FDA Under Fire Over Tirzepatide

By Ziya Sangha

The Outsourcing Facilities Association (OFA) recently filed a lawsuit against the Food and Drug Administration (FDA) over restrictions on compounded versions of tirzepatide, an alternative breakthrough drug for treating type 2 diabetes and obesity in adults. The recently introduced drug has been a promising treatment for weight loss and other conditions. However, it is not cheap, causing compound pharmacies to come to the rescue. 

Compound pharmacies are specialized pharmacies that customize medications to specific patient needs, including altering dosages, combining medications, or offering more affordable alternatives. Like with tirzepatide, some compound pharmacies have begun offering alternative mixes of the weight-loss drug to make it more accessible to patients who can’t afford the more popular versions, such as Ozempic. However, the FDA intervened with this ongoing initiative, following their sudden decision to pull tirzepatide off the short supply list. 

On October 2nd, the FDA announced that tirzepatide was no longer in shortage, after a year being so, which impacted compound pharmacies significantly. When a drug is placed on the FDA short supply list, restrictions on compounding that drug are lenient. This benefits compound pharmacies as they can create treatments that mimic these drugs at lower costs for patients who need the medication. However, pulling the drug from the short supply list re-enacts these restrictions, which include limits on the distribution of compound treatments or creating identical copies of the drug. So, when tirzepatide was pulled from the list, the OFA took a stance. 

The OFA, a trade association aimed at providing patients with critically needed compounding medications, sued the FDA after their decision to pull tirzepatide off the short supply list. The association claims the drug is still in short supply, and should therefore remain on the short supply list. Additionally, OFA’s Chairman Lee H. Rosebush shared that, “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.” This further emphasizes the irrationality in the FDA’s decision. Additionally, the OFA advocates in their lawsuit for the recognition of the problems that would result from removing the drug from the short supply list, which includes increased drug prices, which would reduce access for many patients. 

As a result of the lawsuit, the FDA reconsidered its decision on tirzepatide and permitted compound pharmacies to continue to provide compounded versions of tirzepatide. However, this decision remains temporary, which worries consumers of the compounded versions of tirzepatide. Simone Williams, a consumer of this compounded drug, spoke with NBC News on her stance on the FDA’s decision: “Until the FDA makes a solid decision, I’m still going to be nervous.” She previously cited how she turned to this drug because it was the only affordable medication. So, while the problem may be temporarily resolved, consumers of compounded tirzepatide and compound pharmacies remain vigilant in advocating for the continuation of the distribution of these compounded medications.

Works Cited

“Compounding Pharmacies Can Resume Making Tirzepatide as FDA Reconsiders Shortage.” NBC News, 14 Oct. 2024, https://www.nbcnews.com/health/health-news/compounding-pharmacies-can-resume-making-tirzepatide-fda-reconsiders-s-rcna174551.

“Compounding When Drugs Are on FDA’s Drug Shortages List.” FDA, Dec. 2024. www.fda.gov, https://www.fda.gov/drugs/human-drug-compounding/compounding-when-drugs-are-fdas-drug-shortages-list.

Fischer, Kristen. “What Is a Compounding Pharmacy?” WebMD, https://www.webmd.com/drug-medication/what-is-compounding-pharmacy. Accessed 26 Dec. 2024.

“Outsourcing Facilities Association Sues FDA Over Sudden Removal of Tirzepatide From Drug Shortage List.” Pharmacy Times, 14 Oct. 2024, https://www.pharmacytimes.com/view/outsourcing-facilities-association-sues-fda-over-sudden-removal-of-tirzepatide-from-drug-shortage-list.

“Tirzepatide.” Drugs.Com, 12 Nov. 2024, https://www.drugs.com/tirzepatide.html.