A 340B administrative dispute resolution (ADR) panel decided late last week that it will not stop proceedings in the National Association of Community Health Centers’ (NACHC) dispute-resolution petition over drug manufacturers AstraZeneca and Sanofi’s conditions on 340B pricing when covered entities use contract pharmacies. It gave the companies until March 13 to respond to NACHC’s January 2021 complaints.
The ADR panel reached its decision on Feb. 11. “Until Congress changes the law, a court of competent jurisdiction enjoins either the ADR rule or this panel’s activities, or HHS [the U.S. Health and Human Services Department] amends or replaces the ADR rule, this panel must assume it has a mandate to hear the petitions before it,” the panel said. “Accordingly, and for the reasons set forth above, the motions for a stay are denied.”
AstraZeneca yesterday told outgoing U.S. District Judge Leonard Stark of the District of Delaware in a letter that it “continues to believe that an expeditious resolution of this matter is appropriate, and indeed, necessary” in view of Astra’s still-undecided lawsuit over the federal government’s May 2021 finding that Astra’s 340B contract pharmacy policy violates the 340B statute.
AstraZeneca also has cited the forthcoming publication of a replacement 340B ADR regulation as another reason to stay NACHC’s ADR petition against it. HHS had said that the replacement rule would be published for review and comment last month but it remains under White House review.
Stark heard arguments in AstraZeneca’s 340B contract pharmacy case last October but hasn’t handed down his ruling.
Stark Headed to Washington, D.C
The U.S. Senate voted 61-35 on Feb. 9 to approve Stark’s nomination to serve on the U.S. Court of Appeals for the Federal Circuit, a special court in Washington, D.C., that mainly handles patent case appeals.
Stark handed down three opinions in other cases this morning, so it is possible he could still decide AstraZeneca’s 340B contract pharmacy case before he is sworn in to serve on the appeals court.
NACHC’s original ADR petition named three manufacturers—Astra, Sanofi, and Lilly. In March 2021, a federal district judge enjoined HRSA from implementing or enforcing its 340B ADR regulations against Lilly. In September 2021, NACHC split its ADR petition into two—one against Lilly alone, the other against Sanofi and AstraZeneca together—to let proceedings against Sanofi and AstraZeneca go forward.
Pharmaceutical Research and Manufacturers of America (PhRMA) has sued in federal district court in Baltimore to have the 340B ADR final rule declared illegal and unconstitutional. The last brief in that case was filed in October 2021 and a decision is pending.