Novo Nordisk has joined the long list of biopharma companies that are challenging drug price negotiation provisions in the Inflation Reduction Act (IRA).
Novo filed a lawsuit in federal district court in New Jersey on Friday, claiming that the program violates the First Amendment and the Fifth Amendment.
Novo’s suite of insulin treatments for diabetes, including NovoLog and Fiasp, are among 10 drugs subject to Centers for Medicare & Medicaid Services (CMS) price negotiations in 2026. The insulin products accounted for $2.6 billion in Medicare Part D spending from June 2022 to May 2023, according to CMS data.
Two days after filing its suit, Novo said it would meet the Oct. 1 deadline for agreeing to participate in the negotiation process.
“While we do not believe the implementation of drug price negotiation provisions of the IRA is the right approach to help ensure patients living with diabetes can afford our insulins, we will comply with the law,” a company spokesperson wrote.
Also on Friday, an Ohio federal judge rejected the U.S. Chamber of Commerce’s motion for an injunction to block the start of the price negotiation program. The court still must decide on the Chamber's claim that the program is unconstitutional.
In its lawsuit, Novo claims that the CMS has “unlawfully deemed” six of its insulin treatments as a single biologic product subject to “price controls.”
“These medications are different drugs with different formulations and different requirements for approval, each separately licensed by the FDA,” Novo said in a statement.
Other companies with drugs on the CMS negotiation list that have filed lawsuits are AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Johnson & Johnson, Novartis and Merck.
Still, many of the companies with drugs on the list have said they'll participate in the negotiation process. On Monday, a J&J spokesperson said the company "submitted all required information in compliance with CMS’s drug price setting guidance and will continue to demonstrate the value of our treatments to patients."
Other companies that have agreed to participate in the process include AZ, BMS and Merck.
In addition to signing onto the price negotiation program on Sunday, companies are required on Monday to provide data that will help the CMS determine a fair price. Companies not participating in the program must allow generic or biosimilar competition, according to CMS guidelines.