October 25, 2024

Full of sound and fury, signifying nothing

You might have heard that Novo Nordisk this week asked the FDA to add semaglutide to the Demonstrably Difficult to Compound list. This follows a similar letter to FDA from Eli Lilly in August urging that tirzepatide be added to the DDC list. Of course those drugs are not difficult to compound. Still, it made headlines, and of course APC was (and will remain) in touch with both media and regulators to explain just how self-serving those drugmaker requests are.

To be clear: Novo’s request doesn’t affect a thing — it’s only a request, and the FDA is not obligated to act.

For details, the Hill has an excellent writeup on Novo’s latest attempt to game restrict patient access to semaglutide.