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FDA Sued by Outsourcing Facilities Over Abrupt Removal of Popular Weight Loss Drug From Shortage List

shadowy man covered in red tape being presented a lawsuit. in the background is a frustrated doctor and a slammed gavel with a bottle of mock medication with the FDA label on it
 

Key Ideas

  • The OFA asserts that the FDA took tirzepatide off the shortage list without proper notification, even though the agency admitted shortages are still ongoing.

  • The lawsuit contends that the FDA’s decision was arbitrary, bypassed the legal process, and appeared to favor special interests, potentially driving up drug prices.

 

FDA's Sudden Move Sparks Industry Outrage

The Outsourcing Facilities Association (OFA) has taken legal action against the FDA for removing tirzepatide—commonly used in weight loss treatments—from the federal drug shortage list without proper notice. Despite acknowledging existing shortages, the FDA’s decision has been called “reckless and arbitrary” by the OFA, which argues that this move deprives patients of access to critical compounded medications. The lawsuit demands that the FDA reinstate tirzepatide to the shortage list and allow compounding facilities to continue meeting patient demand while the case unfolds.


Did the FDA Favor Big Pharma?

The lawsuit further alleges that the FDA’s actions benefit special interests, possibly driving up the cost of tirzepatide, while patients across the nation still face difficulties accessing the drug. According to the OFA, the FDA failed to follow the required legal process by skipping public notice and input before making this decision. As tirzepatide shortages continue to impact patients, the lawsuit emphasizes the need for transparency in managing drug shortages and ensuring fair access to life-saving treatments.

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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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