On October 22, Novo Nordisk (Novo) nominated semaglutide products, which include its popular drugs marketed as Ozempic for type 2 diabetes and Wegovy for chronic weight management, for inclusion on FDA's Demonstrable Difficulties for Compounding (DDC) lists pursuant to Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). These lists do not currently exist, but FDA, under statutory mandate, proposed to create them in a Proposed Rule discussed below. Should Novo's submission be successful, a licensed pharmacist in a state licensed pharmacy or a federal facility, a licensed physician, or a facility registered as an outsourcing facility would not qualify for certain exemptions from the FD&C Act's new drug approval process, and therefore semaglutide may not be compounded under either Section 503A or Section 503B. A successful submission would mean that semaglutide products are deemed too complex or difficult to compound and could pose safety risks to patients if manufactured incorrectly.
Why Novo Nordisk Nominated Semaglutide
Novo's nomination of semaglutide products to the DDC lists makes several arguments, including that semaglutide products are complex peptide-based drugs that require stringent manufacturing conditions to ensure consistent potency and stability. Novo also argues that compounded versions of semaglutide have "different impurity profiles and different physical and chemical stabilities" compared with FDA-approved versions, which Novo contends could compromise patient safety. Furthermore, Novo's nomination states that 388 serious adverse events have been associated with "compounded semaglutide" since 2018, according to FDA's data. Of these, 10 involved deaths, per the submission. Novo's submission asserts that only FDA-approved formulations can guarantee the quality and effectiveness on which patients rely.
What is Ahead
In addition to the submission, Novo recently challenged compounders by filing several lawsuits against wellness clinics and medical spas marketing compounded semaglutide in June 2023, for which Novo secured a permanent injunction in February 2024.
A month later, after years of deliberation, FDA issued the Proposed Rule proposing to establish criteria it will use in evaluating whether drug products or categories of drug products belong on a DDC list. FDA proposes to consider these criteria individually and collectively, and to consider the risks and benefits to patients.
We anticipate that FDA will not respond to Novo's requests until the Proposed Rule is finalized, which most likely will not occur until the new administration settles in.
* The authors thank Law Clerk Eden Caliendo for her assistance writing this article.
