The gauntlet has been laid down and now it’s also been run through the FDA and courts will tell the tale. With Novo Nordisk’s (Novo) suit against Him and Hers, the issue of 503B outsourcing facilities compounding of copies of FDA-approved products may hang in the balance. FDA has apparently taken a hard line on the issue of compounding duplicate versions of FDA approved drugs and that position appears to have been even more hardened by Him and Hers decision to introduce a compounded, unapproved version, of Novo’s newly approved oral Wegovy tablet product.
FDA Commissioner Marty Makary, M.D. was reported by Fraiser Kansteiner in Fierce Pharma here to have said “FDA will take swift action against companies mass-marketing illegal copycat drugs, claiming they are similar to FDA-approved products,” FDA commissioner Marty Makary, M.D., said in a Feb. 5 post on X. “The FDA cannot verify the quality, safety, or effectiveness of non-approved drugs.” This statement was issued the day on which Him and Hers launched an unapproved version of the Wegovy oral product. Kansteiner’s article went on to report, “The action by Hims & Hers is illegal mass compounding that poses a significant risk to patient safety,” the Danish drugmaker continued, pledging to take legal and regulatory action in response.”
The issue of compounding copycat versions of marketed drug products is certainly not new particularly with the GLP-1 drugs that were previously in shortage. FDA allows for compounded versions of approved drug products to be marketed when the FDA declares there is a shortage in the marketplace of an approved drug product. However, when companies with approved products are able to ramp up production to meet demand, compounded versions may be then subject to enforcement actions. In this instance, since the compounded version was launched the same day as the innovator product, there was clearly no shortage, and compounded versions of the product became almost immediately available and advertised. This seems to be more than the FDA can swallow, hence Dr. Makary’s comments regarding potential enforcement action.
Even today, 503B outsourcing facilities are providing unapproved compounded versions of parenteral GLP-1 product despite the FDA’s protestations. Compounders claim that they are making versions of the approved product with changes due to individual patient needs. However, there is disagreement by brand name manufacturers that these unapproved compounded products do not violate companies’ patents or do not meet the regulatory requirements for mass compounding. It is likely that we will see the litigation target both the newly approved tablet version as well as older parenteral version of GLP-1.
The outcome of the litigation and just exactly what types of enforcement actions that FDA decides to take will undoubtedly have an impact on outsourcing facilities that decide to compound versions of FDA approved drug products and where the lines will ultimately be drawn. It is noted that Dickenson’s FDA Webview reported (here, subscription required) that “Him and Hers has abruptly shelved its GLP‑1 weight-loss pill offering and now faces a patent battle with Novo Nordisk, marking a dramatic escalation in the fight over compounded weight‑loss medications.”
FDA’s wading into the compounding battle as it did in this instance, as well as the result of Novo’s litigation will likely further establish the guardrails on 503B outsourcing facility compounding activities. The root question to ask is how will the outcome of the litigation and FDA enforcement stance impact 503B compounding in general, outside of the GLP-1 products space. Stay tuned!
