Does the Medicare Drug Price Negotiation Program violate the First Amendment by compelling pharmaceutical companies to express the government's disputed messages regarding drug pricing, and does it effect a Fifth Amendment taking by forcing drug manufacturers to transfer products on government terms?

The “Medicare Drug Pric e Negotiation Program,” enacted in 2022, imposes new requirements for certain widely prescribed drugs. Under the Program, manufacturers must provide Medicare beneficiaries “access” to covered drugs at below-market prices set by the Centers for Medicare and Medicaid Services (“CMS”) and sign “agreement[s]” describing those prices as “negotiate[d]” “maximum fair price[s]” for their drugs. 42 U.S.C. § 1320f-2(a). Manufacturers that do not comply with these requirements are subject to tens of billions in annual excise taxes or exclusion from Medicare and Medicaid, which together account for nearly half the U.S. drug market. Petitioner Janssen Pharmaceuticals Inc. markets Xarelto ®, a drug selected by CMS for the Program. Janssen alleged that the Program unlawfully compels the company’s speech and effects a per se taking of the company’s property. The Third Circuit rejected those claims, holding that the Program is lawful because participation is “voluntary.” Judge Hardiman dissented, concluding that the Program’s penalties unconstitutionally “force” Janssen “to turn over” its pr oducts on terms “set by CMS” and “misrepresent” that it “negotiated” a “fair” price for Xarelto ®. The questions presented are: 1. Does the Program violate the First Amendment by compelling Janssen to express the Government’s disputed messages regarding drug pricing? 2. Does the Program effect a Fifth Amendment taking by forcing Janssen to transfer its Xarelto® ii products to third parties on the Government’s terms? 3. Is the Program immune from constitutional scrutiny because it secures compliance through economic coercion?