FDA ON GLP-1 DEMAND — The historic demand for a new class of weight-loss drugs is, in the view of the FDA’s top compounding pharmacy official, unprecedented. The “unusual situation,” as described by Gail Bormel, comes as the patented medications known as GLP-1s can’t be made quickly enough to meet patient need. Novo Nordisk, maker of Ozempic and Wegovy, and Eli Lilly, maker of Mounjaro and Zepbound, have bought manufacturing facilities to boost their capacity. But the shortage of semaglutide- and tirzepatide-based drugs isn’t expected to resolve before the end of the year. Compounding pharmacies make copies of the drugs for patients with valid prescriptions, a practice permitted by law when products are in shortage. But Lilly and Novo have seized on the risks of the compounds, which aren’t FDA-approved and can carry risks when not prepared properly. Here’s a snapshot of what Bormel told Lauren about that tension and what the law allows: No approximation: The FDA does not have estimates of how much compounded GLP-1 product is being consumed. That’s because the agency doesn’t require reporting by small, typically independent outfits known as 503A pharmacies that receive one-off prescriptions written by providers who know they have the equipment to make a compounded version. “We certainly don’t obtain data or receive data from the state-licensed pharmacies, but we do have data to see what outsourcing facilities are making,” Bormel said. Those outsourcing facilities, known as 503B pharmacies, must follow the FDA’s so-called current good manufacturing practices and report adverse events associated with their products. They also must report what they’re making to the agency twice a year — but the FDA cannot disclose the volumes they’re producing, Bormel said. The advertising factor: Compounders cannot claim their products are generic versions of the brand names. Novo and Lilly have sued some businesses they allege have advertised their products in a misleading way. “Generally, the agency is working closely with state regulators on this,” Bormel said. Dueling demands: The FDA tries to be Switzerland while overseeing major manufacturers and compounding pharmacies that, for now, are players for a slice of the market. While the agency “generally” recommends that consumers use agency-approved drugs, Bormel said, “We have a situation where the drugs are not available” and where compounded versions are allowed. IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. The Associated Press has some advice if you find yourself interested in scaling back the number of prescription drugs you take. Send news and tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).
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