A federal district judge ruled yesterday that Arkansas’s novel 340B anti-discrimination law is not preempted by the 340B statute nor by the U.S. Food and Drug Administration’s Risk Evaluation and Mitigation Strategies requirements.
U.S. Senior District Judge Billy Roy Wilson’s Dec. 12 opinion is a setback for Pharmaceutical Research and Manufacturers of America, which sued to have the law declared illegal and unconstitutional. Proceedings in the case will now turn to PhRMA’s arguments that the state law violates the federal constitution’s Commerce Clause.
Wilson said he is not convinced that the 340B program is “a solely federal scheme immune from any type of state regulation.”
The state law, Act 1103, says a drug manufacturer shall not deny a pharmacy contracting with a 340B covered entity access to the manufacturer’s drugs nor deny such a pharmacy access to 340B pricing.
We will report more about the ruling on Thursday.