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STAT+: Pharmalittle: We’re reading about Medicare and obesity drugs, FDA telling drugmakers to redo studies, and more
The Trump administration rejected a proposed rule to allow Medicare to cover blockbuster obesity drugs for weight loss alone
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 meetings, deadlines, and messages has returned. But what can you do? There is no pause button to stop the world, such as it is, from spinning. To cope, we have fired up the coffee kettle to brew another cup of stimulation. Our choice today is cinnamon churro. Please feel free to join us. Meanwhile, the time has come to dig in to the tasks at hand. On that note, we have assembled a menu of tidbits to help you get started. Hope your day is simply smashing and, as always, do keep in touch if something juicy arises. …
The Trump administration decided not to finalize a rule proposed by the Biden administration that would have allowed Medicare to cover blockbuster weight loss drugs, STAT writes. The rule would have brought in tens of billions of dollars in new sales for drugs like Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound. It also was expected to increase federal spending by $25 billion for Medicare and $15 billion for Medicaid over the next 10 years. Medicare currently covers these drugs to treat diabetes and sleep apnea and to prevent heart complications, but not for weight loss alone because it’s prohibited by law from doing so. The proposal, which former President Biden introduced at the end of his term last year, would have expanded coverage of the treatments for weight loss purposes to all people with obesity in Medicare and Medicaid programs.
In a rare move, the U.S. Food and Drug Administration told an unspecified number of drug companies that studies used to support therapeutic equivalence of some of their medicines have been rejected due to false data generated by a contract research organization, STAT tells us. The agency identified “significant” problems with data integrity and the way studies were conducted by Raptim Research, which had been hired by the drugmakers to test their medicines. The FDA expressed concern, specifically, about in-vitro studies, which are run to test biological processes. During an April 2023 inspection at Raptim facilites in Nava Mumbai, India, FDA inspectors found “objectionable conditions” that led them to conclude the company falsified data in testing for multiple subjects and samples across multiple studies, according to a letter sent to the pharmaceutical companies.
