HIV/AIDS clinics' and community health centers' lawsuits to force HHS to act against drug manufacturers denying 340B pricing are both being heard in federal district court in Washington, D.C.

Federal Judge To Get Status Report Today from Ryan White Clinics and Government

Ryan White Clinics for 340B Access (RWC-340B) and the federal government have a deadline today to report to a federal judge about whether to continue the stay in the group’s suit to force the government to act against drug manufacturers denying 340B pricing on drugs dispensed by contract pharmacies.

RWC-340B sued the U.S. Health and Human Services Department (HHS) last October, in part, to force it to issue final 340B administrative dispute resolution (ADR) regulations, which the government did in December. In January, U.S. District Judge Ketanji Brown Jackson for the District of Columbia granted the two sides’ joint request for a stay in proceedings to let an ADR petition RWC-340B filed on behalf of its members to go forward.

In a Feb. 16 status report, the two sides agreed “that they should file a further joint status report on the earlier of April 19, 2021, or within five business days of the entry of any injunction of the ADR Rule.” Today marks the fifth business day since a federal judge in Indiana granted Lilly’s motion for such an injunction. The joint report is expected to address the Lilly injunction.

If the government and RWC-340B cannot agree what to say in the report, the two sides will file separate reports. RWC-340B and other 340B provider groups have been increasingly frustrated by the slow pace of the ADR process.  In his last day in office, President Trump’s HHS Secretary Alex Azar appointed the ADR board members. The Biden administration quickly withdrew Azar’s notice as well as other last minute Trump administration regulations and pronouncements.

Jackson also is the judge assigned to the National Association of Community Health Centers’ similar suit against HHS, which also was stayed to let NACHC’s ADR petitions on behalf of its members against Lilly, Sanofi, and AstraZeneca to proceed. On Friday, Jackson ordered both sides to submit a new joint status report on or before April 19.

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