The Food and Drug Administration on Wednesday declared an end to the two-year shortage of tirzepatide, the substance in the popular weight-loss medication Zepbound and the diabetes drug Mounjaro. The end of the shortage means that far more people could soon be able to access the brand-name drugs. But it is also certain to disrupt the big business of compounded weight-loss drugs, forcing many patients off copycat medications that can only be made when brand-name drugs are in short supply.
Many people have not been able to get their hands on the brand-name medications since 2022, shortly after Mounjaro was first introduced in the United States. Demand for the drug was so great that it quickly went into short supply. That drove patients to seek out alternatives from compounding pharmacies — which, during shortages, can create their own versions of medications that do not have to be approved by the F.D.A. By some estimates, millions of Americans have taken compounded weight-loss and diabetes drugs.
Now that the shortage is resolved, pharmacies must immediately stop preparing compounded copies of Mounjaro and Zepbound, said Scott Brunner, the chief executive of the Alliance for Pharmacy Compounding.
“There are many, many, many more patients than normal who are relying on compounded copies of F.D.A.-approved drugs,” he said. “It’s those folks that are going to have to scramble.”
Compounding pharmacies have historically tailor-made drugs for patients with specific needs, like reformulating a pain reliever if someone is allergic to one of its ingredients. But they have taken on a far more prominent role as demand has soared for diabetes and weight-loss drugs. The interest in these compounded drugs has largely been fueled by upstart telehealth companies like Ro and Hims, which advertise access to them for hundreds of dollars less than the name-brand medications.
“Compounding pharmacies have been around for a long time, but there’s never been this confluence of this massive increase of telehealth providers after Covid-19 for a blockbuster drug,” said Timothy Mackey, a professor at the University of California, San Diego, who has studied the counterfeit weight-loss drug market.
That these companies will no longer be able to offer compounded versions of tirzepatide is a victory for its maker, Eli Lilly, which lost a share of the market for these medications to compounding pharmacies as it struggled to keep up with demand. The company has poured money into increasing its manufacturing capacity, including a $9 billion investment to increase production of tirzepatide and other drugs.
“The entities currently mass-producing and mass-marketing compounded and counterfeit tirzepatide need to stop immediately,” Eli Lilly, the maker of Zepbound and Mounjaro, said in an emailed statement.
While the end of the shortage means the drugs will be more widely available, many patients had turned to compounded options because they cost less than the brand-name drugs. Some still may not be able to afford brand-name Mounjaro or Zepbound.
The F.D.A. also noted that there might still be intermittent problems with availability as products move through the supply chain.
“I don’t think this announcement is going to equal immediate access for people,” said Lindsay Allen, a health economist at Northwestern Medicine.
Still, Shabbir Imber Safdar, the executive director of the Partnership for Safe Medicines, said that “the end of the shortage means an enormous reduction in patient risk.” The F.D.A. has repeatedly warned that these unauthorized medications have been linked to serious health concerns, including overdoses.
It’s not clear how quickly compounding pharmacies and telehealth companies will move to adjust their practices or stop offering compounded copies of these drugs.
A spokesperson for Ro wrote in an email that the company is “working to ensure our patients have the best options available to them to preserve continuity of care.”
Some patients may have no choice but to go off the medicine altogether. Those using compounded tirzepatide will likely gain weight if they stop taking the drug, said Dr. Melanie Jay, the director of the N.Y.U. Langone Comprehensive Program on Obesity.
Compounders and telehealth companies will still be able to offer compounded versions of semaglutide, the substance in Ozempic and Wegovy, as it remains in shortage. Technically, compounding pharmacies could also still customize versions of tirzepatide for certain patients if they needed unique formulations, such as to avoid an allergy.
Geoff Cook, the chief executive of Noom, which does not offer compounded tirzepatide but does prescribe compounded semaglutide, said the company was exploring the idea of “personalized treatments” for its compounded offerings once semaglutide was no longer in shortage.
In announcing the end of the tirzepatide shortage, however, the F.D.A. reiterated that pharmacies could not compound a commercially available drug “regularly, or in inordinate amounts.”
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