FDA's removal of Ozempic, Wegovy from drug shortage list upheld
A federal judge on Wednesday ruled that the Food and Drug Administration's (FDA) decision to remove popular GLP-1s from its drug shortage list, ending the sale of compounded versions of the drugs, was lawful and that the agency acted correctly.
U.S. District Court Judge Mark Pittman found that the Outsourcing Facilities Association (OFA), an organization which represents compounding pharmacies, was wrong in its argument that the FDA's decision to remove GLP-1 drugs was 'arbitrary and capricious.'
Earlier this year, the FDA officially moved semaglutide, including popular versions like Ozempic and Wegovy, off of its drug shortage list, signaling the end of the condition which permitted compounding pharmacies to sell compounded versions of the drug.
The OFA had filed its lawsuit months before this, arguing the move to take GLP-1s off the shortage list was 'abruptly depriving patients of much needed treatment and artificially raising drug prices.' Their suit had initially been prompted by the removal of tirzepatide, marketed as Mounjaro and Zepbound, from the shortage list.
The OFA had argued that Novo Nordisk, which manufacturers semaglutide, even acknowledged that compounded drugs satisfied 20 percent of the market, but Pittman noted that it seems they misread the record they were citing multiple times.
'In cases where such mistakes can be attributed to either an accidental misread or an intentional mischaracterization, the Court prefers to attribute them to accident rather than malice,' wrote Pittman. 'However, Plaintiffs' consistent and pervasive pattern of similar mistakes, in this case and OFA I, has made it increasingly difficult for the Court to assume they are the product of accident.
Pittman took issue with some of the evidence presented by the plaintiffs, pointing to a 10-page chart that the plaintiffs created. It was not in the administrative record when the FDA considered its decision and thus it was not 'arbitrary' for the agency to not take the chart into consideration, the judge found.
The plaintiffs also pointed to a report by the telehealth company Hims & Hers, which sold compounded GLP-1s when the branded versions were in shortage, that relied on a survey involving tirzepatide and semaglutide products. Pittman noted there was no way to verify how many people took part in the survey or what it defined as an 'inability to access.'
Because the OFA didn't provide any new information, the court maintained it was not unreasonable for the FDA to give this survey 'less weight.'
The Hill has reached out to the OFA for comment.
The case was dismissed with prejudice, meaning this was a final judgment from Pittman. The OFA filed a notice of appeal on Wednesday in the U.S. District Court of Appeals for the Fifth Circuit.
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