Drugs

High Court Declines to Hear Medicare Drug Negotiation Challenge

The U.S. Supreme Court has declined to hear a series of pharmaceutical industry challenges to the federal government’s Medicare drug price negotiation program, preserving a key element of the Inflation Reduction Act and handing a setback to major drugmakers seeking to block the initiative.

The justices, without comment, rejected appeals brought by several pharmaceutical companies including Novo Nordisk, AstraZeneca, Bristol Myers Squibb, Novartis, Boehringer Ingelheim and Janssen Pharmaceuticals that argued the Medicare negotiation framework was unconstitutional.

The decision leaves intact lower court rulings that upheld the legality of the program, which was created under the 2022 Inflation Reduction Act. The law gave Medicare authority for the first time to directly negotiate prices for certain high-cost prescription medicines used by older Americans.

Industry groups and drugmakers had argued the program violated constitutional protections, including the First Amendment, Fifth Amendment due process and takings clauses, and improperly delegated government authority. The companies also contended the program effectively coerced manufacturers into accepting government-set prices under threat of steep financial penalties.

The Supreme Court’s refusal to hear the appeals allows the negotiation process to continue uninterrupted. The first negotiated prices for 10 drugs took effect this year, while additional rounds of negotiations are already underway. Federal officials have now negotiated prices for 25 medicines, including widely used diabetes and obesity drugs such as Ozempic, Wegovy and Rybelsus.

Although the legal setback narrows one avenue of attack for the pharmaceutical industry, additional litigation challenging the Medicare negotiation framework remains active in lower courts, according to reports.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome