FDA is reconsidering removing tirzepatide from the drug shortage list

On October 17, the FDA announced that it would reevaluate the decision to remove tirzepatide (Zepbound, Mounjaro; Eli Lilly) from the drug shortage list after the Outsourcing Facilities Association (OFA) filed a lawsuit. During the reevaluation period and until two days after the agency's final decision, FDA does not intend to take action against the plaintiffs in the case of violation of the Federal Food, Drug, and Cosmetic Act, which includes the composition of tirzepatide as a drug , which is “substantially a copy of a commercially available drug product,” “bulk drug substances used in manufacturing,” and “compound drugs that are substantially a copy of an FDA-approved drug product.”

In a letter to Scott Brunner, CAE, CEO of the Alliance for Pharmacy Compounding, FDA states that neither the declaration nor the court order prevents the agency from taking action on other violations of regulatory requirements, including whether a product What is classified as acceptable is inferior quality or unsafe according to FDA testing. In the letter, the FDA states that “FDA intends to treat compounders consistently at this time, which means that FDA does not intend to take action against compounders for violations arising from the above conditions for the same period and subject to the same period.” “The same limitations as described in the FDA's application and the court order apply.”

In OFA's lawsuit, the organization filed a lawsuit against the FDA over the sudden removal of tirzepatide from the drug shortage list. The lawsuit claims the action was taken without the required notice and challenges the FDA's warning of a “local supply disruption.”¹

The OFA alleges that the FDA ignored evidence of an ongoing shortage and removed the drug from the market without input from affected parties and the public and without meaningful justification. Additionally, they state that the FDA acknowledges that tirzepatide shortages continue and that “it has acted to help special interests raise drug prices and deny much of the public access to a needed drug.”¹

According to the Administrative Procedure Act, the authorities should propose and announce measures taken, which also include obtaining comments from those involved and explaining the final decision as well as processing comments. The OFA alleges that the FDA skipped the rulemaking requirements by disclosing the defect on its website and “denying patients access to the compounded drug.”¹

The OFA demands transparency from the FDA, particularly when it comes to drug shortages. The organization also claims that outsourcing facilities play a critical role in drug shortages by helping to meet patient needs and keep drug costs low. The FDA also states that compounding pharmacies may prepare compounded versions of drugs listed on the FDA's drug shortage list, provided that the compounded drug meets the requirements and conditions of federal law. As of October 21, there is a shortage of 94 drugs, including semaglutide injections (Wegovy, Ozempic; Novo Nordisk), another glucagon-like peptide-1 inhibitor. As of October 2nd, tirzepatide is considered resolved, which has not changed since the lawsuit was filed.^1.2

References

1. Outsourcing Facilities Association; North American Custom Laboratories LLC D/B/A Farmakeio Custom Compounding v. U.S. 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. Submitted 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.