Appeals Court Revives Challenge to US Drug Price Negotiation Law

Overview

• The New Orleans-based 5th U.S. Circuit Court of Appeals ruled that a Texas judge wrongly dismissed the case due to jurisdiction issues.
• The lawsuit, brought by the Pharmaceutical Research and Manufacturers of America and others, claims the program gives excessive power to federal regulators.
• The program, part of the Inflation Reduction Act, mandates drug price negotiations for Medicare, covering 66 million people.
• Despite ongoing legal challenges, the first round of negotiated price cuts on 10 drugs, including Januvia and insulin products, is set to take effect in 2026.
• The appeals court's decision allows the National Infusion Center Association's claims to be heard, disagreeing with the initial ruling that disputes must first go to the HHS.