Pharmaceutical Research and Mfrs. of America v. Walsh, 538 U.S. 644, 15 (2003)

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658

PHARMACEUTICAL RESEARCH AND MFRS. OF AMERICA v. WALSH

Opinion of the Court

"3 to 6 times as expensive" as amoxicillin.25 Concannon's affidavit described the composition of a committee of physicians and pharmacists that would "make the final determination of the clinical appropriateness of any recommendation that a prior authorization requirement be imposed with respect to a particular prescription drug manufactured by a manufacturer which has not entered into a Maine Rx Rebate Agreement." 26

Without resolving any factual issues, the District Court granted petitioner's motion for a preliminary injunction. Relying on Healy v. Beer Institute, 491 U. S. 324, 336 (1989), the court first held that Maine had no power to regulate the prices paid to drug manufacturers in transactions that occur out of the State. Recognizing that some of their sales were made to two distributors in Maine, the court further held that the Medicaid Act pre-empted Maine's Rx Program insofar as it threatened to impose a prior authorization requirement on nonparticipating manufacturers. In so holding, the court assumed for the purpose of the decision that the " 'Department of Human Services will not deny a single Medicaid recipient access to the safest and most efficacious prescription drug therapy indicated for their individual medical circumstances.' " 27 In that court's view, pre-emption was nevertheless required because "Maine can point to no Medicaid purpose in this new prior authorization requirement that Maine has added for Medicaid prescription drugs. Maine has not just passed a law that might conflict with the objectives of a federal law. It has actually taken the federal Medicaid program and altered it to serve Maine's local purposes." 28 In the District Court's view, the fact that the

25 Id., at 154.

26 Id., at 167.

27 Civ. No. 00-157-B-H (D. Me., Oct. 26, 2000), App. to Pet. for Cert. 68.

28 Ibid. The court further observed: "If Maine can use its authority over Medicaid authorization to leverage drug manufacturer rebates for the benefit of uninsured citizens, then it can just as easily put the rebates into

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