Compounding pharmacy says Eli Lilly’s cease and desist letter means “nothing”

OrderlyMeds, an online pharmacy that sells compounded versions of Eli Lilly’s blockbuster weight-loss drug Zepbound, said the drugmaker’s cease and desist letter means “nothing.”

The Food and Drug Administration declared in December that tirzepatide, the active ingredient in Zepbound, is no longer in a shortage, meaning pharmacies like OrderlyMeds that were selling knockoff versions of the drug can’t sell exact copies. But OrderlyMeds kept selling compounded tirzepatide.

Lilly told them to ‘please stop doing that or we might sue you,’ otherwise known as a cease and desist letter. OrderlyMeds responded on Friday saying the letter “only reinforces and reinvigorates OrderlyMeds’ mission to provide patients with tailored healthcare solutions, access, and choice.”

“Rest assured that OrderlyMeds will defend itself and our patients against these attacks that aimed solely at driving shareholder value for Big Pharma, not the individualized needs of you, the patient,” the company said in a statement.

Now that tirzepatide is not in a shortage, compounding pharmacies can only sell it if it’s adjusted for a patient’s needs — for instance, to remove a nonactive ingredient a patient is allergic to or to produce a dose that the patent-holding drugmaker doesn’t. OrderlyMeds says that what it sells is “individualized” and “personalized.”

“So, what does this mean for our patients?” it said in its response to Lilly. “Nothing.”

A Lilly spokesperson told Sherwood News that it will “continue to take action to stop these illegal actors and urgently call on regulators and law enforcement to do the same.”

“The FDA and a federal court have both made clear that compounders ‘must cease production’ of compounded tirzepatide knockoffs, and anyone continuing to sell mass compounded tirzepatide, including by referring to it as ‘personalized,’ ‘tailored,’ or something similar, is breaking the law and deceiving patients,” the spokesperson said.

The argument that compounding pharmacies can continue selling “personalized” versions of lucrative weight-loss drugs is one that’s also being made by Hims & Hers, which has a much larger patient base than OrderlyMeds. Hims sells compounded semaglutide, the active ingredient in Novo Nordisk’s Ozempic and Wegovy, not tirzepatide.

The shortage of semaglutide was declared over in February. According to the Alliance for Pharmacy Compounding, an industry trade group, Novo sent cease and desist letters to pharmacies immediately after the end of the shortage was declared, despite the FDA giving them a 60-day off-ramp period.

There appears to be a legal challenge brewing between drugmakers and compounding pharmacies, which may be able to sue for patent infringement. That type of litigation is risky because if a judge were to rule against the drugmakers, it could risk their patent and the billions they make selling those drugs.

The FDA could step in and decide that these pharmacies aren’t compliant and need to stop. The FDA is now run by Marty Makary, who used to work at Sesame, a telehealth company that sold compounded semaglutide. Also, things seem pretty hectic over at the FDA at the moment.