Whether the government's mandatory drug price negotiation program under the Inflation Reduction Act violates pharmaceutical manufacturers' due process rights by compelling participation and imposing severe financial penalties without meaningful judicial review

No question identified. : 2. Absent an extension, a petition for a writ of certiorari would be due on August 6, 2025. This application is being filed more than ten days before that date, and no prior application has been made in this case. 3. AstraZeneca is a world-leading pharmaceutical company that creates medicines to treat serious diseases. AstraZeneca aims to provide patients with access to its medications today, and to continue funding innovative, life-saving medical advancements for tomorrow. That life-saving and innovative work requires tremendous investment: AstraZeneca spends billions on research and development, and any given drug can take years to develop before it is approved—if it is approved at all. As a result of that investment and those attendant risks, AstraZeneca has received numerous patents that protect its innovations. Those patents, alongside regulatory exclusivity periods, allow AstraZeneca to recoup its investments based on the prevailing market-dictated price. Rigorous enforcement of patent rights and the ability to sell drugs at market prices is essential to the continued investment necessary to develop and market new drug products. 4, The government has upended this regime. In the Inflation Reduction Act of 2022 (IRA), Congress implemented the so-called “Drug Price Negotiation Program,” a Medicare price-fixing regime that forces manufacturers like AstraZeneca to sell their patented drugs at government-dictated prices. See 42 U.S.C. § 1820f et seg. Under the Program, the Centers for Medicare & Medicaid Services (CMS) must identify and select a designated number of drugs each year for which to “negotiate” a price cap for prescription drugs dispensed to Medicare-eligible individuals. See id. § 1320f-1. Nothing about this “negotiation” mirrors a typical commercial negotiation over a product’s sales price. For starters, negotiation is mandatory: Manufacturers must sign an agreement by a date certain to participate in the negotiation process. See id. § 13820f-2. In addition, although the Program nominally allows CMS and the manufacturer to jointly determine the negotiated price, the statute directs CMS to “achieve the lowest maximum fair price for each selected drug.” Id. § 1320f-3(b)(1). 5. Manufacturers that do not wish to participate in the Program are out of luck. Refusing to negotiate with CMS or to agree to CM&’s offered price triggers a daily penalty beginning at 185% of the drug’s price and quickly escalating to 1,900%. See Cong. Rsch. Serv., No. R47202, Tax Provisions in the Inflation Reduction Act of 2022 (H.R. 5376), at 4 thl. 2 (Aug. 10, 2022); 26 U.S.C. § 5000D(a)-(b). There are only two ways to “suspen[d]” this oppressive penalty: A manufacturer can acquiesce to CMS’s price or it can terminate “all applicable agreements” to sell every single one of its eligible drugs as part of Medicare and Medicaid, which would leave huge swaths of the country without access to any of the manufacturer’s medications. 26 U.S.C. § 5000D(c). 6. To make matters worse, the IRA deprives manufacturers of any procedural protections. CMS need not go through notice-and-comment rulemaking, and there is no process for manufacturers to ask CMS to reconsider its decision to select a manufacturer’s drug for “negotiation” under the Program or the price cap CMS has set. The IRA also expressly precludes “administrative or judicial review” of CMS8’s decision to select certain drugs for negotiation and CM9’s offer price. 42 U.S.C. § 1320f-7. 7. AstraZeneca, which manufactures a drug that has been selected for price regulation under this regime, challenged the Program as violating AstraZeneca’s due process rights. AstraZeneca explained that the Program deprives AstraZeneca of its investment-backed patent rights and the right to sell its drug at market prices, without providing even the most rudimentary procedural safeguards. 8. The district court rejected AstraZeneca’s claim. In its view, because participation in Medicare is