Novo Nordisk has filed an amicus brief in support of competitor Eli Lilly in the ongoing lawsuit between the Outsourcing Facilities Association and the FDA. The company is siding with the FDA and Eli Lilly in their effort to shut down compounded versions of tirzepatide, arguing that the products are unsafe, unregulated and unnecessary now that the commercial supply has stabilized. The filing adds another layer to an already heated legal battle over access, regulation and the definition of a true drug shortage.
Novo’s argument is built on the idea that compounded GLP1 drugs are a danger to patients. The company warns that compounders do not follow the same manufacturing standards as commercial drugmakers, leading to products that may be inconsistent in potency or contaminated with harmful substances. Their brief highlights past incidents in which compounded drugs caused public health crises and emphasizes that compounded semaglutide formulations are particularly risky because they do not use the same recombinant DNA technology as the FDA approved versions.
Novo also takes direct aim at the compounding industry’s claims that shortages justify continued production. The company argues that while individual pharmacies may experience temporary supply issues, this does not constitute a national shortage that would legally permit large scale compounding. They accuse the compounding industry of using anecdotal patient reports and unreliable data to push a misleading narrative that the commercial supply cannot meet demand.
The company further claims that compounders have misrepresented the FDA’s stance on enforcement discretion. Novo says compounders have framed the agency’s inaction as an endorsement of compounded GLP-1 safety when in reality the FDA has repeatedly warned about the risks of these medications.
The brief calls the marketing of compounded semaglutide and tirzepatide the largest uncontrolled and unconsented human experiment of our time.
Novo is urging the court to deny the OFA’s request for a preliminary injunction that would allow compounding to continue while the case plays out. They argue that granting the injunction would undermine the FDA’s authority and keep (what they deem) unsafe products on the market. The judge in the case could rule on the preliminary injunction as early as February 25, which means compounded tirzepatide may soon face a major legal barrier if the ruling favors the FDA.
For Novo's part, they are gearing up for a potential fight of their own as the FDA's decision to remove semaglutide from the master shortage list looms ominously on the horizon. This impending decision has significant implications not only for Novo Nordisk but also for patients who rely on these medications for managing chronic conditions such as obesity and type 2 diabetes. For several months now, Novo has been actively communicating with the FDA, providing detailed reports that assert all doses of their branded semaglutide products namely, Wegovy and Ozempic, are commercially available and adequately supplied to meet market demand.
The timeline of this case (as it relates to the continued availability of compounded tirzepatide) has been somewhat unpredictable from the start, with shifting enforcement discretion from the FDA and unexpected turns in how the agency has communicated its intentions to industry groups. At one point, it seemed as though the FDA had quietly signaled to the Alliance for Pharmacy Compounding that they would not take enforcement action during the trial, but later clarifications revealed a much stricter timeline that is tied to the court’s decisions. That means February 25 is not just another procedural moment. It could be the point where compounding is either temporarily protected or effectively banned outside of the handful of 503a regulatory loopholes (custom dosing and custom formulations) some pharmacies have signaled they will continue to mass-produce.
With this filing, Novo has aligned itself with Eli Lilly and the FDA in what has become a direct challenge to the compounding industry’s role in the obesity and diabetes market. The court’s ruling will decide whether compounded tirzepatide remains available, but the larger fight over regulatory control and patient access is far from over. Novo’s involvement signals that drug manufacturers see this case as a key battleground in maintaining their hold on the obesity market, and whatever happens on February 25 will be just the beginning.
I am involved in a GLP-1 project that, starting 3-1-25, will potentially serve 3 million covered lives in the self-insured business-to-business market. We have been in constant contact with these employers, and they are desperate for a cost-effective GLP-1 solution. Big Pharma can flex all it wants, but these companies, and many of them are not insubstantial size-wise, are just flat out not going to offer this as any sort of covered benefit or even work with us on a employee-sponsored self-pay benefit under a branded product.
To me, Big Pharma is handling this in an immoral fashion. If they would just price this in a reasonable fashion a lot of this back and forth would go away. There ar…