This year kicked off with another development in the ongoing saga with the FDA’s shortage status on tirzepatide. This week, Eli Lilly asked to join the Food and Drug Administration as a defendant in the lawsuit brought on by The Outsourcing Facilities Association (OFA). The OFA sued the FDA when the organization updated the status of tirzepatide on the drug shortage list to “resolved.”
Compounders only have permission to manufacture compounded versions of the GLP-1 when it is in shortage. The update meant that compounders must stop creating unbranded versions of Eli Lilly injections Mounjaro and Zepbound.
In this article, we share a timeline of the tirzepatide shortage and lawsuit from OFA. We break down arguments from the parties involved, the OFA, FDA, and Eli Lilly, and what the outcome of the legal battle means for providers and compounders of tirzepatide.
Want more background? Start with our previous articles:
FDA’s Tirzepatide Shortage and Lawsuit Timeline
December 2022: The FDA placed tirzepatide on its drug shortage list.
October 2, 2024: The FDA updated the status for tirzepatide injections on the shortage list from “Currently in Shortage” to “Resolved.” This change meant that Tirzepatide injections, marketed under the brand names Zepbound and Mounjaro by Eli Lilly, could no longer be compounded by 503A Compounding Pharmacies or 503B Outsourcing Facilities. The FDA issued a statement with guidelines to gradually reduce production of unbranded and replicated compounds over a 60-day period.
October 8, 2024: The trade group Outsourcing Facilities Association, representing 503B compounding pharmacies, filed a lawsuit against the FDA. The complaint stated, “Ignoring evidence that the shortage persists, FDA removed tirzepatide from the shortage list without notice, without soliciting input from affected parties and the public, and without meaningful rationale.” After the OFA filed the lawsuit, the FDA temporarily paused to reconsider the shortage.
December 19, 2024: Following the pause to reconsider the shortage, the FDA announced once again that the tirzepatide injection shortage is resolved. In a declaratory order, the FDA stated that “Lilly’s supply is currently meeting or exceeding demands…Lilly has developed reserves…and will meet or exceed projected demands.” At this time, the lawsuit between the FDA and OFA continued.
January 1, 2025: Eli Lilly filed a motion to intervene to join the FDA as a defendant in the OFA lawsuit to “protect its interest and help bring this suit to a swift end.”
January 14, 2025: Judge Mark T. Pittman, the United States District Judge for the Northern District of Texas Fort Worth Division, ordered an expedited hearing of the matter to take place January 14, 2025. During this hearing, the Court will discuss 1) the briefing schedule, and 2) notably, the Court’s desire to convert the OFA’s motion for preliminary injunction to a motion for summary judgment to decide “as a matter of law, whether the agency action is... consistent with the APA.”
The Battle Over the Shortage Status
As the legal war wages on, it’s important to understand the arguments of each of the parties involved. What’s at stake for OFA? What moved Eli Lilly to join? Below, we outline the heart of the argument for each entity.
Outsourcing Facilities Association (OFA):
The OFA believes the FDA’s resolution of the tirzepatide shortage was “reckless and arbitrary.” They accuse the FDA of ignoring evidence that the shortage persists and resolving it with only a post to its website, “depriving patients of much needed treatment and artificially raising drug prices.”
The complaint continues that the way the FDA proceeded was in violation of the Administrative Procedure Act (APA), which should have guided the FDA to give notice of its action in the Federal Register, solicit comments from interested parties, and address meaningful comments with rationale before resolving the shortage.
The OFA asks that the court declare the FDA’s final action removing tirzepatide from the shortage list was contrary to the law under APA, to vacate the decision, and to not allow the FDA to take action against the organization for compounding tirzepatide.
Food and Drug Administration:
The FDA maintains that it had the right to proceed in removing tirzepatide from the shortage list. In response to the OFA’s accusation that the FDA ignored evidence that the shortage persists, the FDA issued a declaratory order citing evidence of Lilly’s current and future supply of the drug and its ability to meet demand.
The OFA’s complaint is as much about the FDA’s procedure for removing a drug from the shortage list as it is about the shortage itself. In response to this argument, the FDA maintains its authority to decide to change the status of a drug shortage without a comment period. It considers this process “adjudication,” not “rulemaking,” and does not consider the process to be in conflict with APA.
Eli Lilly:
Finally, Eli Lilly joined the lawsuit with the intention to bring it to an end. The company is protecting its interests–not only in the development of its tirzepatide drugs but in the “$23 million” spent to increase its manufacturing capacity to bring the drug out of shortage.
Additionally, Eli Lilly joined the suit with the belief that the FDA does not adequately represent the pharmaceutical company’s interests. It stated that the FDA is not seeking to defend its declaration ending the shortage but is only seeking to defend its executive authority. And, the FDA may not file an appeal if courts rule in favor of OFA.
What does this mean for compounders and providers?
The topic of tirzepatide (and GLP-1 semaglutide) continues to evolve rapidly. While this lawsuit is ongoing, there are a couple of key insights providers can take away as we follow the outcome.
Compounding Grace Period: After the FDA updated its shortage decision on December 19th, it reinstated a grace period for compounders to cease manufacturing. Of course, this is likely to change depending court proceedings, but here are the current guidelines:
State-licensed pharmacists or physicians compounding under section 503A of the FD&C act have 60 calendar days from the order, or until February 18, 2025.
Outsourcing facilities under section 503B have 90 calendar days from the order, or until March 19, 2025.
The FDA does not govern healthcare providers or provide grace periods for prescribers.
The Importance of Staying Informed: The outcome of this case may lead to wider implications for GLP-1s and compounding. For now, we recommend providers remain informed and able to adapt, should the future of their weight loss programs change. We’ll continue to provide updates as this case, along with other GLP-1 regulation, moves forward.
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