Brand drug manufacturers have asked a federal appeals court to overturn a judge’s ruling last month 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.
Pharmaceutical Research and Manufacturers of America on Dec. 30 filed its notice of appeal to the U.S. Eighth Circuit Court of Appeals in St. Louis, Missouri. Its opening brief is due Feb. 8. The state’s response is due on or about March 10.
Arkansas passed a law, Act 1103, in May 2021 that says manufacturers (1) may not prohibit pharmacies from contracting with 340B covered entities by denying access to the drugs they make and (2) may not deny 340B pricing “for an Arkansas-based community pharmacy” that receives 340B-purchased drugs under a 340B contract pharmacy arrangement. The state insurance department published implementing regulations in September 2022.
PhRMA sued the state the year before. It said that, under the U.S. Constitution’s Supremacy Clause, Act 1103 was preempted by both the federal 340B statute and the federal Food, Drug, and Cosmetics Act. It also argued that Act 1103 is invalid under the constitution’s Commerce Clause, in that it impermissably regulates business occurring wholly outside the state’s boundaries.
PhRMA, the state, and Arkansas covered entities that were allowed to participate in the case agreed to focus court proceedings first on PhRMA’s federal preemption argument. U.S. Senior District Judge Billy Roy Wilson ruled against PhRMA on Dec. 12.
Late last month, Wilson and parties to the case agreed to (1) stay the Commerce Clause portion of PhRMA’s case pending a forthcoming U.S. Supreme Court decision about the clause and (2) finalize Wilson’s ruling in the Supremacy Clause portion. Wilson’s Dec. 29 final judgement and order dismissing PhRMA’s federal preemption claim cleared the way for PhRMA to take that claim the next day to the Eighth Circuit Court.
