With the advent of GLP-1s — and more specifically compounded GLP-1s — the media has been looking to APC for information and perspective. It’s an ongoing opportunity to educate reporters and the public about compounding, and we’ve seized it.
On the upside, we’ve positioned APC as a credible source of info about pharmacy compounding. Reporters now know us as the national trade association for the compounding industry, and they are reaching out. Daily. Relentlessly. I now spend a good third of any workday dispelling myths, poking holes in drugmaker misrepresentations, and enunciating what law and regulation actually say about compounding. Ditto for APC advocacy chief Tenille Davis.
The result — without a doubt — is news stories that are more balanced and accurate and in which APC’s perspective is included, often prominently. (You can see some samples of this at a4pc.org/inthenews).
This week has been such a week. We’ve briefed reporters from NPR, Reuters, and Politico. We also briefed ABC News producers for an interview next week with APC Board Chair Joe Navarra and me. We’ve also issued some statements — think of them as shouting as opposed to whispering. Below are excerpts of those, so you’ll know what we’re saying.
ABOUT NOVO’S CEO’S COMMENTS ON COMPOUNDED GLP-1 ADVERSE EVENTS
Any serious adverse event, whether from a compounded or FDA-approved drug, is deeply concerning. But context matters, and there’s plenty Mr. Jorgensen left unsaid in his comments this week to CNN — including not mentioning his own FDA-approved drug products’ adverse events records. Moreover, he’s used FDA’s FAERS dashboard to pluck the alarming number of deaths he says have resulted from compounded semaglutide. But the FAERS database itself specifically reminds that a report in the database does not mean that the drug caused the adverse event.
Moreover, as compounded drugs go, there’s often no indication in the FAERS database who prepared the substance in question — was it a legitimate state-licensed compounding pharmacy or a bogus entity claiming to be a pharmacy? That distinction matters, especially if the aim is to prevent more such adverse events. But if the aim is to spin a headline-grabbing narrative that casts pharmacy compounding in a bad light, maybe not.
ABOUT APC’S RESPONSE TO LILLY’S REQUEST TO ADD TIRZEPATIDE TO THE DDC LIST
On August 28, Eli Lilly submitted a comment letter to FDA urging the agency to take emergency action to add tirzepatide to the “Demonstrably Difficult to Compound” list, thereby permanently prohibiting compounding with it.
This week APC responded with a comment letter of our own asking the agency to deny Lilly’s request. Our letter pokes holes in Lilly’s ask — including pointing out that it sure seemed to take the drugmaker a long time to muster enough concern about patients’ safety to write such a letter. It’s enough to make one question the drugmaker’s motive, isn’t it?
(You can read about our letter below.)
ABOUT FDA’S WARNING ABOUT PRODUCTS FROM FULLERTON WELLNESS
It’s not even a pharmacy, folks, much less a compounding pharmacy.
Notice that FDA’s warning last week scrupulously avoids calling it a pharmacy, even though it refers to the non-compliant sterile drugs they were preparing as “compounded drugs.”
For further proof that this is not a pharmacy, try looking it up on the California Board of Pharmacy website. You won’t find Fullerton Wellness to be licensed in California.
So what gives? Well, it may be a med spa that does ‘physician compounding’ — meaning compounding is overseen by a physician, not a pharmacist. It’s a practice authorized in the laws of all 50 states but is not nearly as well regulated as traditional, USP-compliant pharmacy compounding. Or maybe Fullerton Wellness is a bogus pop-up and therefore a criminal enterprise?
I don’t know. But it’s not a compounding pharmacy. So please don’t refer to it as one.
…
Sometimes we whisper. Sometimes we shout. Either way, we’re telling your story — and looking out for millions of patients who, without compounding, might have nowhere else to turn.
—Scott
Scott Brunner, CAE, is the CEO of the Alliance for Pharmacy Compounding. You can reach him at scott@a4pc.org.
