Consumers taking copies of the popular weight loss and diabetes drug tirzepatide will likely need to find new sources of these drugs early next year.
On Thursday, the Food and Drug Administration announced that Eli Lilly’s Tirzepatide, sold as Zepbound for weight loss and Mounjaro for diabetes treatment, is no longer in short supply.
The FDA allows compounding pharmacies to sell copies of drugs if the drug is on the agency’s shortage list. Now that the FDA has determined that tirzepatide is no longer in short supply, companies must immediately stop selling copy versions of these drugs.
The FDA says pharmacies must February 18th Discontinuing the “compounding, distribution, and dispensing” of tirzepatide. Suppliers who manufacture batches of pharmaceutical products and sell them to others are March 19th Discontinue distribution.
Dae Lee, a New Jersey attorney representing the pharmacies, said the FDA’s decision “created tremendous confusion for patients, who suddenly had to start looking for brand-name drugs.”
Brand-name drugs Zepbound and Mounjaro are usually much more expensive than combination drugs.
Consumers are turning to telemedicine providers who sell cheaper copies of these drugs through compounding pharmacies. Consumers and elected officials have expressed concerns about the price of brand-name glucagon-like peptide 1 (GLP-1). medicines, and some insurance companies, states, and employers limit coverage, if any, of these medicines.
Is it possible that Ozempic and Wigoby will be taken off the shortage list?
The FDA said Novo Nordisk’s semaglutide, sold as Ozempic for diabetes treatment and Wigovy for weight loss, remains on the agency’s drug shortage list. All versions of the drug are available.
Consumers who opt for cheaper copies of Zepbound or Mounjaro because their insurance companies don’t cover GLP-1 drugs may switch to semaglutide in the short term, says a subscription-based combination product offering. said Jeff Cook, CEO of weight loss company Noom. Semaglutide.
Cook said between 1 million and 2 million Americans take GLP-1 combination drugs, and the vast majority of those patients are prescribed semaglutide. The FDA will likely remove Wegoby and Ozempic from the shortage list at some point. But Cook doesn’t believe that will happen anytime soon.
“It’s still a very uncertain situation,” Cook said.
Studies have shown that tirzepatide is more effective for weight loss than semaglutide.
Compounding industry group challenges FDA
A Lilly spokesperson said anyone marketing or selling unapproved versions of tirzepatide must stop now and begin transitioning patients to FDA-approved drugs.
The Pharmacy Compounding Alliance, which represents dispensing pharmacists and technicians, said the announcement was not unexpected but was “not necessarily the end of the story”.
“It’s unclear to me whether the data the FDA relies on in doubling down on its shortage elimination decisions is complete enough to say the shortage is truly over,” Alliance CEO Scott Brunner said in a statement. I can’t accept that at all.”
alliance Survey results have been sent Last month, the agency indicated to the FDA that hundreds of thousands of patients are taking a combined form of semaglutide (the chemical name for Wigovy), and the agency is considering semaglutide’s role in alleviating the obesity drug shortage. said it should.
Another trade group representing large compounding pharmacies sued the FDA in October over an earlier decision to remove tirzepatide from the drug shortage list.
The Outsourcing Facilities Association argues that the FDA made the decision based on Lilly’s assertion that it could meet demand for the drug without giving the public a chance to weigh in, and that the drug remains in short supply. said.
The case was put on hold a few days later after the FDA agreed to reconsider its decision, allowing the combined version to continue being sold in the meantime.
August lily has started send a cease and desist letter Telemedicine companies, wellness centers, medical spas, etc. that sell combined versions of Zepbound and Mounjaro. The company also filed a lawsuit Against sellers who falsely claim to be selling an FDA-approved version of a drug.
Reuters contributed to this report
