightened COVID-19 vaccine clearances and halted distribution of Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy Elevidys. A Health and Human Services spokesperson said Prasad “did not want to be a distraction” and planned to return to California. The twin moves leave the FDA simultaneously shoring up its drug-review leadership while reopening a search for the top regulator of vaccines, gene and cell therapies. Industry observers say the rapid turnover underscores the political and commercial pressures facing the agency as it balances safety concerns with demands for faster approvals.
$XBI 👊👏Vinay Prasad departs FDA | STAT https://t.co/osyuF7rhqH
Vinay Prasad has hit the exit door @US_FDA. Another casualty of Laura Loomer's loyalty crusade? The $SRPT mess? It's only absolutely clear that a highly politicized agency is in turmoil. @ArmstrongDrew has the story. https://t.co/fhqSbXy8zj
Vinay Prasad, controversial FDA official, abruptly departs agency https://t.co/ZO3aczkUkT