FDA’s confusing warning letters

You might have heard about the sudden push by the administration to end misleading drug ads. FDA didn’t even seem to wait for the ink to dry on the executive order before beginning a crackdown: It sent hundreds of letters to drugmakers and other companies accusing them of misleading patients in their advertising.

While we might enjoy a moment of schadenfreude knowing that both Eli Lilly and Novo Nordisk were on the receiving end of these letters, we’re much more concerned about the accusations leveled at some compounders. (And we mean legitimate, licensed compounders — honestly, we’re happy to see those illegal pop-up “clinics” get what’s coming to them.)

The warning letters FDA sent some compounding pharmacies took issue with a perfectly legitimate and accurate claim: that the active ingredient in a compounded GLP-1 is the same as that in the FDA-approved drug.

FDA claims such statements are deceptive and misleading.

FDA is, frankly, contradicting itself.

It’s not a matter of opinion: The API must be the same as in a commercial drug or it wouldn’t be eligible for compounding. And FDA has made it crystal clear — again and again over the past three years — that yes, semaglutide and tirzepatide are very much eligible for compounding (in those circumstances we know so well).

Sure, drugmakers have been claiming that their API is magically superior to what compounders use, but no one is buying that, including the FDA – hence the new green list of approved manufacturers. And while APC’s Shortage Drug Compounding Best Practices document advises against making such statements in marketing, that’s strictly to avoid a trademark lawsuit. 

All of which leads us to ask what the blazes is wrong with saying — quite accurately — that the semaglutide or tirzepatide in a compounded formulation is the same active ingredient as in the mass-produced FDA-approved drug? 

The answer is: Nothing. But it’s frustrating that someone might need to remind FDA about that.