The Inflation Reduction Act passed by Congress in 2022 authorized the Department of Health and Human Services, for the first time, to negotiate the price of single-source drugs that would be covered by the Medicare program. Under the drug price negotiation program, the Department must designate up to 10 high-cost single-source drugs used in the Medicare Part D prescription drug program for the first round of negotiations, which are to begin on October 1, 2023, and continue through August 1, 2024. If the negotiations are successful, the drugs would be available to seniors enrolled in Part D beginning in 2026. For subsequent years, HHS must select additional single-source drugs for negotiations, expanding to include Medicare Part B drugs for the 2028 plan year.
The Chamber of Commerce and three regional and local chambers filed suit seeking to declare the drug price negotiation program unconstitutional. They then filed a motion for preliminary injunction asking the court to halt the program before the October 1, 2023, start date for negotiations on the ground that the program violated drug manufacturers’ due process rights. Public Citizen, joined by Patients for Affordable Drugs Now, Doctors for America, Protect Our Care, and Families USA, filed an amicus brief in support of the government’s opposition to the preliminary injunction motion. The brief explains that seniors continue to struggle affording the high cost of drugs for which there is no competition from generics, often resulting in seniors’ forgoing medications or sacrificing other necessities. The brief argues that grant of an injunction would not be in the public interest because it would risk delay in the 2026 start date for the program and, thus, would create a risk of irreparable harm to seniors’ health and finances.