Drug compounders sue over weight loss drugs' removal from FDA shortage list

A trade group representing compounding pharmacies has filed a lawsuit against the Food and Drug Administration (FDA) for removing semaglutide, the active ingredient in Ozempic, from its drug shortage list.

Last week, the FDA officially moved Ozempic and Wegovy off its shortage list four months after the drug was found to available in the U.S. During the time that semaglutide has been on the list, compounding pharmacies were able to sell copycat versions of the drug at a much lower cost, enabling telehealth companies and medical spas to cash in on the high-demand product.

The Outsourcing Facilities Association (OFA), however, is not accepting the shortage is over, stating in its lawsuit filed on Monday that the FDA's decision to remove semaglutide from the shortage list is "reckless and arbitrary." The trade group filed a similar lawsuit when tirzepatide, the active ingredient in the GLP-1 drugs Mounjaro and Zepbound, were removed from the drug shortage list.

The OFA's suit argues that the supply of Ozempic and Wegovy cannot meet current demand and thus the shortage is not over.

"FDA’s Delisting Action will (if it stands) cause OFA’s members to fail to capitalize on their investment. It will destroy their revenues, and those of FarmaKeio, from the sale of compounded drugs that are in acute demand," the lawsuit stated, referring to a compounding company that is also a plaintiff in the case. "Even if Plaintiffs prevail in this action, they will be unable to recoup lost revenues or profits from the federal government."

The OFA is asking that the FDA's decision to remove semaglutide from the shortage list be declared unlawful and that the action be reversed.

The Hill has reached out to the FDA for a response, but federal health agencies typically do not comment on ongoing litigation.

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