Companies will take 60 to 90 days to phase out products.
Specialty pharmacies and online companies that have been selling off-brand copies of two blockbuster drugs for obesity and diabetes will have to phase out their versions next year under a federal government decision issued Thursday.
The Food and Drug Administration announced that a nationwide shortage of Eli Lilly’s Zepbound and Munjaro has been eliminated, eliminating the need to buy copycat versions of the drugs that have become wildly popular among Americans looking to lose weight.
The decision is a victory for Lilly, which has been pressuring the FDA for months to take action, and is expected to impact how patients access the drug, including how much they pay.
Zepbound is FDA-approved to treat obesity, and Mounjaro is approved to treat diabetes. It uses the same active ingredient, tirzepatide.
The FDA announced Thursday that after two years of shortages, “Lily’s supply currently meets or exceeds demand.”
Both drugs are part of the GLP-1 class and have shown unprecedented results in aiding weight loss by reducing appetite and increasing satiety. Novo Nordisk’s competing drugs Wigovy and Ozempic remain on the FDA’s shortage list.
As demand for GLP-1 drugs soars, compounding pharmacies and telemedicine companies such as Hims and Ro have entered the market, selling cheaper versions online. You can usually get a month’s supply for a few hundred dollars.
Thursday’s decision gives companies 60 to 90 days to phase out products, depending on their size.
The FDA allows compound versions of brand-name drugs when there is a shortage, and a return to Lilly’s drug could improve consumer safety. Last year, the FDA warned patients that some GLP-1 drugs sold online had problematic ingredients and formulations. The agency has limited oversight of compounding pharmacies, which are primarily overseen by state authorities.
Compounding pharmacies use raw drug ingredients to manufacture customized versions of prescription drugs, such as when a patient has an allergy to a particular ingredient. The industry has grown into a multibillion-dollar business over the past decade as drug shortages worsen.
Demand for off-brand GLP-1 drugs is amplified by aggressive online promotion by telemedicine companies, which are not subject to the same marketing rules as pharmaceutical companies.
The FDA previously declared shortages of Mounjaro and Zepbound eliminated in early October, but reversed the decision after public outcry and lawsuits by compounding pharmacies.
