Powers attorney Barbara Williams was quoted in a Bloomberg article this week about the harms caused by the delay in establishing a drug pricing 340B alternative dispute resolution (ADR) board, a long-awaited step in finalizing the ADR process.
The article discusses the Department of Health and Human Services’ (HHS) failure to set up an ADR board, which would enable 340B covered entities to challenge manufacturer actions that are not in compliance with 340B program requirements, including the requirement to offer 340B pricing at contract pharmacies. Former HHS Secretary Alex Azar selected individuals to serve on the board during the final days of the Trump administration, but the picks were withdrawn by the Biden administration. Until the ADR process is in place, hospitals, Ryan White Clinics, community health centers, and other 340B covered entities are stalled in their efforts to force manufactures to provide 340B pricing at contract pharmacies.
Barbara, along with other Powers 340B attorneys, represents RWC-340B and several 340B covered entities in their lawsuit against HHS over the refusal of several drug companies to provide 340B discounts at contract pharmacies. Barbara discussed the need for immediate relief for those clinics who rely on drug discounts to serve low-income patients. In the article, Barbara is quoted as saying, “We thought they were going to get this relief. We can’t just leave this to languish. There are a lot of covered entities that this is hitting very hard.” Barbara also said, “We hope we don’t have to revive our lawsuit,” which was stayed in early 2021 after the Trump administration published a final rule to implement the ADR process with the belief that the covered entities would be able to bring their claims in that venue.