The FDA is under fire over a recent decision to declare an end to the shortage of semaglutide and tirzepatide, the active ingredients in popular weight-loss and diabetes medications collectively known as GLP-1 drugs. The decision hurts small pharmacies while helping pharma giants like Novo Nordisk.
The explosion in popularity of GLP-1 drugs led the FDA to announce a shortage in 2022, allowing compounding pharmacies to and sell the drugs at much lower cost to consumers than branded versions such as Ozempic, the semaglutide-based GLP-1 produced by Danish company Novo Nordisk.
In October, under the Biden administration, the FDA attempted to rescind the shortage, but was blocked from doing so after a court challenge by the Outsourcing Facilities Association (OFA), a trade group that represents compounding pharmacies.
In a decision last week, a federal judge sided with the FDA, meaning smaller pharmacies must now immediately stop making compounded versions of tirzepatide, the active ingredient in GLP-1 drugs including Zepbound and Mounjaro. A separate decision on semaglutide, the active ingredient in Ozempic, is pending.
On the tirzepatide decision, OFA Chair Lee Rosebush said the group “is considering all of its options regarding the judgment, including an appeal.”
Should smaller pharmacies be forced out of the market, Big Pharma companies like Novo Nordisk will once again have a monopoly on production and supply. This is likely to raise costs for consumers, since compounded versions of the drugs tend to be sold at vastly lower prices.
This is particularly important for uninsured patients, or patients whose insurance does not cover the weight-loss drugs.
In its lawsuit against the FDA, the OFA accused the agency of “abruptly depriving patients of much needed treatment and artificially raising drug prices.”
The looming threat of an end to the official semaglutide shortage has already had major effects on telehealth companies providing compounded versions of the medication. For example, Hims & Hers Health Inc announced it would end the sale of compounded semaglutide products, causing a 27 percent drop in the company’s stock value.
Big pharma companies allege that their FDA-approved branded products are safer and more reliable than compounded alternatives. For example, a spokesperson for Eli Lilly said the recent court ruling was a welcome end to “risky, unapproved knockoffs” of Zepbound and Mounjaro, its branded tirzepatide injections.
Read more at the Hill here.
Lucas Nolan is a reporter for Breitbart News covering issues of free speech and online censorship.
