FORT WORTH, Texas--(BUSINESS WIRE)--The Outsourcing Facilities Association (OFA) has filed a lawsuit against the U.S. Food and Drug Administration (FDA) regarding the agency’s sudden removal of Tirzepatide, a GLP-1 medication used to treat diabetes and obesity, from the federal drug shortage list, an action that the suit asserts was taken without the required notice and despite the agency’s own warning of “localized supply disruptions.”
When a drug is on FDA’s drug shortage list, outsourcing facilities by law may help address the drug shortage by producing an “essential copy” version of the shortage drug using bulk drug substances. In so doing, outsourcing facilities help alleviate the drug shortage to help meet patient demand and keep costs lower for medications.
OFA’s lawsuit, filed in the U.S. District Court for the Northern District of Texas, seeks a determination that the FDA’s action was contrary to law and to have it vacated immediately. OFA is also seeking a temporary order that would enjoin FDA from taking action against OFA’s members for making compounded versions of Tirzepatide during the pendency of the lawsuit.
In the lawsuit, OFA calls for greater transparency by the FDA in defining and managing drug shortages, especially as drug shortages continue to worsen and costs continue to rise for patients across the country, with this class of medication being too costly for many to afford. The FDA removed Tirzepatide from the drug shortage list without any filing in the Federal Register or opportunity for comment from the public; FDA simply announced on its website that the drug had been taken off of the list and did so at the close of business on Oct. 2, at the start of the Jewish high holy day Rosh Hashanah.
“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. “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.”
The complaint can be found here.
About Outsourcing Facilities Association
The Outsourcing Facilities Association (OFA) is the trade association representing FDA-registered 503B outsourcing facilities, which focus on providing hospitals, physicians and patients with critically needed compounded medications. OFA works with industry, government and health care providers to advocate for outsourcing facilities and their products. For more information, visit www.503Bs.org.
