Two items today, both 340B. Thirteen drug manufacturers moved Arkansas’ contract pharmacy lawsuit out of state court and into federal court, and a Senate committee took up an HHS nominee who has published work critical of the 340B program. Nothing from the California Board of Pharmacy, and no pharmacy enforcement actions in this week’s federal bulletins.
Drug manufacturers move Arkansas’ 340B contract pharmacy case into federal court
Arkansas was the first state to pass a law requiring drug manufacturers to honor 340B pricing at contract pharmacies, and roughly a dozen states have since passed their own versions. Thirteen manufacturers have now moved the state’s lawsuit against them from state court into federal court. A removal is a decision about which courthouse hears the case, not a ruling on whether the Arkansas law stands, and the grounds the manufacturers actually assert cannot be characterized before the filings are read. The reason to follow it is that these state access laws are the main pressure point on contract pharmacy arrangements right now, and where they are decided will shape how quickly other states act. California has no statute compelling manufacturers to ship. What California pharmacies do have is Business and Professions Code section 4126, which allows a covered entity to contract with a pharmacy for 340B dispensing and then places two standing duties on the pharmacy: 340B stock must be separated from other drug stock by physical or electronic means, and records of acquisition and disposition must be retrievable separately from the pharmacy’s other records. The contract itself is available for inspection by Board staff during normal business hours. Read more at 340B Report →
A Senate committee reviews an HHS nominee who has criticized 340B
The Senate Finance Committee took up the nomination of a Johns Hopkins professor for an assistant secretary post at HHS. The nominee has authored studies critical of the 340B program. A confirmation hearing changes nothing on its own, and it is early to read policy into it. For covered entities and the pharmacies that contract with them, it is worth knowing who may end up in the role. Read more at 340B Report →
This update is general information about developments in pharmacy law and regulation. It is not legal advice, it does not create an attorney-client relationship, and it should not be relied on as a substitute for advice about your own situation. Prior results do not guarantee a similar outcome. If you have a specific question about your pharmacy, call or write and we will talk about it properly.
Law Office of Bhavesh Desai | Bhavesh Desai, Pharm.D., Esq.
Yorba Linda, CA 92886 | (909) 618-7299