Drug manufacturer AstraZeneca and two health centers aligned with Ryan White Clinics for 340B Access (RWC-340B) briefed a 340B administrative dispute resolution (ADR) panel last week on whether a recent federal court ruling has implications for the health centers’ 340B contract pharmacy-related complaints against the company.
Astra in January asked the ADR panel to stay proceedings against it pending the outcome of its case challenging the federal government’s May 2021 determination that Astra’s conditions on 340B pricing when covered entities use contract pharmacies is illegal. Astra also said the panel should stay the proceedings given that the government has said it will publish new 340B ADR regulations.
Federal District Judge Leonard Stark of the District of Delaware ruled on Feb. 16 that the U.S. Health Resources and Services Administration (HRSA) did not comply with the federal Administrative Procedure Act when it issued its 340B program violation letter to Astra.
After Stark’s ruling, the 340B ADR panel ordered Astra and two health centers that filed the petition against it—Little Rivers Health Care in Vermont and FamilyCare Health Center in West Virginia—to file supplemental briefs addressing whether Stark’s decision should influence its decision on whether to grant Astra’s motion for an indefinite stay. The two sides filed those briefs on March 2.
What the two sides argued in their briefs last week isn’t known. The U.S. Health Resources and Services Administration (HRSA) does not make the docket in 340B ADR proceedings accessible to the public.
The disclosure about the ADR panel’s order for the supplemental briefs came in a March 4 joint status report in RWC-340B’s lawsuit against HRSA to compel the agency to publish long-delayed 340B ADR regulations, which HRSA ultimately did in December 2020.
These status reports, and similar ones in the National Association of Community Health Centers’ companion lawsuit against HRSA, include details from time to time about what is happening in Little Rivers and FamilyCare’s ADR petition against Astra and in NACHC’s two ADR petitions against, one against Lilly and the other against Astra and Sanofi.
There is a federal district court injunction against ADR proceedings against Lilly.
Last month, a 340B ADR panel denied Astra and Sanofi’s motion for a stay in the proceedings that NACHC brought against them. The panel, however, denied the stay the day before Judge Stark ruled in Astra’s favor in its lawsuit against HRSA.