Frier Levitt continues to closely monitor ongoing FDA litigation related to drug shortages, and we wanted to share an important update in the case between the Outsourcing Facilities Association (OFA) and FDA (Outsourcing Facilities Association (OFA) v. FDA, 4:24-cv-00953 (N.D. Tex.)) regarding the tirzepatide shortage declaration.
As of yesterday, March 5, 2025, Judge Pittman entered a restricted document on the case’s docket which purports to be an order denying OFA’s request for a preliminary injunction. The entry states “SEALED OPINION & ORDER denying MOTION for Injunction (Ordered by Judge Mark Pittman on 3/5/2025).” While the supposed order itself is restricted and not available for public viewing, one can surmise that the FDA’s decision to declare the tirzepatide shortage to be over officially remains in place. Based on recent guidance from the FDA, outsourcing facilities will no longer be able to compound or distribute compounded tirzepatide after March 19, 2025, while compounding pharmacies may be prohibited from compounding or dispensing tirzepatide effective immediately (the FDA had previously stated that it would not take action against compounding pharmacies for violations of the Food, Drug & Cosmetic Act until February 18, 2025, or the date of the court’s decision on the preliminary injunction motion, whichever was longer).
What This Means for Compounders
While the exact text of the order is not publicly available yet, and while many observers anticipate OFA will file an appeal, both compounding pharmacies and outsourcing facilities will have to take immediate action.
For outsourcing facilities, while they can continue to compound and distribute tirzepatide until March 19, after that date, they will no longer be able to compound using bulk API tirzepatide (as tirzepatide is not on the FDA’s Bulks List for 503B facilities, nor is it on the Interim Bulks List).
For compounding pharmacies, while they can no longer regularly compound products that are “essentially a copy” of the FDA-approved version, options may exist to produce products that are not essential copies, and that produce a clinical difference for the patient as compared to the FDA-approved version. The FDA has produced guidance on the standards for determining what is or is not to be consider “essentially a copy” of an FDA-approved drug.
Manufacturer Reaction
This ruling is likely to have a big impact on manufacturer activities. Eli Lilly has previously sent out several rounds of “cease-and-desist” letters, directing pharmacies, outsourcing facilities and others to stop compounding tirzepatide now that the shortage has been declared ended. Eli Lilly has also previously sued compounders, prescribers and others over allegations related to the compounding, promotion or sale of compounded tirzepatide products. We expect that Eli Lilly will react aggressively to this ruling, potentially seeking to take direct action against compounders that produce tirzepatide products in alleged violation of federal compounding laws. It is also possible Eli Lilly may refer compounders to the FDA and state Boards of Pharmacy for potential enforcement.
Impact on Other Cases
In addition to the litigation related to tirzepatide, a separate lawsuit was recently filed by OFA related to FDA’s decision on February 21, 2025, to remove semaglutide from the shortage list (Outsourcing Facilities Association et al v. Food and Drug Administration et al, 4:25-cv-00174 (N.D. Tex.)). In that case (also pending before Judge Pittman), OFA is similarly seeking a preliminary injunction to prevent the enforcement of the shortage declaration. Given the similarity between the legal claims and timing in the two cases, observers are concerned about not only whether FDA will agree to extend the grace period for compounding semaglutide while the case progresses as it had done in the tirzepatide case (currently, compounding pharmacies have until April 22, 2025 to cease compounding semaglutide, while outsourcing facilities have until May 22, 2025), but also whether Judge Pittman will similarly deny this preliminary injunction application altogether.
How Frier Levitt Can Help
In addition to developing strategies to continue to challenge FDA’s decisions, Frier Levitt can help guide compounders on compliance considerations, including the rules around compounding products that are not essentially a copy of commercially available drugs. Frier Levitt has worked with many compounders and other stakeholders to respond to manufacturer cease-and-desist letters, avoid exposure to manufacturers, and ensure compliance with state and federal rules. If you are compounding tirzepatide or semaglutide, we urge you to contact us today.
