“If there’s a diet, Janet McCaskill says, she’s done it. ‘I’ve tried WeightWatchers. I’ve tried keto. I’ve gone to a nutritionist,’ said the 58-year-old grandmother, who lives in Knightdale, North Carolina, outside Raleigh. Some of the eating plans worked, she said – until they didn’t,” Meg Tirrell writes over at CNN. “At the end of 2022, weighing about 212 pounds…, McCaskill started using the diabetes drug Mounjaro off-label for weight loss. It’s part of a class of drugs known as GLP-1 receptor agonists, which also includes Ozempic, Wegovy and Zepbound. ‘It literally saved my life,’ she said. But it was expensive, and after switching to a lower-cost version made by a compounding pharmacy last year, McCaskill now is worried she’ll lose access to her medication because the U.S. Food and Drug Administration determined that a shortage of the brand-name drug has ended – which means compounding of the medicine must stop. … A law allowing compounding pharmacies to step in to fill gaps when drugs are in short supply enabled thousands, or even millions, of people to access costly GLP-1 medicines at a lower price point. …For people like McCaskill, it’s been a lifeline. And as drug manufacturers dramatically ramp up supply, their access is changing fast…. A version of the drug that’s not F.D.A.-approved but which was made available legally through a local pharmacy … was less than $250 for a month’s supply. McCaskill … has been on that version since. … Last week, the F.D.A. updated its database of drugs in shortage to remove tirzepatide, which had sat on that list – along with related semaglutide-based drugs, Ozempic and Wegovy – since 2022 amid unprecedented demand. … The move means the compounding of tirzepatide, like McCaskill’s local pharmacy did, has to end. Compounding of medicines that are ‘essentially copies of a commercially available drug’ is allowed by the F.D.A. during a shortage, the agency says, but when a shortage is resolved, it’s allowed only if it’s not done ‘regularly or in inordinate amounts.'” Meg Tirrell, “The end of Mounjaro-Zepbound shortage may mean many people lose access to them,” CNN.
