Whether the IRA implicates an interest of pharmaceutical manufacturers that is protected by the Due Process Clause

In the Inflation Reduction Act of 2022 (IRA) , Congress enacted the so -called “Drug Price Negotiation Program,” which requires pharmaceutical manufacturers to sell certain selected drugs at steep ly discount ed price s mandated by the Secretary of Health and Human Services. A manufacturer whose drug is subject to this government -dictated price must —on pain of massive civil penalties —make that price available in private transactions with individuals, pharmacies, hospitals, and other non-governmental participants in Med icare. Notably, the agency ’s key decisions interpreting and implementing the IRA are not subject to notice -and-comment rulemaking on the front end; nor are they judicial ly reviewable on the back end . There is accordingly no way for a manufacturer who objects to the selection of its drug, or to the price set for the drug by the agency, to ensure that its objections are taken into account. Petitioner s manufacture one of the drug s that will be subject to government -set prices in 2026. The price set for that drug will affect billions of dollars’ worth of sales in private -party transactions. In the decision below, the court of appeals rejected petitioners’ due process challenge —without even considering whether the IRA’s complete lack of procedures fall s below minimum constitutional standards —on the ground that the statute does not affect petitioners’ constitutionally protected interests. The question presented is: Whether the IRA implicates an interest of pharmaceutical manufacturers that is protected by the Due Process Clause . (ii)