FDA Reevaluates Removal of Tirzepatide from Drug Restriction List

On October 17, the FDA said it would reconsider the decision to remove tirzepatide (Zepbound, Mounjaro; Eli Lilly) from the drug shortage list, following a lawsuit brought by the Outsourcing Facilities Association (OFA). During the review and up to 2 months after the agency makes a final decision, the FDA does not intend to take action against the plaintiffs in the case of violations of the Federal Food, Drug, and Cosmetic Act, involving the combination of tirzepatide . as a drug that is “essentially a copy of an over-the-counter drug product,” “multiple drugs used in combination,” and “combined drugs that are essentially a copy of an FDA-approved product. ”

In a letter to Scott Brunner, CAE, CEO of the Alliance for Pharmacy Compounding, the FDA said there is no statement or court order that prevents the agency from taking action for any regulatory violations, including resolving whether a product is taken. low quality or unsafe by FDA inspection. In that letter, the FDA says that “FDA intends to treat the chemical in a consistent manner at this time, which means that the FDA does not intend to take action against the chemical for violations caused by the conditions.” above, at the same time and under all the same limitations as described in the FDA’s proposal and the court’s order.”

In the OFA case, the agency filed a lawsuit against the FDA for suddenly removing tirzepatide from the drug shortage list. The lawsuit claims the action was taken without the required notice and disputes the FDA’s warning of “domestic supply disruption.”¹

OFA said the FDA ignored evidence of continued shortages and withdrew the drug without input from affected parties and the public without good reason. Additionally, they claim that the FDA maintains that the shortage of tirzepatide continues and that it has “acted to benefit special interests, drive up drug prices, and deprive many people of access to needed medicine.” .”¹

According to the Administrative Procedure Act, organizations should propose and give notice of the measures taken, which includes seeking comments from the parties involved and the explanation of the final decision as well as providing feedback. The OFA claims that the FDA violated rulemaking requirements by announcing the shortage on its website and “depriving patients of access to the compounded drug.”¹

OFA wants transparency from the FDA, especially when it comes to drug shortages. The organization also states that outpatient services play an important role in drug shortages by helping to meet patient needs and keeping medication costs low. The FDA also states that compounding pharmacies can prepare many types of drugs listed on the FDA’s drug shortage list, as long as the compounded drug meets the requirements and conditions supported by federal law. As of October 21, there are 94 drugs missing, including semaglutide injection (Wegovy, Ozempic; Novo Nordisk), another glucagon-like peptide-1 inhibitor. As of October 2, tirzepatide is marked resolved, which has not changed since the trial.^1,2

References

1. Organization of Operations; 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 Food and Drug Commissioner. Civil Actions 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. Connecting with 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