FDA sued over ‘reckless and arbitrary’ semaglutide decision
The Outsourcing Facilities Association (OFA), a Texas-based trade association focused on distributing compounded medications throughout the healthcare industry, has sued the U.S. Food and Drug Administration (FDA) for removing semaglutide from the federal drug shortage list.
When drugs are on the FDA’s drug shortage list, outsourcing facilities such as the ones represented by OFA have a green light to help produce their own “essential copy” versions of those drugs. Compounded drugs are not technically approved by the FDA, though they are still required to meet certain conditions predetermined by the FDA. Removing something from the drug shortage list typically means compounders are no longer able to sell their “essential copy” versions.
In its lawsuit, filed Feb. 24, the OFA described the decision as “reckless and arbitrary” and said it will “deprive patients of a vital treatment for type 2 diabetes, obesity, cardiovascular disease and other serious medical conditions.” The group also alleged that significant issues remain with the supply of these drugs, saying FDA officials “acted to benefit special interests.”
“If ever an agency action were arbitrary, capricious, and contrary to law, this is it,” the OFA added in its lawsuit.
Additional context
The lawsuit comes just days after the FDA officially ended a years-long shortage of Wegovy and Ozempic, two popular prescription-only semaglutide injections.
Semaglutide is a GLP-1 receptor agonist being sold by Novo Nordisk under the brand names Wegovy, Ozempic and Rybelsus. GLP-1 receptor agonists were originally developed to treat diabetes, but they are being used more and more to help obese and overweight patients lose weight. In addition, semaglutide has specifically been linked to consistent health benefits for heart failure patients and patients undergoing heart bypass surgery.
According to Novo Nordisk, the company is now producing these drugs around the clock, seven days a week. In addition, it has invested billions of dollars in expanding its manufacturing facilities.
If this story sounds familiar, it’s because the OFA also filed a lawsuit against the FDA when tirzepatide was removed from the federal drug shortage list in 2024.
Click here to read the OFA lawsuit.
Click here for information on FDA policies related to the federal drug shortage list and compounders.
The FDA is not publicly commenting on the OFA lawsuit at this time.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.