A commerce group representing compounding pharmacies has filed a lawsuit towards the Meals and Drug Administration (FDA) for eradicating semaglutide, the energetic ingredient in Ozempic, from its drug scarcity record.
Final week, the FDA formally moved Ozempic and Wegovy off its scarcity record 4 months after the drug was discovered to obtainable within the U.S. Throughout the time that semaglutide has been on the record, compounding pharmacies have been capable of promote copycat variations of the drug at a a lot decrease price, enabling telehealth firms and medical spas to money in on the high-demand product.
The Outsourcing Services Affiliation (OFA), nonetheless, just isn’t accepting the scarcity is over, stating in its lawsuit filed on Monday that the FDA’s resolution to take away semaglutide from the scarcity record is “reckless and arbitrary.” The commerce group filed the same lawsuit when tirzepatide, the energetic ingredient within the GLP-1 medicine Mounjaro and Zepbound, have been faraway from the drug scarcity record.
The OFA’s go well with argues that the provision of Ozempic and Wegovy can’t meet present demand and thus the scarcity just isn’t 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 acknowledged, referring to a compounding firm that can also be a plaintiff within 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 resolution to take away semaglutide from the scarcity record be declared illegal and that the motion be reversed.
The Hill has reached out to the FDA for a response, however federal well being businesses usually don’t touch upon ongoing litigation.
