"Because of shortages of the name-brand medications - Ozempic or Wegovy for semaglutide and Zepbound or Mounjaro for tirzepatide - the FDA allowed a flood of providers to jump into the market over the past few years with cheaper, off-brand versions called compounded drugs. The FDA declared the scarcities resolved over the past year, so if people wanted to keep taking the GLP-1s, they would need to switch to the patented versions."
"Now the law seems a little less clear - or at least different interpretations of it are pushing into more gray areas. While platforms such as Ro and Weight Watchers have stopped selling and advertising compounded GLP-1s, others, such as the direct-to-consumer telehealth company Hims & Hers, have kept on keeping on. Compounders say they have found loopholes that mean they can continue to sell copycat weight-loss drugs, despite warnings from the FDA about safety and legal threats from drugmakers Eli Lilly and Novo Nordisk."
Shortages of name-brand semaglutide and tirzepatide drugs prompted the FDA to allow many providers to supply cheaper, off-brand compounded versions. The FDA later declared shortages resolved, which legally required pharmacies to stop making compounded GLP-1s and prompted transitions to patented Ozempic, Wegovy, Zepbound, and Mounjaro. Some companies halted sales and advertising of compounded formulations, while others, including Hims & Hers, continued. Compounders claim legal loopholes permitting continued sales despite FDA safety warnings and legal threats from Eli Lilly and Novo Nordisk. An estimated one million U.S. patients still use compounded GLP-1s, driven by high branded prices and limited access.
Read at Business Insider
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