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The pharmaceutical companies’ fight against the price negotiation provisions of the Anti-Inflation Act has been met with little success: Nearly a dozen lawsuits have been filed, none of which have achieved their goals.
Still, the pharmaceutical industry is continuing its legal pursuit, and many of the biggest companies have vowed to continue. The Centers for Medicare and Medicaid Services has already Negotiations Complete The 10 drugs initially selected for Medicare coverage in 2026 were primarily I waved my hand and drove them away Financial impact from recent earnings call.
But pharmaceutical executives have long complained that price caps limit innovation and discourage research and development. Fears may be exaggerated.
On the legal side, debate has centered on the constitutionality of the IRA; Cases to be addressed The First, Fifth and Eighth Amendments. There are a lot of lawsuits going on around the country, and the pharmaceutical companies Pursued a strategy This could see one of the cases end up in the Supreme Court.
However, the judges have not been sympathetic to the pharmaceutical companies, and all of the rulings to date have The lawsuit was dismissed..
What’s still pending
Merck, which filed a lawsuit in Washington, D.C., to block the negotiating program from moving forward, is still waiting for an initial decision. Merck’s diabetes drug Januvia was one of 10 products selected for 2026. Maximum discount rate In some cases, Merck said negotiations with the government left it with no choice but to fight back legally.
“We remain concerned that the IRA’s pricing policies will have a significant deterrent effect on future innovation and research investment, ultimately affecting patients’ access to new medicines and therapies,” a Merck spokesman said in an emailed statement.
The companies that have already been sentenced are appealing the rulings. Rather than admitting defeat, appeals have put big pharma back into the waiting game. Earlier this year, four companies – Bristol-Myers Squibb, Johnson & Johnson, Novo Nordisk and Novartis – filed suit against the company, saying they had not filed suit against the company. The lawsuits were consolidated. This is to avoid duplication of discussion.
Bristol-Myers Squibb is taking a constitutional approach: Eliquis, a blood thinner it co-owns with Pfizer, is also one of the drugs hardest hit in the 2026 plan, with its negotiated price cut of 56% from its 2023 list price.
“BMS is disappointed with the Court’s decision and has appealed,” a BMS spokesperson told PharmaVoice in an email. “We remain concerned that IRA’s so-called ‘negotiation’ program violates the U.S. Constitution and has a significant impact on future innovation for patients. BMS will continue to work with CMS on implementation as required by law.”
While it awaits legal action, Novartis argues that the IRA stifles research and development progress.
“This program will stifle innovation and put future medicines at risk, harming the millions of patients who rely on the pharmaceutical industry to find life-saving treatments,” Novartis said last year. First to file a lawsuit.
Appeals filed by Boehringer Ingelheim and AstraZeneca are also pending following the dismissal of the cases.
Industry group PhRMA, along with the National Association of Infusion Centers and the World Colon Cancer Society, Rejected It filed a lawsuit against CMS earlier this year. AppealedThe lawsuit argued that the bargaining program violated Eighth and Fifth Amendment rights, but the court ruled it had no jurisdiction and the case was appealed. Fifth Circuit court.
“I expect[pharmaceutical companies]will continue to litigate in multiple courts and on multiple theories,” Judith Waltz, a health care partner at the law firm Foley & Lardner, told PharmaVoice. “Certain courts may view the underlying law and the agency’s implementation efforts differently, and pharmaceutical companies may get ‘lucky’ with certain courts. And if pharmaceutical companies can resolve disagreements in the circuits, they may have a better chance of winning an appeal to the Supreme Court. Litigation can also slow down the government’s implementation process. Even if it doesn’t prohibit a particular approach, it may cause the government to hesitate to move forward with a particular angle.”
