Drug compounders sue FDA for removing Novo Nordisk’s Ozempic, Wegovy from shortage list
The Outsourcing Facilities Association, an industry group representing drug compounders, filed a lawsuit on Monday against the FDA for its decision last week to remove Novo Nordisk’s blockbuster medications Ozempic and Wegovy from the agency’s shortage list.
The lawsuit, filed in federal court in Fort Worth, Texas, follows on the heels of last week’s decision by the FDA to reclassify the shortage of Novo Nordisk’s semaglutide — marketed as Ozempic for type 2 diabetes and as Wegovy for obesity — as “resolved” per its database.
The plaintiffs, which include Texas-based FarmaKeio Superior Custom Compounding, called the FDA’s decision “reckless and arbitrary” in Monday’s lawsuit, warning that it will “deprive patients of a vital treatment for type 2 diabetes, obesity, cardiovascular disease, and other serious medical conditions.”
The FDA “arbitrarily” dismissed evidence that the semaglutide shortage persists and removed it from the agency’s shortage list “without notice-and-comment rulemaking, in contravention of its statutory directive, and without evidentiary support,” according to the legal complaint.
The lawsuit alleges that the FDA “credited undisclosed evidence” from Novo Nordisk “but that evidence could not have credibly showed the end of the shortage because manufacturer representatives have informed their own shareholders that supply constraints and shortage persist.” The plaintiffs are asking the court to “vacate and/or set aside” the FDA’s decision removing semaglutide from its drug shortage list.
In December 2024, the FDA similarly issued a decision reconfirming that the shortage of Eli Lilly’s tirzepatide — the active ingredient in its type 2 diabetes and obesity drugs, Mounjaro and Zepbound — was resolved. In October, the agency announced that it was rethinking the shortage status of Lilly’s tirzepatide, which the regulator removed from its shortage list earlier in the month, after a lawsuit was filed by the Outsourcing Facilities Association and FarmaKeio. However, in the end, the FDA stood by its initial decision on tirzepatide.
With the lifting of the shortage for both semaglutide and tirzepatide, the FDA said that compounders will have a grace period of 60 to 90 days before the regulator enforces rules that would put an end to their making off-brand copies of the drugs.
Can Lilly, Novo Nordisk keep up with demand?
Both Lilly and Novo Nordisk have invested billions of dollars to ramp up their respective manufacturing capabilities to try and keep up with the unprecedented demand for their type 2 diabetes and obesity medications.
Lilly CEO David Ricks told investors earlier this month that the company’s tens of billions of dollars of investment to meet the increasing demand for its wildly popular type 2 diabetes and obesity drugs, Mounjaro and Zepbound, is paying off.
“Since 2020, our commitments to build, expand, and acquire manufacturing facilities now total more than $23 billion,” Ricks said during Lilly’s Feb. 6 earnings conference call. “The incretin market continues to grow rapidly, and Mounjaro and Zepbound are both gaining share of market.”
However, Lilly acknowledged in its annual report last week that there were “periods of 2024” when demand for the company’s incretin medicines exceeded production and while the supply of tirzepatide currently exceeds demand in the U.S., it’s a situation that remains dynamic.
In December 2024, Novo Nordisk announced that the $16.5 billion acquisition of Catalent by Novo Holdings and the related $11 billion acquisition by the Danish drugmaker of the three manufacturing sites from Novo Holdings was completed. Located in Italy, Belgium and Indiana, the sites are meant to boost the production of Novo Nordisk’s Ozempic and Wegovy.
“Our expanding global production network is operating around the clock to ensure a stable and consistent supply of Wegovy,” according to Novo Nordisk’s annual report released earlier this month, which described the “unprecedented” demand for its GLP-1-based medicines, while acknowledging that “production capacity has been stretched.”
The company’s 2025 outlook “reflects expected continued periodic supply constraints and related drug shortage notifications across a number of products and geographies.” Novo Nordisk also acknowledged that there will be “capacity limitations at some manufacturing sites” this year.