FDA To Reevaluate Removal of Tirzepatide From Drug Shortage List

On October 17, the FDA stated that it will reevaluate the decision to remove tirzepatide (Zepbound, Mounjaro; Eli Lilly) from the drug shortages list, following a lawsuit brought by the Outsourcing Facilities Association (OFA). During the reevaluation period and until 2 peeks after the agency makes a final decision, the FDA does not intend to take action against the plaintiffs in the case for the violation of the Federal Food, Drug, and Cosmetic Act, which includes the compounding of tirzepatide as a drug that is “essentially a copy of a commercially available drug product,” ”bulk drug substances used in compounding,” and “compounded drugs that are essentially a copy of an FDA‐approved drug product.”

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In a letter to Scott Brunner, CAE, CEO of the Alliance for Pharmacy Compounding, the FDA states that neither the statement nor the court’s order prevents the agency from taking action for any other violations of regulatory requirements, which includes addressing whether a product is deemed substandard quality or unsafe by FDA review. In the letter, the FDA states that the “FDA intends to treat compounders consistently at this time, meaning that FDA does not intend to take action against compounders for violations arising from the conditions above, for the same duration of time and subject to all the same limitations as described in FDA’s motion and the court’s order.”

In the lawsuit by the OFA, the organization filed litigation against the FDA for the sudden removal of tirzepatide from the drug shortage list. The lawsuit alleges that the action was taken without the required notice and disputes the FDA’s warning of “localized supply disruption.”¹

The OFA states that the FDA is ignoring evidence of an ongoing shortage and removed the drug without input from the affected parties and public and without meaningful rationale. Further, they state that the FDA confirms the shortage of tirzepatide remains ongoing and that “it acted to benefit special interests, raise drug prices, and deprive much of the public of access to a needed medicine.”¹

According to the Administrative Procedure Act, the agencies should propose and give notice of actions taken, which includes seeking comments from involved parties and an explanation of the final decision as well as addressing comments. The OFA alleges that the FDA skipped the requirements of rulemaking by announcing the shortage on its website and “depriving patients of access to the compounded drug.”¹

The OFA calls for transparency from the FDA, especially when it comes to drug shortages. The organization also claims that outsourcing facilities play a crucial role in drug shortages by helping to meet patient demands and keeping costs of medication low. The FDA also states that compounding pharmacies can prepare compounded versions of drugs that are listed on the FDA’s drug shortage list, provided that the compounded drug meets the requirements and conditions upheld by federal law. As of October 21, there are 94 drugs in shortage, which includes semaglutide injection (Wegovy, Ozempic; Novo Nordisk), another glucagon-like peptide-1 inhibitor. As of October 2, tirzepatide has been marked as resolved, which has not changed since the lawsuit.^1,2

References

1. Outsourcing Facilities Association; North American Custom Laboratories LLC D/B/A Farmakeio Custom Compounding v. United States Food and Drug Administration; and Dr. Robert M Califf, in his official capacity as Commissioner of Food and Drugs. Civil Action No. 4:24-cv-953. United States District Court For The Northern District of Texas, Fort Worth Division. Filed October 7, 2024. Accessed October 9, 2024. https://www.503bs.org/_files/ugd/90544a_956a40069f7c4b768199e187953cd15f.pdf

2. FDA. Compounding and the FDA: Questions and Answers. August 5, 2024. Accessed October 9, 2024. https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers