Article Summary:
FDA took several notable actions this week across drugs and medical devices. In an unusual move, a senior FDA official publicly criticized UniQure’s Huntington’s disease gene therapy data as “distorted” and “manipulated” during an agency-arranged media call—a rare occurrence that may create political complications for the Trump Administration.
State representatives met with FDA to discuss the Section 804 importation program, which allows importing cheaper prescription drugs from Canada, aligning with President Trump’s executive order on drug prices. Additionally, FDA issued 30 warning letters to telehealth companies for misleading marketing of compounded GLP-1 products.
In enforcement actions, former ExThera Medical executive Sanja Ilic agreed to plead guilty to defrauding FDA by failing to report adverse events related to blood filtration devices.
FDA approved several significant drugs: Janssen’s Tecvayli combination for multiple myeloma (the third approval under the new Commissioner’s National Priority Voucher pilot program, processed in just 55 days), the first generic version of GlaxoSmithKline’s Flovent HFA asthma inhaler, and Ascendis Pharma’s Yuviwel for achondroplasia in children.
On the medical device front, FDA held MDUFA VII negotiations with industry, published updated lists of AI-enabled and digital health devices, and recommended using established choking rescue protocols before anti-choking devices. Medline issued a Class I recall for reprocessed catheters due to contamination risks.
FDA also published international guidance documents and announced upcoming workshops on generic drug science and pediatric cell and gene therapy trials.