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A group that represents pharmacies that have been producing off-brand versions of GLP-1 weight-loss drugs just filed another lawsuit against the U.S. Food and Drug Administration (FDA). This time, it’s over the health regulator’s decision to remove semaglutide — the active ingredient in Novo Nordisk’s (NVO+0.11%) popular Ozempic and Wegovy treatments — from its drug shortage list.
Semaglutide has been on the agency’s shortage list since March 2022. During this time, pharmacies, telehealth companies, and other healthcare providers have been able to make and sell what are known as compounded versions of the drug.
In its lawsuit, the Outsourcing Facility Association (OFA) claims that the agency is “dismissing evidence that the shortage persists” and that its decision will “deprive patients of a vital treatment.”
Semaglutide belongs to a class of drugs known as GLP-1s, which have become highly sought after for their weight loss effects. Soaring sales for these treatments have transformed Novo Nordisk and its rival Eli Lilly (LLY+2.45%), the maker of competing drugs Mounjaro and Zepbound, into the most valuable pharma companies in the world. However, Skyrocketing demand and the drugs’ high list price have made it difficult for some patients to fill their prescriptions.
Due to branded drug shortages, companies have been able to sell off-brand versions. Typically, the Food, Drug, and Cosmetic Act prohibits compounding drugs that are just copies of commercially available medications. However, drugs that are in shortage are not considered by the U.S. Food and Drug Administration (FDA) to be commercially available. Compounding means a pharmacy or physician customizes an approved drug to fit an individual patient’s needs.
The FDA also said on Friday that it will start citing companies and healthcare providers that continue to offer “essential copies” of compounded semaglutide in the next 60 to 90 days.
This is the second lawsuit the OFA has filed against the FDA over compounded weight-loss drugs. Last October, the group sued the agency over its decision to remove tirzepatide — the active ingredient in Zepbound — from its shortage list, making arguments similar to those in its latest lawsuit.
The FDA said, in a court filing, that pharmacists could temporarily resume making compounded tirzepatide as it reconsiders its decision. Then, in a letter from December, the agency stated that its review found that Eli Lilly had sufficient supply to meet and exceed both current and future demand for the drugs. This case is still ongoing.
However, not all compounders are looking to challenge the FDA on this.
“Compounding pharmacists have long known that this shortage had a shelf life,” said Scott Brunner, CEO of the Alliance for Pharmacy Compounding, in a statement.
Brunner also thanked the FDA for providing compounders with an “off-ramp” to stop production — something the agency didn’t initially offer with its tirzepatide decision.
The FDA said on Friday that state-licensed pharmacies and physicians, known as 503A compounders, must stop making and distributing semaglutide products by April 22. Outsourcing facilities, known as 503B’s, have until May 22 to do the same.
