Pharmaceutical Research & Manufacturers of America v. John McCuskey
Split Score
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Case Summary
Disposition
Affirmed
The Fourth Circuit upheld a preliminary injunction blocking enforcement of West Virginia’s S.B. 325, a law that forces drug manufacturers in the federal 340B program to supply discounted drugs to any contract pharmacy used by a covered entity. The court ruled that the statute is likely pre-empted because it impermissibly alters Congress’s 340B bargain and intrudes into a field reserved for federal regulation, satisfying the Winter factors for injunctive relief.
Circuit Split Identified
Legal Issue
Whether state statutes that compel drug manufacturers participating in the federal 340B program to deliver discounted drugs to an unlimited number of contract pharmacies are pre-empted by 42 U.S.C. § 256b under the Supremacy Clause.
Circuit Positions
State laws mandating delivery of 340B drugs to contract pharmacies are pre-empted by federal law.
State laws regulating delivery of 340B drugs are not pre-empted because § 340B is silent on delivery and does not occupy the field.
Conflict Summary
The Fourth Circuit holds that § 340B occupies the field and/or conflicts with state attempts to add delivery obligations, so such statutes are pre-empted. The Fifth and Eighth Circuits conclude that § 340B is silent on delivery, leaving room for state regulation; therefore the same kinds of state laws are not pre-empted.