A federal judge has struck down North Dakota’s 340B drug pricing law, ruling it unconstitutional and permanently blocking its enforcement.
U.S. District Judge Daniel Traynor found the law violated both the Supremacy Clause and the Commerce Clause by interfering with a federal drug pricing program, according to an April 27 court order. The ruling granted summary judgment in part to AbbVie and industry trade group Pharmaceutical Research and Manufacturers of America.
The law, H.B. 1473, restricted drug manufacturers participating in the federal 340B program, including limits on contract pharmacy arrangements and data requirements. The court found the statute improperly regulated manufacturer participation in a program enacted under Congress’ spending power and had an impermissible effect on interstate commerce by influencing transactions between out-of-state manufacturers and wholesalers.
The decision permanently enjoins North Dakota from enforcing the law against the plaintiffs and PhRMA members.
AbbVie, AstraZeneca and PhRMA filed federal lawsuits against the law in August 2025, arguing it infringed on federal authority and violated the Fifth Amendment.
The ruling deepens a growing split among federal courts over whether states can regulate manufacturer participation in the 340B program. The 4th U.S. Circuit Court of Appeals in March upheld a block on a similar West Virginia law, marking the first federal appeals court win for drugmakers on state 340B laws.
But courts elsewhere have reached the opposite conclusion: the U.S. Supreme Court rejected a challenge to Arkansas’ 340B law in December 2024, the 5th Circuit Court of Appeals upheld Mississippi’s 340B protections, and federal courts in Hawaii and Colorado denied manufacturer efforts to block similar state laws.
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