Background

Currently, U.S. regulations allow companies to provide compounded versions of drugs only when the brand-name versions are in short supply. Due to their popularity, there has been a shortage of branded GLP-1 drugs since 2022.  

Last October, FDA announced that Eli Lilly's GLP-1 drug tirzepatide, which is also known by its brand names Zepbound and Mounjaro, is no longer in shortage. Later, in February, the agency announced that Novo Nordisk's GLP-1 drug semaglutide, which is branded as Ozempic and Wegovy, was no longer in shortage.

With both companies' GLP-1 drugs no longer in shortage, compounding pharmacies and other companies would no longer be able to sell compounded versions of the drugs. After announcing the ends of the shortages, FDA gave the impacted companies a facility-dependent grace period of 60 to 90 days to stop selling compounded GLP-1 drugs before the agency would take enforcement action.

The grace period for Eli Lilly's GLP-1 drug ended on March 19 while the grace period for Novo Nordisk's GLP-1 drug ended May 22.

In response to FDA's decision, organizations like the Outsourcing Facilities Association (OFA) filed lawsuits against the agency, saying that FDA wrongly trusted manufacturers' claims that they would be able to meet demand without considering evidence of patients lacking access to GLP-1 medications.

Judge rules against compounding companies

So far, U.S. District Judge Mark Pittman has sided with FDA in OFA's lawsuits against the agency.

In March, Pittman denied OFA's request for a preliminary injunction to prevent FDA from acting against companies for making compounded versions of Eli Lilly's GLP-1 drugs. Later, Pittman rejected a similar request from OFA to allow companies to continue making compounded versions of Novo Nordisk's GLP-1 drugs.

"Drug shortage determinations affect patient access to medical treatment and should be based on sound reasoning and verifiable data, not the say-so of self-interested manufacturers seeking to push competitors out of the market. We continue to hear from patients who cannot access tirzepatide," Rosenbush added. According to Rosenbush, OFA plans to file an appeal in the case. 

"The compounding law is clear," said Noom CEO Geoff Cook. "There must be an individual patient benefit to the personalization. And so Noom works with [compounding] pharmacies to provide personalized medication when it's clinically indicated."

Currently, some companies have started offering oral pills, gels, drops, and even gummy versions of GLP-1 drugs, even though none of these options are associated with an FDA-approved medication. Other companies are adding ingredients like vitamin B12, saying that they could reduce side effects.

"We have many patients on many different additives, and I think it can make a huge difference for patients in like their reported side effects and weight loss and perceived benefit," said Mochi Health CEO Myra Ahmad.

However, there is ongoing debate about whether these kinds of changes are, or should be, enough to allow companies to continue compounding GLP-1 drugs. "The plan to continue providing GLP-1s, by using these loopholes that kind of toe the line, seems to violate the spirit of" FDA guidance, said Shweta Kumar, a clinical teaching fellow in the Intellectual Property and Information Policy Clinic at Georgetown Law.

In addition, Eli Lilly and Novo Nordisk have both spoken out against compounding companies' efforts to make "personalized" formulations of their drugs.

"Compounders should have already transitioned patients to approved medicine, and anyone continuing to sell mass compounded tirzepatide, including by referring to it as 'personalized,' 'tailored' or something similar, is breaking the law and putting patients at risk," an Eli Lilly spokesperson said.

"As the FDA has warned, compounders cannot rely on mere pretextual differences between unapproved compounded drugs and FDA-approved medicines — under the guise of making 'personalized' drugs — in order to evade federal law," a Novo Nordisk spokesperson said.