STAT+: Pharmalittle: We’re reading about FDA and imported GLP-1 drugs, a race to develop sleep meds, and more
Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so familiar routine of deadlines, online meetings, and phone calls has predictably returned. But what can you do? The world, such as it is, continues to spin. So time to give it a nudge in a better direction by brewing cups of stimulation. Our choice today is hazelnut creme, an old standby. Meanwhile, here are a few items of interest to start you on your journey, which we hope is meaningful and productive. Best of luck, and do keep in touch. …
The U.S. Food and Drug Administration is tightening oversight of imports of GLP-1 drug ingredients, used for weight loss and diabetes, amid concerns that many of the items may be adulterated and pose a safety risk, Reuters notes. The move comes as the FDA cracks down on unapproved compounded drugs, which had filled the gap during shortages of patented treatments. Soaring demand for obesity drugs sold by Novo Nordisk and Eli Lilly has fueled a booming global market for cheaper, and sometimes even counterfeit versions. The agency said it had previously identified serious concerns with compounded weight loss drugs, including dosing errors, use of unapproved salt forms, and side effects, with some requiring hospitalization. As part of its heightened scrutiny, the FDA sent an import alert authorizing detention without physical examination at U.S. ports. This will allow the agency to seize shipments that appear to be non-compliant with federal requirements, without inspecting them on arrival. Importers must now provide proof of quality and compliance before their goods are released. The FDA evaluated 48 manufacturing sites outside the U.S. and found 21% of them as non-compliant.
Ohio is taking steps to more tightly regulate how some large drug-compounding pharmacies in the state operate, including those making weight loss drug copies, by limiting the amount of medicine they keep on hand, Reuters explains. The move could have implications for online telehealth companies that rely on Ohio-based pharmacies producing copies in specialized doses, including one in the state owned by Hims and Hers. Telehealth companies flourished over the last year when a shortage of Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound allowed them to compound mass quantities, but are now selling what they call individualized doses. Novo and Lilly dispute that their production is legal. The Ohio Board of Pharmacy said a new regulation will target the batches large pharmacies produce in anticipation of prescriptions, limiting them to 250 units of a drug at a time. It applies to those that make sterile injectable drugs, including the popular weight loss drugs.
Ed Silverman
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