AbbVie, Inc. and other pharmaceutical manufacturers sued to block the state statute, arguing it was preempted by federal law. The district court had ruled the plaintiffs were unlikely to succeed on the merits.
The state law, H.B. 1056, prohibits a 340B manufacturer from limiting the distribution of a 340B drug to a pharmacy under contract with a covered entity, unless federal law requires it. The statute defines key terms by reference to 42 U.S.C. § 256b.
The Fourth Circuit held that the district court erred as a matter of law. The court relied on its recent decision in PhRMA, which held that a materially similar West Virginia statute was likely preempted.
The court noted that the Maryland law imposes obligations on drug manufacturers solely by virtue of their participation in the federal 340B program and does not regulate manufacturers outside that program.
The Fourth Circuit vacated the district court’s order and remanded the case. It left it to the district court to determine the propriety of preliminary relief in the first instance, applying the principles set forth in PhRMA.