A federal judge in Texas has upheld the FDA’s decision to remove GLP-1 drugs, including Novo Nordisk’s Ozempic and Wegovy, from its drug shortage list, rejecting a bid by compounding pharmacies to allow them to continue making copies of the drugs, The Hill reported June 18.
U.S. District Judge Mark Pittmann ruled June 17 that the FDA had acted appropriately when it determined that supply conditions had improved and that the agency had considered relevant evidence.
In April, Mr. Pittman denied the compounding pharmacies’ bid for an injunction in April, blocking them from making copies of the drugs while litigation was pending.
A lawsuit brought by the Outsourcing Facilities Association alleged that the FDA acted recklessly in removing semaglutide from the shortage list, saying there was evidence the drugs were still in short supply.
Mr. Pittman also rejected an earlier challenge in May brought by the same association over the FDA’s removal of Eli Lilly’s Zepbound and Mounjaro from the shortage list. The OFA then appealed the ruling.
