In a legal showdown that had the healthcare industry on the edge of its seat, a federal court judge delivered a dramatic ruling on Friday. The U.S. Chamber of Commerce’s attempt to secure a preliminary injunction against the Inflation Reduction Act’s (IRA) Drug Price Negotiation Program, a linchpin of the Biden administration’s Medicare cost-cutting efforts, faced its first legal litmus test.
Judge Michael Newman of the Southern District of Ohio, in a decision that left many onlookers surprised, shot down the Chamber of Commerce’s bid. In his order, Judge Newman emphasized that the plaintiffs failed to establish both a strong likelihood of success and irreparable harm in their initial lawsuit challenging various provisions of the IRA.
Adding to the intrigue, this ruling came just ahead of the looming October 1st deadline, when pharmaceutical companies were required to register their participation in the IRA program, as mandated by the Centers for Medicare and Medicaid Services (CMS).
The Chamber of Commerce had thrown down the gauntlet, launching its lawsuit against the Department of Health and Human Services (HHS) in June 2023. Their legal challenge painted a picture of constitutional conflict, alleging that the IRA’s Drug Price Negotiation Program trampled on principles of limited government, property rights, the rule of law, and the separation of powers.
Furthermore, the Chamber argued that the program ran afoul of the Fifth Amendment, which protects private property from government appropriation without “just compensation.” However, Judge Newman was not swayed, contending that the plaintiffs failed to demonstrate that the program could never be constitutionally valid under the Fifth Amendment Due Process Clause.
In a courtroom drama filled with twists, the Chamber of Commerce also contended that the HHS program essentially left pharmaceutical companies with no choice but to accept the government’s “maximum fair price,” resulting in drug prices that were effectively confiscatory.
Once again, Judge Newman challenged this notion, asserting that companies had the option to opt out of the Medicare system entirely if they disagreed with the negotiated prices.
The IRA, signed into law by President Joe Biden in August 2022, aimed to slash approximately $25 billion in government drug spending over the next eight years. By August 2023, CMS had revealed the first 10 drugs subject to price negotiations.
Among them were some of the most widely prescribed medications, including Eliquis, Jardiance, and Imbruvica. These drugs alone had cost the U.S. government a staggering $50 billion from June 2022 to June 2023.
Notably, the Chamber of Commerce wasn’t the only player in this high-stakes legal drama. Several pharmaceutical heavyweights, including Merck, BMS, J&J, AstraZeneca, and Novartis, had also opposed the Medicare Drug Price Negotiation Program, ensuring that the battle over drug pricing would continue to captivate the healthcare landscape.