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As the landscape of diabetes and obesity treatment continues to evolve, it's becoming clear that the legal side of things is just as complex as the medical. On August 9, 2024, Eli Lilly and Company fired off a cease-and-desist letter through Kirkland & Ellis LLP, aiming straight at those involved in compounding tirzepatide products. If you’re in the compounding pharmacy business or a patient relying on compounded meds, this is something you need to pay attention to.
What’s Going On with Section 503A of the FDCA?
For those not steeped in pharmacy regulations, Section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA) might not be bedtime reading, but it's crucial to understand. This section is all about keeping pharmacies in check, especially when it comes to creating copies of patented FDA-approved drugs. The law says that if a drug is “essentially a copy” of something already available on the market, you can’t just whip up a batch and sell it—unless it’s on the FDA’s shortage list.
Now, here’s where it gets tricky. Eli Lilly’s popular tirzepatide-based drugs—Mounjaro® and Zepbound®—are still on the FDA’s master drug shortage list. But, according to the FDA, all doses are listed as “available.” That means, legally speaking, these products are considered accessible, leaving compounded and Eli Lilly’s legal enforcement team in somewhat of a legal grey area. Is it in shortage or not?
It’s important to note that Eli Lilly's claims about the availability of their medication to the FDA have faced social media backlash from users who still report widespread shortages. During a recent earnings call, Lilly clarified that the availability reported to the FDA reflects wholesalers' ability to place and receive orders from Lilly promptly. However, this does not necessarily mean the medication will be readily available at your local pharmacy.
Patented Medications and FDA Shortages: The Grey Area
One of the most complex parts of this issue is how patented medications are treated during FDA shortages. Typically, you can’t just start compounding a patented drug without permission. However, there’s an exemption when that drug is on the FDA’s shortage list. But as this case shows, even that exemption isn’t straightforward. Eli Lilly’s letter makes their position clear: when their patented drug is commercially available in all doses, they’re going to take legal action against copycat versions.
This raises many questions about how compounding pharmacies can operate during drug shortages. If drugs that are technically on the shortage list are still deemed “available,” where does that leave patients who rely on compounded medications? It’s a legal and ethical grey area that compounding pharmacies will need to navigate carefully.
The Legal Hammer: Stop Compounding Tirzepatide
In plain language, Eli Lilly is making their position crystal clear, "The shortage is over." They’re not just suggesting the recipients of these letters stop compounding Tirzepatide; they’re demanding it. The letter insists that all promotion, sale, and compounding of tirzepatide must cease immediately. Eli Lilly wants confirmation in writing by August 16, 2024, that recipients have stopped any and all such activities.
This isn’t as much about protecting their bottom line—although let’s be real, that’s part of it. Lilly and Novo have both independently reported that they sell every single pen that they can manufacture. Moreso, it is about maintaining control over how their patented medications are distributed and ensuring that only their approved products are available on the market. It’s also about brand protection. With media abuzz with recent reports of an increase in GLP-1 overdose calls, the general public is ripe for a lawfare blitz against the legality of compounded medications being mass-marketed and sold to consumers.
What This Means for the Compounding Market
If you’re running a 503A pharmacy, this letter is a definitely alarming. No one wants to be in the crosshairs of the legal department of a pharmaceutical company that is essentially printing money with a generational drug. Under Normal circumstances, 503A pharmacies are legally able to compound medications based on medically necessary individual prescriptions, but there are strict limitations involved. You can’t legally produce a medication that’s basically a knock-off of a commercially available drug unless it’s on the FDA shortage list and truly unavailable. The FDA’s “available” status for Mounjaro® and Zepbound® complicates things, making any attempt to compound tirzepatide legally risky.
For 503B pharmacies, which operate on a larger scale, the situation is just as precarious. These facilities can compound medications without individual prescriptions and distribute them across state lines, but they must adhere strictly to FDA regulations. The fact that tirzepatide is on the FDA’s shortage list but still marked as “available” means that 503B pharmacies could also face significant legal risks if they attempt to compound the drug.
The Bottom Line: Stay Compliant, Stay Informed
Eli Lilly’s cease-and-desist letter isn’t just a legal threat; it’s a clear indication of how high the stakes are in the world of drug compounding. If you’re in the compounding business, it’s more important than ever to stay informed about FDA regulations and to ensure that your practices are fully compliant with the law. The consequences of getting it wrong could be severe—not just for your business, but for the patients who rely on your services.
As this situation unfolds, it’s likely that more legal challenges will arise, especially as the demand for branded and compounded medications continues to grow. For now, the message is clear: if you’re compounding tirzepatide, it’s game on with Eli Lilly’s legal department.
Stay tuned to OnThePen.com for more updates and in-depth analysis on the latest developments in weight loss and diabetes treatments. Sharing this article is a powerful form of advocacy that brings us closer to our goal of educating the masses and reducing the stigma of obesity. If you found this article insightful, please share it within your networks, especially in Facebook groups and Reddit forums dedicated to GLP-1 medications and diabetes management. Together, we can make a difference.
Editing Note:
It is unclear what entities and how many have received this or similar letters. Some reports suggest that these letters have been targeted primarily at medspas and healthcare providers, rather than pharmacies, at this point. If true, this distinction could indicate a strategic focus by Eli Lilly on curbing the promotion and use of compounded tirzepatide in non-pharmacy settings, where regulatory oversight may differ. The absence of reported actions against pharmacies might suggest a different approach or timeline for addressing compounding practices within traditional pharmacy operations.
If you or anyone you know has received similar legal notifications from Eli Lilly, feel free to forward a copy to hello@onthepen.com and we may use it in future communications through the website or social media.
As this situation develops, it’s crucial for all parties involved—medspas, healthcare providers, and pharmacies alike—to stay informed and prepared for potential legal implications. Transparency from Eli Lilly regarding their enforcement strategy would also help clarify the landscape for everyone affected.
Editing Update 10:35 p.m. 8/12/24:
We can confirm three separate entities receiving the similarly worded cease and desist letter from Kirkland & Ellis LLP. One medspa, one provider, and one telehealth company. See below:
Editing Update 9:12p.m. 8/13/24:
Eventually the compounding pharmacies will have to stop producing patented drugs. However, Eli Lilly is unlikely to go to court to seek to stop the compounding pharmacies based upon the legal theory advanced in the article, that the shortage is over until the FDA has removed the drug from its master list. Making such a claim now would inevitably result in the compounding pharmacies producing abundant evidence of the contrary. The compounding pharmacies would call the FDA officials in charge of managing the master shortage list to explain why there is still a shortage. Then they'd call both pharmacists and consumer to produce evidence. Lilly could not convince a judge of the drugs availability. Eli Lilly will be unwill…
The only reason that I use compounded is that it is much easier to access and it is more affordable. If Eli Lilly really doesn’t care about their bottom line being affected then they will offer their branded medication at the same prices as compounded pharmacies. I want to use the real thing badly but unfortunately I and many others like me can’t afford to sit at the Eli Lilly table. Even with a coupon.