State update: Colorado ignores drug makers’ ploy

Last week, the Colorado State Board of Pharmacy considered a request from Eli Lilly and Novo Nordisk for the board to send a boilerplate “fill-in-the-blank” letter to the FDA. The letter would have urged the agency to classify semaglutide as demonstrably difficult to compound — despite the fact that the FDA has not yet finalized the relevant rule or even established definitive criteria for how it will make such determinations.

Fortunately, after emerging from executive session, the board opted to ignore the companies’ request and take no action on GLP-1 medications.

That said, what the drugmakers tried to pull in Colorado is indicative of their latest strategy: Twist (or ignore) the truth and try to convince state pharmacy boards that compounded GLP-1 drugs are unsafe for patients so those boards will share these false concerns with the FDA. In this case, Lilly and Novo claim that pharmacists create APIs (they don’t), and that those APIs are too complex for compounders to create. 

If that doesn’t work, they try a different tack: claiming (again, falsely) that the APIs compounders use are somehow less safe than the ones used in Big Pharma factories. Thankfully the Colorado board saw through the nonsense, but we all need to be vigilant, as we’re certain to see these tactics repeated. Stay tuned for details of our plans for confronting it.