As a federal court in Texas hears a case pitting the FDA versus compounders who want to continue to manufacture cheaper knockoff versions of popular weight loss drugs, Novo Nordisk will not have to sit idly by.
After initially rejecting Novo’s bid to weigh in on the case, U.S. District court Judge Mark Pittman has sided with the Danish company, which produces mega-blockbuster semaglutide treatments Ozempic and Wegovy for diabetes and weight loss, respectively.
Pittman has accepted Novo’s renewed motion to back up its claim in court that the company can meet the heavy demand for its semaglutide products.
When there is a shortage of a branded medication, the FDA permits compounding pharmacies to produce copycat versions. In most situations, the manufacturing of these treatments is done piecemeal. But with the skyrocketing demand for weight loss drugs, it has become big business for compounders who have been supplying healthcare spas and telehealth providers, such as Hims & Hers, since Novo and fellow obesity and diabetes drugmaker Eli Lilly declared their drugs were in shortage in 2022.
In making his ruling, Pittman wrote that "good cause exists for Novo Nordisk's intervention in this case under Federal Rule of Civil Procedure 24." The rule allows for intervention of a third party when its interests could be harmed by a case's outcome.
Novo's motion to be included in the case was "unopposed," by both the FDA and the Outsourcing Facilities Association (OFA), which filed the original complaint.
In requesting inclusion into the case, Novo cited "well-recognized safety and efficacy risks" associated with compounded semaglutide. The company also maintained that the continued sale of "riskier, non-approved compounded products undermine the investments" Novo has undertaken in developing the groundbreaking drugs.
In October of last year, when Lilly said that the shortage of its drugs was over, the OFA and Texas-based FarmaKeio Superior Custom Compounding quickly filed a lawsuit against the FDA, saying that its decision to remove the drugs from its shortage list was “reckless and arbitrary” and “lacking any semblance of lawful process.” The lawsuit also claimed that Lilly “is self-interested in monopolizing the market.”
Last month, when the FDA removed Novo’s drugs from the shortage list and gave compounders a grace period of 60 to 90 days to halt production of semaglutide, the OFA and FarmaKeio filed another lawsuit against the U.S. regulator. The complaint alleged that the FDA is “dismissing evidence that the shortage persists.”
The lawsuit filed in October against the FDA is still ongoing, and, in January, Lilly filed a motion to intervene.