Eighth Circuit Denies Novartis Injunction, Upholds Missouri Law Mandating Unlimited 340B Contract Pharmacy Access
核心洞察
A unanimous Eighth Circuit panel rejected Novartis' bid to block Missouri's SB 751, which requires drugmakers to provide unlimited 340B-discounted drug access to contract pharmacies.
The court found the law does not violate the dormant commerce clause, as it regulates only in-state delivery of 340B drugs rather than out-of-state transactions.
Novartis argued the law unconstitutionally controls prices outside Missouri, but the panel distinguished this case from a prior Eighth Circuit ruling on Minnesota's generic drug pricing law.
A unanimous three-judge panel of the U.S. Court of Appeals for the Eighth Circuit on Wednesday denied Novartis Pharmaceuticals' request for a preliminary injunction to block Missouri's Senate Bill 751, a state law requiring drug manufacturers to provide medical providers with unlimited access to discounted drugs through the federal 340B Drug Pricing Program (搜索).
The ruling, authored by U.S. Circuit Judge Ralph R. Erickson and joined by Circuit Judges Lavenski R. Smith and Duane Benton, affirmed a lower court decision that Novartis was unlikely to succeed on the merits of its constitutional challenge.
The Law at Issue
Senate Bill 751, which took effect in 2024, requires drugmakers to accept orders from providers eligible for discounts under the 340B program, a federal initiative designed to serve low-income and uninsured patients by offering more comprehensive medical services. Critically, the Missouri law allows these covered entities to maintain an unlimited number of contracts with pharmacies for dispensing 340B drugs.
Manufacturers must participate in the 340B Program and its price controls as a condition for having Medicare Part B and Medicaid pay for their therapies.
Novartis' Constitutional Challenge Falls Short
Novartis sued Missouri Attorney General Andrew Bailey and members of the state's pharmaceutical board in 2024, shortly after the rules were signed into law, claiming the statute violates both the dormant commerce clause and the supremacy clause of the U.S. Constitution. U.S. District Judge M. Douglas Harpool originally denied Novartis' request for an injunction, prompting the appeal.
During a January hearing before the Eighth Circuit panel, Novartis attorney Jessica L. Ellsworth of Hogan Lovells US LLP cited the court's 2025 decision in Association for Accessible Medicines v. Ellison, which struck down a Minnesota law prohibiting manufacturers from imposing excessive price increases on generic or off-patent drugs. In that case, the Eighth Circuit found the Minnesota law had the impermissible effect of controlling prices outside the state.
The panel, however, found that precedent inapplicable to the Missouri challenge.
"While S.B. 751 may incidentally bear on out-of-state transactions, it does not have a specific impermissible extraterritorial effect and directly regulates only the delivery of 340B drugs to covered entities and their contract pharmacies," Erickson wrote. "Because S.B. 751 is consistent with Missouri's power to regulate conduct occurring within its borders, Novartis is not likely to prevail on the merits of its extraterritoriality challenge."
No Discriminatory Effect on Interstate Commerce
The court was equally unpersuaded by Novartis' argument that the law discriminates against interstate commerce in violation of the dormant commerce clause.
"S.B. 751 does not facially discriminate against interstate commerce because it does not refer to in-state or out-of-state manufacturers or otherwise indicate a preference for in-state entities," Erickson wrote.
The panel further noted that once covered entities purchase 340B drugs at the ceiling price set by federal law, SB 751 merely prevents drug manufacturers from prohibiting those entities from directing delivery to their contract pharmacies. "Novartis fails to show how such a policy discriminates against out-of-state economic interests or affects the price of 340B drugs," the opinion stated.
Broader Implications
The decision represents another legal victory for proponents of expanded 340B program access, as pharmaceutical manufacturers have increasingly sought to limit the number of contract pharmacies through which covered entities can dispense discounted drugs. Neither Ellsworth nor the Missouri Attorney General's office immediately responded to requests for comment following the ruling.