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Outsourcing Facilities Association Sues FDA Over Sudden Removal of Tirzepatide From Drug Shortage List

Key Takeaways

  • The OFA claims the FDA removed tirzepatide from the shortage list without proper notice, despite acknowledging ongoing shortages.
  • The lawsuit argues the FDA's decision was arbitrary, lacked lawful process, and favored special interests, potentially raising drug prices.
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The lawsuit alleges that the action was taken without the required notice and disputes the agency’s warning of “localized supply disruption,” while calling for more transparency.

The Outsourcing Facilities Association (OFA) filed a lawsuit against the FDA for the sudden removal of tirzepatide (Zepbound, Mounjaro; Eli Lilly) from the federal drug shortage list. The lawsuit alleges that the action was taken without the required notice and disputes the agency’s warning of “localized supply disruption,” according to a news release from OFA.1

Tirzepatide, FDA, Drug Shortage, Lawsuit | Image Credit: Cynthia - stock.adobe.com

Image Credit: Cynthia - stock.adobe.com

“The FDA’s removal of tirzepatide from the shortage list without the due process of proper federal notice, at a time when they acknowledge that shortages still exist, is the definition of arbitrary and capricious,” said Lee H Rosebush, chairman of OFA, in the news release. “The agency’s decision will have tremendous implications across the nation for patients and physicians, as well as the outsourcing facilities that made an enormous investment to meet patient demand in light of product shortages and delays.”1

The lawsuit alleges that the decision is “reckless and arbitrary” and “lacking any semblance of lawful process.” According to the FDA, compounding facilities may prepare compounded versions of a drug listed on the FDA’s drug shortage list, provided the compound drugs meet the conditions of the federal law. As of October 9, there are currently 117 drugs on the drug shortage list, including amoxicillin powder for suspension, clonazepam, and semaglutide injection (Wegovy, Ozempic; Novo Nordisk). As of October 2, tirzepatide has been marked as resolved.2,3

In the lawsuit, the OFA is seeking that the action was contrary to law and that decision will have to be vacated immediately; the OFA is also asking for a temporary order allowing members of the OFA to make compounded versions of the drug during the pending lawsuit.1

In the lawsuit, the OFA alleges “ignoring evidence that the shortage persists, [the] FDA removed tirzepatide from the shortage list without notice, without soliciting input from affected parties and the public, and without meaningful rationale. Indeed, the agency confirmed that there remains a tirzepatide shortage and that it acted to benefit special interests, raise drug prices, and deprive much of the public of access to a needed medicine.”3

According to the OFA filing, the Administrative Procedure Act states that agencies should propose and give notice of actions taken to the Federal Register, seek comments from parties involved, and explain the final decision and address comments on the decision. The OFA states that the “FDA skipped past every single requirement of reasoned rulemaking when it threw up a notice on its website removing tirzepatide from the shortage list—thereby depriving patients of access to the compounded drug.”3

The lawsuit demands transparency of the FDA, especially when it comes to defining and maintaining drug shortages, especially as the shortages continue to worsen for patients across the United States. The OFA claims that outsourcing facilities play a critical role in drug shortages by meeting patient demands and helping to keep costs lower for medication.1

REFERENCES
1. Outsourcing Facilities Association Sues FDA Over Sudden Removal of Tirzepatide from Drug Shortage List. News release. OFA. October 8, 2024. Accessed October 8, 2024. https://www.businesswire.com/news/home/20241008699576/en/Outsourcing-Facilities-Association-Sues-FDA-Over-Sudden-Removal-of-Tirzepatide-from-Drug-Shortage-List
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
3. Outsourcing Facilities Association; North American Custom Laboratories LLC D/B/A Farmakeio Cutom Compounting 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
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