Consumers who take copies of the popular weight loss and diabetes drug tirzepatide will likely need to find a new source for these medications early next year.
On Thursday, the Food and Drug Administration said Eli Lilly's tirzepatide, sold as Zepbound for weight loss and Mounjaro to treat diabetes, is no longer in short supply.
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The FDA allows compounding pharmacies to sell copies of drugs when the medications are on the agency's shortage list. Now that the FDA has decided tirzepatide is no longer in shortage, companies must soon stop selling copied versions of these drugs.
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The FDA said pharmacies have until Feb. 18 to discontinue "compounding, distributing or dispensing" tirzepatide. Suppliers that produce batches of the drug and sell to others have until March 19 to cease distribution.
The FDA's decision creates "a lot of confusion for patients, and now they suddenly have to start looking for branded medications," said Dae Lee, a New Jersey attorney who represents pharmacies.
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The branded drugs, Zepbound and Mounjaro, are typically much more expensive, than the compounded versions.
Consumers have turned to telehealth providers who sell less expensive copies of these drugs through compounding pharmacies. Consumers and elected officials have raised concerns about the prices of brand-name glucagon-like peptide 1, or GLP-1. medications, and some insurance companies, states and employers have limited, if any, coverage of these drugs.
Could Ozempic and Wegovy come off the shortage list?
The FDA said Novo Nordisk's semaglutide, which is sold as Ozempic to treat diabetes and Wegovy for weight loss, remains on the agency's drug shortage list even though all versions of the drug are available.
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Consumers who choose less expensive copies of Zepbound or Mounjaro because their insurance company does not cover GLP-1 drugs might switch to semaglutide in the short-term, said Geoff Cook, CEO of Noom, a subscription-based weight-loss company that offers compounded semaglutide.
Cook said 1 to 2 million Americans take compounded GLP-1 medications, and the vast majority of those patients are prescribed semaglutide. The FDA will likely take Wegovy and Ozempic off the shortage list at some point. but Cook does not believe that will happen soon.
"It remains a very murky situation," Cook said.
Studies have found tirzepatide to be more effective than semaglutide for weight loss.
Compounding industry groups challenge FDA
A Lilly spokesperson said anyone marketing or selling unapproved versions of tirzepatide must now stop and begin transitioning patients to FDA-approved medicines.
The Alliance for Pharmacy Compounding, which represents compounding pharmacists and technicians, said the announcement was not unexpected but "not necessarily the end of the story."
"I’m just not persuaded that the data on which FDA is relying in this doubling-down on its shortage resolution decision is complete enough to say the shortage is really over," said Alliance CEO Scott Brunner.
The Alliance sent survey results to the FDA last month showing hundreds of thousands of patients were taking compounded versions of semaglutide, the chemical name for Wegovy, and said the agency should consider their role in alleviating the obesity drug supply crunch.
Another industry group that represents larger compounding pharmacies sued the FDA in October over an earlier decision to take tirzepatide off its list of drugs experiencing shortages.
The Outsourcing Facilities Association claimed the FDA had made its decision based on Lilly's claims that it could meet demand for the drugs, without giving the public a chance to weigh in. It said that the drug remained in short supply.
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The lawsuit was put on hold days later after the FDA agreed to reconsider the decision, allowing sales of compounded versions to continue in the meantime.
Lilly in August began sending cease-and-desist letters to telehealth companies, wellness centers and medical spas selling compounded versions of Zepbound and Mounjaro. The company has also filed lawsuits against sellers falsely claiming to sell FDA-approved versions of the drug.
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