Pharma’s fight against the Inflation Reduction Act’s drug price negotiation provisions have fallen a little flat. After nearly a dozen lawsuits, none have been able to hit the target.
Still, the pharma industry persists in its legal pursuit, and many pharma giants have vowed to continue. The Centers for Medicare and Medicaid Services has already completed negotiations for the first 10 drugs selected in Medicare’s 2026 coverage, and executives largely waved off the financial impact in recent earnings calls.
However, pharma executives have long cried that capping drug prices will limit innovation and put a damper on R&D. However, research has found those fears may be overblown.
On the legal front, arguments have centered on the constitutionality of the IRA, with cases tackling the First, Fifth and Eighth amendments. With so many lawsuits across the country, pharma has pursued a strategy that could potentially land one of the cases in front of the Supreme Court.
But judges have not been sympathetic to pharma, and all decisions rendered so far have rejected the lawsuits.
What’s still pending
Merck & Co., which filed its case in D.C., is still awaiting an initial decision for its quest to block the negotiation program from moving forward. Merck’s diabetes drug Januvia is among the 10 selected for 2026 and had the biggest percentage discount among them. Merck has said the negotiations with the government didn’t give the pharma much choice but to fight back legally.
“We remain concerned that [the] IRA’s price-setting policy will have a significant chilling effect on future innovation and research investment, which will ultimately impact patient access to new medicines and cures,” a Merck spokesperson said via email.
Companies that have already received a decision have appealed. Rather than accepting defeat, the appeals put Big Pharma back in the waiting game. Earlier this year, four of them — Bristol Myers Squibb, Johnson & Johnson, Novo Nordisk and Novartis — combined their lawsuits to avoid overlapping arguments.
Bristol Myers Squibb is taking a Constitutional approach. The company’s blood thinner Eliquis, which it co-owns with Pfizer, is also among one of the drugs hit hardest in the 2026 plan year, with a 56% discount of negotiated price from the 2023 list price.
“BMS was disappointed with the court's decision and appealed,” a BMS spokesperson told PharmaVoice in an email. “We maintain our concerns that the IRA's so-called 'negotiation' program is in violation of the U.S. Constitution and will have a serious impact on future innovation for patients. BMS continues to work with CMS on implementation as required by the law.”
Novartis, i awaiting the legal decision, maintains the IRA will thwart R&D breakthroughs.
“This program will stifle innovation and jeopardize the creation of future medicines — harming the millions of patients who count on the pharmaceutical industry to discover life-saving treatments,” Novartis said in a statement last year when it first filed its suit.
Appeals brought by Boehringer Ingelheim and AstraZeneca are also pending following tossed suits.
Industry association PhRMA, alongside the National Infusion Center Association and the Global Colon Cancer Association, was also rejected earlier this year in its case against CMS, but has appealed. The case argued the negotiation program violated Eighth and Fifth amendment rights, but the court ruled it didn’t have jurisdiction, pushing the appeal to the Fifth Circuit court.
“I expect that [pharmas] will continue to pursue litigation in multiple venues and with multiple theories,” Judith Waltz, healthcare partner with Foley & Lardner LLP, told PharmaVoice. “A particular court may see the underlying law and the agency’s efforts at implementation differently, and pharma companies could ‘get lucky’ in a particular court. And if pharma can get a split in circuits, there may be a better shot at having an appeal to the Supreme Court accepted. Litigation might also delay the government’s process of implementation – even if a particular approach is not enjoined, it may give the government pause about moving forward with a particular angle.”
