Sitting on a Throne of Lies

By Scott Brunner, CAE | December 24, 2024 | PLEASE SHARE THIS ARTICLE.

Quoting Buddy the Elf from Will Ferrell’s classic holiday movie is always in season, but never more so than in this particular season, and I don’t mean because the holidays are once again upon us.

I’m talking about GLP-1 season, this strange epoch in which drugmakers have so overhyped and over-advertised their O-o-o-Ozempic and its sister wonder drugs that the FDA-approved injectables have been in shortage now for 30-months (though FDA now says the tirzepatide shortage is resolved) – even as the number of conditions for which the drugs are indicated grows, and with it the demand for them.

During shortages like this one, FDA policy specifically allows licensed pharmacies to prepare compounded versions of the FDA-approved drug — custom-made copies, prepared in sterile labs and based on a prescription from a licensed provider. It’s intentional policy to help ensure that patients can continue to access medications they need, even when the supply chain breaks down.

And so state-licensed compounding pharmacies have been filling prescriptions for compounded semaglutide and tirzepatide, the active pharmaceutical ingredient in the FDA-approved GLP-1 injectables, while the finished-form drugs have been in shortage.

The drugmakers don’t like that, and so they’ve spearheaded a campaign to misrepresent and even restrict state-licensed compounding pharmacies.

But, to quote Buddy, they sit on a throne of lies.

I admit, I’ve never liked that word, “lie.” Even when used properly, it sounds harsh. Anyone can misspeak, but a lie intentionally misleads.

Alas, that’s the only way I know to characterize these drugmakers’ ploys.

Let’s start with the multiple rounds of cease-and-desist letters attorneys for GLP-1 drug manufacturers Novo Nordisk and Eli Lilly sent to compounding pharmacies and to physician clinics demanding they stop dispensing or prescribing compounded GLP-1s. The threatening letter to pharmacies is a maelstrom of factual error, misstating what law and regulation actually say about pharmacies’ ability to prepare copies of in-shortage,FDA-approved drugs.

But it didn’t stop there. In September, news broke that Eli Lilly sent letters to patients it learned had taken compounded versions of GLP-1 drugs, asking for access to their medical records. Drugmakers asking for confidential records is questionable enough. But to do so just to build a case against the very therapies that are demonstrably benefiting those patients? That’s not just creepy, it’s intimidating.?

Their CEO admitted as much, telling Bloomberg, “We’re going after this with our legal tools; we send letters to people and threaten them.”

Let that sink in.

Drugmakers have also fired a fusillade of false claims— making confusing public statements conflating legitimate compounded drugs with counterfeit substances, despite knowing those aren’t comparable. Still, that conflation has been repeated in story after story.

Both companies have claimed they’ve tested compounded GLP-1s and found potency variations and impurities. But did they? When asked by The Washington Post how a big corporation was able to obtain samples of prescription-only drugs, Lilly declined to comment. Nor would it say whether those drugs really came from state-licensed pharmacies, whether they had been stored properly, how old they were when tested, or whether the seal was intact when they tested the drug. Those salient details are germane to the potency of the drugs. But sharing them would undercut the drugmakers’ headline-grabbing claims, so of course they’ve declined to do so.?

Drugmakers have run digital ads noting adverse events with compounded GLP-1s. Conveniently, they fail to note the exponentially higher number of remarkably similar adverse events with the FDA-approved versions.

Prior to the FDA’s resolution of the tirzepatide injection shortage, we saw misleading ballyhooing by Lilly’s CEO that its Zepbound was once again “available,” suggesting the shortage was over well before FDA determined it so. And even now, with the tirzepatide shortage supposedly “resolved” — for the moment, at least — many pharmacies cannot access the FDA-approved version of the drug needed to transition hundreds of thousands of patients who have been taking the compounded version.

On August 28 Lilly wrote to FDA urging that tirzepatide be added to the “Demonstrably Difficult to Compound” List, placing it off limits for compounding. Novo followed in October with a similar request that semaglutide be restricted. There’s no indication of why it took the drugmakers a good two years to assert that the compounding of tirzepatide and semaglutide API was so difficult that FDA should, via emergency action, ban the compounding of it. In fact, the manufacturing of the GLP-1molecules may well be quite complex, but compounding with them is simply not.

A throne of lies.

So what is true?

In our healthcare system, FDA-approved drugs are first-line therapies, and that includes GLP-1s. They are manufactured to the highest standard, have been judged safe and effective, and — assuming they’re appropriate for and accessible to a patient — are always what should be prescribed.

But Novo’s and Lilly’s FDA-approved GLP-1s have long been in shortage. That’s why physicians are prescribing and pharmacies are preparing compounded copies of those drugs, as FDA policy allows.

Compounded drugs are not FDA-approved, but drugmakers make an illogical leap in asserting they are inherently unsafe. In fact, state-licensed compounding pharmacies operate in a rigorous safety compliance framework, adhering to federal and state law and extensive U.S. Pharmacopeia compounding standards. Labs are regularly inspected by state boards of pharmacy. The active ingredients used come from FDA-registered manufacturers, and the potency and purity of the API are backed up by certificates of analysis and often by third-party testing. ?

Undoubtedly, GLP-1s are wonder drugs. But their shortage is, in part, the drugmakers' own making. And even now, with pharmacies unable to access the FDA-approved GLP-1 injectables – including finished-form tirzepatide products – in quantities needed to serve their patients, drugmakers have recommenced their television advertising.

Buddy the Elf might say that’s just one more lie on the throne of lies – because the drugs they are advertising are not yet available in quantities to meet demand. Until they are, state-licensed pharmacies will continue to prepare compounded copies, operating within FDA guidance to provide patients access to life-changing medications during this period when the drugmakers cannot.

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Scott Brunner, CAE, is chief executive officer at the Alliance for Pharmacy Compounding APC is?the compounding industry trade association and the voice for pharmacy compounding, representing more than 600 compounding small businesses – including compounding pharmacists and technicians in both 503A and 503B settings, as well as prescribers, educators, researchers, and suppliers. Learn more, at compounding.com or a4pc.org.