The popular weight-loss and diabetes medication tirzepatide is no longer in short supply, the Food and Drug Administration said.
Eli Lilly's tirzepatide, sold as Zepbound for weight loss and Mounjaro to treat diabetes, has been in short supply since 2022 amid skyrocketing demand. The medication is part of the blockbuster category of weight-loss and diabetes drugs called glucagon-like peptide 1, or GLP-1.
Novo Nordisk's diabetes drug Ozempic isn't in short supply. However, shortages remain for the low-dose version of the weight-loss drug Wegovy, the FDA said.
The FDA confirmed with Eli Lilly that it has enough manufacturing capacity for tirzepatide to meet current and projected demand. However, the FDA said some patients may experience "intermittent localized supply disruptions" as the drug moves from distributors to pharmacies.
The FDA's notice means companies that make cheaper copies of tirzepatide will face new restrictions on marketing those medications. The FDA allows compounding pharmacies to sell copies of drugs when the medications are in short supply. But compounding pharmacies face stiffer restrictions when a drug shortage is resolved. The FDA said limited copies are permissible as long as they are not made "regularly or in inordinate amounts."
Compounding pharmacies are regulated by state boards of pharmacy and source ingredients are usually obtained from factories registered with the FDA. However, the federal agency doesn't verify the safety or effectiveness of compounding pharmacies.
Some consumers have flocked to telehealth providers who have sold less expensive versions of these drugs through compounding pharmacies.
Consumers and elected officials have raised concerns about the prices of GLP-1 medications, and insurance companies, some states and employers have resisted paying the full price of these drugs. Last week, a Senate committee grilled the top executive of Novo Nordisk about why the Danish company charges Americans far more for the weight-loss drug Wegovy and diabetes drug Ozempic than it does patients in Europe.
Medicare, the federal health program for adults 65 and older, is prohibited by law from covering the cost of these drugs for people who are obese but otherwise do not have serious risk factors. However, people with diabetes or heart disease may qualify for coverage.
The fact that Medicare and private insurance won't cover patients with obesity is concerning for doctors who care for these patients, said Angela Fitch, co-founder and chief medical officer of Knownwell, an obesity and primary care provider in the Boston and Dallas regions.
"Many Americans can't go to their doctor and talk about obesity or even get nutrition or lifestyle advice," because health insurers don't routinely pay for such appointments, Fitch said.