Novo enters the ring in the legal fight against GLP-1 compounds

The continuous legal battle between the FDA and the pharmacies that make up the latter’s ability to produce blockbuster weight loss drugs, such as Semaglutide – marked by Novo Nordisk as Wegovy – and Tirzatide – marked by Eli Lilly has Zepbound. Following the elimination of these drugs from the list of FDA deficiencies, the Association of Facilities for outsourcing the Common Trade Group (OFA) has submitted lawsuits to continue to do the work. And now, Novo followed Lilly to enter into the nuanced legal situation.

Judge Mark T. Pittman of the US District Court for the Northern District of Texas decided on Wednesday that Novo Nordisk can intervene in case entered against the FDA by OFA In response to the elimination of Wegovy from the Agency’s deficiencies list, have reported several points of sale. This decision comes Two months After a court granted Lilly’s similar permission for a separate trial, OFA submitted to Zepbound’s elimination from the FDA deficiencies.

In the most recent of OFA processThe commercial organization calls the FDA decision “reckless and arbitrary decision”, claiming that it will deprive vital treatments for type 2 diabetes, obesity, cardiovascular disease and other serious medical conditions.

Pittman initially denied Novo’s request to get involved in the case, deciding it prematurely, but also reversed the decision on Wednesday, after the Danish pharma submitted a renewed motion. With Wegovy and Ozepomic away and away Top sale Products-over $ 8 billion in 2024 sales for first and $ 16.9 billion for the second-does not have a substantial interest in FDA insurance, effectively banning compounds to make elimination copies.

When the agency declares a drug in the absence, the Congress has established a doctor, pharmacist or an authorized outsourcing unit is allowed to compose the patient’s adequate medicine. With Semaglutide it is no longer in this status, composition pharmacies are no longer legally approved to make their own versions of the drug. According to the trial, since FDA placed semaglutides on the list of deficiencies in 2022, the patient’s request has been satisfied due to pharmacies and outsourcing facilities.

Last process mirrors closely OFA file in October 2024 When FDA ended the GLP-1 + GIP combo deficit of Eli Lilly, Tirzatid. The agency confirmed In December, that Tirzatide was no longer in a state of deficiency and gave them to the computers 90 days to stop their copying production. Lilly was finally approved to intervene In that struggle, which is before the same federal court.

OFA has since submitted a motion for a preliminary decision, argument The FDA made a decision applicable to the entire composition industry, which would be as a rule. The regulation for the agency comes with strict requirements, including the involvement of the public with a notification and coming period, in accordance with the Law on the Administrative Procedure.

Prior to the reversal of Chevron deferences last year, the questions turned on the FDA protocols for managing the drug deficit list. With pressures from parts like Ofa, the Agency they could face challenges In regulating the drug supply chain through this mechanism. GLP-1 weight loss space is a very thorny area with a The flowering shadows market Not only compounds, but by peptide producers, all researching, receiving the insightful demand that initially sent to Wegovy and Zepbound on the FDA deficiencies.