Novo Nordisk requests FDA ban on compounded semaglutide

Novo Nordisk has submitted a citizen petition to the FDA, advocating for the exclusion of semaglutide from the 503B Bulks List. This list permits outsourcing facilities to compound certain bulk drug substances. Novo Nordisk's petition contends that there is no clinical necessity for semaglutide to be compounded because FDA-approved alternatives like Rybelsus, Ozempic, and Wegovy sufficiently address patient needs for diabetes and weight management treatments.

The petition also requests that the FDA revoke the Interim Policy on Compounding Using Bulk Drug Substances under Section 503B. Novo Nordisk argues that this policy encourages the production of compounded semaglutide without the comprehensive testing mandated for FDA-approved medications. The company expressed concerns regarding safety, highlighting reports of adverse events linked to compounded semaglutide, such as dosing inaccuracies and impurities found in these compounded formulations.

Novo Nordisk further asserts that compounded semaglutide presents significant risks, including potential immunogenicity and reduced efficacy due to inconsistent dosing. The company insists that retaining semaglutide on the 503B Bulks List could compromise the FDA-approved drug development process's integrity. This could dissuade pharmaceutical companies from investing in the necessary research and development to introduce new treatments to the market.

The FDA is now required to respond to this petition within 180 days.

This situation forms part of the broader legal disputes surrounding the sale of non-FDA approved drug modifications. Recently, Novo Nordisk has initiated legal actions against compounding pharmacies for selling altered versions of semaglutide. In a related case, a U.S. District Judge in Florida dismissed a lawsuit brought by Eli Lilly against the compounding pharmacy RXCompoundStore.com. The dismissal was with prejudice, preventing Eli Lilly from refiling the claim.

Eli Lilly had accused the pharmacy of breaching Florida’s Drug and Cosmetic Act and the Florida Deceptive and Unfair Trade Practices Act by distributing compounded versions of tirzepatide, which is used in Lilly’s FDA-approved treatments for diabetes and weight management. The company argued that these compounded drugs, being non-FDA approved, posed safety hazards. However, Judge Altman ruled that Eli Lilly's attempt to enforce federal regulations through state laws was misplaced, as such enforcement is the FDA's responsibility and not that of private companies.