Astra USA, Inc., et al., Petitioners v. Santa Clara County, California (563 U.S. 110)
U.S. Supreme Court · decided March 29, 2011 · Supreme Court Database (Spaeth)
- Citation
- 563 U.S. 110 · 131 S. Ct. 1342
- Decided
- March 29, 2011
- Term
- October Term 2010
- Vote
- 8–0
- Majority author
- Justice Ginsburg
- Issue area
- Judicial Power
- Disposition
- Reversed
- Outcome
- Petitioning party won
- Ideological direction
- Conservative
Opinion excerpt
Justice Ginsburg delivered the opinion of the Court. Section 340B of the Public Health Services Act, 42 U. S. C. §256b (2006 ed. and Supp. IV), imposes ceilings on prices drug manufacturers may charge for medications sold to specified health-care facilities. Those facilities, here called “340B” or “covered” entities, include public hospitals and community health centers, many of them providers of safety-net services to the poor. The §340B ceiling-price program (340B Program) is superintended by the Health Resources and Services Administration (HRSA), a unit of the Department of Health and Human Services (HHS). Drug manufacturers opt into the 340B Program by signing a form Pharmaceutical Pricing Agreement (PPA) used nationwide. PPAs are not transactional, bargained-for contracts. They are uniform agreements that recite the responsibilities § 340B imposes, respectively, on drug manufacturers and the Secretary of HHS. Manufacturers’ eligibility to participate in State Medicaid programs is conditioned on their entry into PPAs for covered drugs purchased by 340B entities. It is conceded that Congress authorized no private right of action under §340B for covered entities who claim they have been charged prices exceeding the statutory ceiling. This case presents the question whether 340B entities, though accorded no right to sue for overcharges under the statute itself, may…
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