Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick summary of relevant updates from the prior week in this industry-shaping body of litigation. 

Issues at Stake: HRSA Audit Process; Rebate Model; Other

• In a case brought by a 340B covered entity against the Health Resources and Services Administration (HRSA) alleging that HRSA prevented the covered entity from accessing the 340B Program, the covered entity filed a notice of voluntary dismissal.
• In a case challenging HRSA’s policy prohibiting all manufacturer conditions on 340B transactions, plaintiffs filed a motion for summary judgment.
• In a Freedom of Information Act (FOIA) case, the plaintiff filed a motion to strike HRSA’s motion for summary judgment.
• In one HRSA audit process case, the plaintiff filed a brief in opposition to a drug manufacturer’s motion for leave to file as amicus curiae.
• In four HRSA audit process cases, the parties filed joint stipulations that the government will provide to the plaintiffs thirty days’ written notice before termination of the plaintiffs from the 340B Program.
• In five cases against HRSA alleging that HRSA unlawfully refused to approve drug manufacturers’ proposed rebate models:
  • In two cases, each drug manufacturer plaintiff filed a motion for summary judgment and a group of interested parties filed a motion to intervene.
  • In one case, two patient advocacy groups filed a motion for leave to file as amicus curiae.
  • In one case, the drug manufacturer plaintiff filed a motion for summary judgment, a group of interested parties filed a motion to intervene, and two patient advocacy groups filed a motion for leave to file as amicus curiae.
  • In one case, a group of interested parties filed a motion to intervene.

Kelsey Reinhardt and Nadine Tejadilla also contributed to this article.