Sorry, compounded drugs are NOT “unapproved”

Talk about slick moves. Drugmakers and their spokesminions have done a masterful job in recent months replacing the words “compounded drugs” in their public pronouncements with a more menacing elocution: “unapproved drugs.” And unfortunately, reporters, think-tankers, talking heads, and even FDA’s communications team have bought in. It’s the new vernacular.

Never mind that “unapproved drugs” is not syntax you’ll find anywhere in the Food, Drug & Cosmetic Act or FDA’s “Essentially a Copy” Guidance.

And that’s what makes its insertion into the debate about compounded GLP1s so deliciously perfect: It sounds right, and it stigmatizes compounded drugs, makes them seem illicit and sketchy. Score a point for disingenuous drugmakers.

But it’s not factually accurate or logically compelling (facts and logic being beside the point in drugmaker proclamations about compounded drugs).

Yes, compounded drugs are “not FDA-approved” – that’s the language of the FD&C Act and FDA guidance – but the opposite of FDA approval is not “unapproved.” FDA-approved is a designation – an important one. But to suggest that every drug that hasn’t earned that rigorous designation is “unapproved” is not accurate. The opposite of FDA-approved is “not FDA-approved,*” which is the precise wording of statute and guidance.  

To assert that compounded drugs are “unapproved” is to act as if compounded drugs are not authorized in the FD&C Act and the laws of all 50 states (which do seem to approve of compounded drugs as necessary therapies).

To assert that compounded drugs are “unapproved” is to disregard criteria in the FD&C Act and FDA guidance for what can be compounded and in what circumstances.

To assert that compounded drugs are “unapproved” is to pretend that FD&C Act and FDA itself has not indicated that certain ingredients have been evaluated for use in compounded medications that are themselves not “FDA-approved.”

Which is why, as slick as drugmakers’ sly injection of “unapproved drugs” into the GLP1 debate is, it also requires a certain willful ignorance.

And so:

If you are a journalist using the expression “unapproved drugs” in your reporting, you are not merely misleading readers with incorrect terminology. You are not reporting objectively. “Unapproved drugs” automatically drapes discussion of compounded drugs in suspicion in a way that law and regulation do not.

If you are an FDA communicator or other staffer using the words “unapproved drugs” in public statements, alerts or warnings, you are out over your statutory skis, applying stigma to a practice authorized in the same statute that authorizes your employer.

And if you are researcher, physician, or other opinion leader using those words, well, you should know better. (My real fear is that some do know better and don’t care.)

Admittedly “unapproved drugs” is a catchy little bit of syntactic spin, hard to avoid. A few weeks ago I was part of an American Enterprise Institute panel discussion that included “unapproved drugs” in its title – a point I took exception to in my comments. But then onstage only a few sentences later, those words were coming out of my mouth like I was a drugmaker sock puppet. I could kick myself. (At least I did point out how the folks spouting “unapproved drugs” don’t seem to apply the term to therapies that don’t threaten market share.)

Here's the rub: Precision matters in public discourse, and words wield power. When drugmakers blur the lines between “not FDA-approved” and “unapproved,” they do a disservice to both patients and professionals. It’s a trick that sounds official but is, in truth, a sleight of hand designed to deceive, divide, and deflect.

Compounded drugs are not FDA-approved – but they’re also perfectly legal and necessary in our healthcare system. The stakes are too high to let drugmakers’ new terminology slip by without challenge. After all, when we lose the fight for words, we lose the fight for truth.

Scott Brunner, CAE, is CEO of the Alliance for Pharmacy Compounding.

* Opposites aren’t always intuitive, mind you. Years ago, I heard a minister state in a sermon that the opposite of love is not hate, it’s apathy. It stuck with me.