Because Ned Said: FDA Is Sued Over Removal of Blockbuster Weight Loss Drug From Shortages List

Ned Milenkovich, PharmD, JD;

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January 1, 2025

Pharmacy Times

December 2024

Volume90

Issue 12

Because Ned Said: FDA Is Sued Over Removal of Blockbuster Weight Loss Drug From Shortages List

Author(s):

Ned Milenkovich, PharmD, JD

Key Takeaways

The FDA's removal of tirzepatide from the drug shortage list led to a lawsuit, claiming ongoing scarcity and patient access issues.
The FDA agreed to reevaluate its decision, pausing litigation and allowing compounding pharmacies to continue producing tirzepatide.
Eli Lilly asserts that their approved products are available and warns against risks from unapproved versions.
The FDA's enforcement discretion will extend until two weeks after its decision reconsideration, with potential legal challenges if availability issues persist.

Some outsourcers and pharmacies have capitalized on the shortages, producing compounded versions.

Well, well, well. Look what the cat just dragged in. You guessed it: another hot new pharmacy issue. This time, the issue revolves around manufactured drugs for the treatment of diabetes but that also have the ability to provide dramatic weight loss. When the otherwise commercially available drugs were put on the FDA drug shortage list, pharmacy compounders and outsourcers began to prepare their own versions of the drug and made them available in the marketplace. This is allowed so long as the drugs in question—tirzepatide (Mounjaro, Zepbound; Eli Lilly) and semaglutide (Ozempic, Wegovy; Novo Nordisk)—remain in the drug shortage category and therefore not commercially available.

Image credit: Choi_ Nikolai | stock.adobe.com

However, the FDA upset the industry applecart when it recently announced that it was removing tirzepatide from the drug shortage list. Almost immediately, a lawsuit was filed protesting this decision. The Outsourcing Facilities Association claimed that there was still a shortage of tirzepatide in the marketplace and that patients were unable to readily obtain it. The plaintiff association added that the FDA was acting in a “reckless and arbitrary” manner and asked a Texas federal court to place a restraining order on the FDA.¹The FDA backpedaled quickly, cried uncle, and said it would reconsider its decision to remove the drug from its official drug shortage list.

About the Author

Ned Milenkovich, PharmD, JD, is chair of the health care law practice at Much Shelist PC and is the former vice chairman of the Illinois State Board of Pharmacy. He can be reached at 312-521- 2482 or nmilenkovich@muchlaw.com.

Now, the litigation is stayed pending an unopposed FDA motion to remand the situation for further internal examination as to whether there is still a shortage of the drug. In the motion, the FDA asked the court to pause the lawsuit and remand the case back to the FDA, which would allow it to “reevaluate the decision in light of plaintiffs’ challenges to it.” US District Judge Mark Pittman granted the motion and put the lawsuit on hold. This allowed compounding pharmacies and outsourcers to continue making and selling their own versions of the drug for patients who were experiencing delays receiving their fulfilled prescription.²

Meanwhile, the FDA said it would not pursue any regulatory enforcement action against compounding pharmacies and outsourcers for making copies of the drugs while it reconsiders its own decision.²This is an important development for compounding pharmacies and outsourcers because removing the drug from the FDA’s drug shortage list means they would no longer be legally allowed to continue making and dispensing their own versions except under certain circumstances set forth in statutes and regulations.

Eli Lilly has maintained that the products are available in the marketplace and that in its view, compounded pharmacy variations of tirzepatide present risks for patients.

“All doses of Lilly’s FDA-approved medicines are available, and it is important that patients not be exposed to the risks in taking untested, unapproved knockoffs,” stated one representative.¹

The FDA said its enforcement discretion will extend from the date of the order to 2 weeks beyond its reconsideration of the decision. One thing is clear: If the FDA once again removes the drug from the shortage list and it is not, in fact, available, it will find itself right back in court defending its decision. And with a new Donald Trump administration champing at the bit to reform government agencies such as the FDA, it should be mindful about getting to the correct answer without drawing public ire and attention.