Article Summary:
The article discusses recent developments at the FDA, including the resignation of the head of the Center for Drug Evaluation and Research (CDER), George Tidmarsh, amid a lawsuit and allegations of misconduct. Tidmarsh reportedly had a “longstanding personal vendetta” against a healthcare investor, Kevin Tang, and was accused of trying to tank the stock price of a drug company he was critical of. His resignation has created “total disarray and a complete lack of functional leadership” at the agency, according to experts.
Despite the leadership turmoil, FDA Commissioner Marty Makary has claimed the agency remains strong and will meet its targets. The agency has added six new drugs to its Commissioner’s National Priority Voucher pilot program, which provides accelerated review. The FDA has also been active in other areas, issuing warning letters to companies illegally marketing unapproved botulinum toxin products, as well as citations for manufacturing violations.
The text also covers FDA regulatory actions, including the approval of a novel treatment for Barth syndrome despite reviewers’ recommendations against it, as well as the agency’s concerns about the data for a gene therapy for Huntington’s disease. Additionally, the agency has granted an extension for the review of a supplemental new drug application, and is scheduled to discuss a first-of-its-kind medical device for heart failure patients.
Overall, the text paints a picture of an FDA grappling with significant leadership challenges, even as it continues to carry out its core regulatory responsibilities across the drug and medical device sectors.