A Vermont community health center that co-initiated 340B administrative dispute resolution (ADR) proceedings against AstraZeneca over its conditions on 340B contract pharmacy yesterday asked the panel hearing its claim to deny the drug company’s motion to stay the proceedings.
Little Rivers Health Care, together with Open Door Community Health Centers in California, FamilyCare Health Center in West Virginia, and Ryan White Clinics for 340B Access (RWC-340B), filed the ADR petition against AstraZeneca in January 2021. They want the panel to declare that Astra’s policy of letting covered entities buy its drugs at the 340B price only through just one on-site dispensing pharmacy or through just one designated contract pharmacy violates the 340B statute.
Astra is suing the U.S. Health and Human Services Department (HHS) over its May 2021 finding that the company’s conditions on 340B pricing policy are illegal and must stop. HHS told Astra that entities are entitled to refunds for overcharges and if the company does not comply, it could face civil monetary penalties.
Pharmaceutical Research and Manufacturers of America (PhRMA) meanwhile is suing HHS and its Health Resources and Services Administration (HRSA) over the legality and constitutionality of HRSA’s 340B ADR regulations.
HRSA meanwhile disclosed on Dec. 10 that it will replace its 340B ADR regulation with an entirely new rule that “better aligns with the president’s priorities on drug pricing [and] better reflects the current state of the 340B program.”
New ADR Rule Expected Any Day Now
HRSA is expected to publish its new 340B ADR proposed rule for notice and comment any day now. It might unveil the proposed rule during next week’s 340B Coalition winter conference.
According to Little Rivers’ filing yesterday in its ADR proceeding, Astra on Jan. 3 moved to stay the proceedings pending the outcomes of (1) its 340B contract pharmacy lawsuit against HHS and HRSA, (2) PhRMA’s lawsuit against the government over the current ADR regulations, and (3) finalization of the new ADR regulation that HHS and HRSA say is forthcoming.
“The ADR panel should deny the stay requested by AstraZeneca,” Little Rivers told the panel yesterday. “The harms that will be incurred by Little Rivers in granting a stay far outweigh any of the harms conjectured by AstraZeneca to support a stay and there is no guarantee that a stay would promote efficiency. The mere prospect that federal court proceedings or administrative actions could impact the current ADR proceedings does not overcome the significant harm caused by AstraZeneca’s unchecked denial of lawful 340B discounts, and AstraZeneca has not shown that it will suffer any significant injury if this proceeding, pending for almost one year, moves forward.”
“The ADR panel should deny the motion to stay and direct AstraZeneca to respond substantively to Little Rivers’ petition so that the ADR panel can resolve the longstanding claims at issue,” the health center said.
