George Tidmarsh, director of the FDA's Center for Drug Evaluation and Research (CDER), has been appointed as the acting director of the Center for Biologics Evaluation and Research (CBER) following the abrupt resignation of Vinay Prasad. Scott Steele and Brittany Goldberg will serve as deputy directors at CBER during this transition. Prasad's departure has been linked to controversies surrounding Sarepta Therapeutics and its drug, which has faced criticism for its efficacy and safety after the deaths of two patients. Sarepta reportedly engaged the lobbying firm Michael Best Strategies and political influencer Chris LaCivita, who is associated with Laura Loomer, preceding a wave of media attacks on Prasad. Critics have accused Sarepta of manufacturing patient advocacy and promoting ineffective treatments, while Prasad was seen as a regulator committed to anti-corruption and scientific integrity. His exit highlights tensions between regulatory oversight and pharmaceutical company interests within the FDA.
Last year a parent spoke out against Sarepta’s decades of malfeasance at a patient advocacy conference Sarepta threatened to sue the group if they didn’t take the video down “Patient advocacy” is manufactured by Sarepta, it’s not real Here’s the video https://t.co/ELHkwongJU
Vinay Prasad took the job at FDA knowing that he'd be walking a tightrope and it'd be a mostly thankless jpb. He took on personal sacrifice and uprooting to go for it. In the end he was quickly and summarily fucked by the system he was supposedly called to fix.
Fake rare disease drugs, false hopes, and the rejection of science Sarepta's drug over which FDA official Vinay Prasad was axed is an absolutely horrible and worthless drug. But some are saying that it helps keep hope from patients alive, and that regulators have the