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 have been named deputy directors at CBER. Prasad's departure came amid controversy surrounding his decisions on treatments for Duchenne muscular dystrophy and scrutiny related to Sarepta Therapeutics' gene therapy products. Sarepta, a biopharmaceutical company, has faced criticism and regulatory pressure after patient deaths linked to its therapies. Reports indicate Sarepta engaged political consulting and media campaigns targeting FDA officials, including Prasad, contributing to a climate of distrust around the agency's regulatory processes. The situation has raised broader concerns about the FDA's handling of drug approvals and its relationship with pharmaceutical companies.
Sarepta knows they don't have to produce good science. If FDA does not approve their drugs, they launch vicious media attacks and have their propagandized patients harass FDA scientists. They have FDA by the balls. They have been doing this for a decade. It's absolutely crazy.
Let's recap last week's news with Vinay Prasad Tuesday, he suddenly departed after a series of controversial decisions about a treatment for boys with Duchenne muscular dystrophy. https://t.co/Kmy1OtSRIJ
2016 presentation given after a controversial Sarepta approval John K. Jenkins, Director, Office of New Drugs Center for Drug Evaluation and Research/FDA Jenkins resigned a month later Sarepta has been using this playbook for a decade @LauraLoomer was their latest attack dog https://t.co/LfUPSjwWQH