Ryan White Clinics for 340B Access told a federal district judge last week it needs time to assess how proposed new 340B administrative dispute resolution regulations, if finalized, could affect the 340B overcharging claims it brought against AstraZeneca under the current ADR process and its related lawsuit that helped pressure the federal government to implement that process.
RWC-340B and the federal government submitted a status report on Dec. 1 in federal district court in Washington, D.C., in the group’s ongoing lawsuit. The advocacy group’s suit, which was filed in October 2020, helped force the government to issue and implement the existing ADR rules.
RWC-340B and two affiliated community health centers filed an ADR petition against AstraZeneca in January 2021 over the company’s policy of recognizing just one contract pharmacy per covered entity and only for those without an in-house pharmacy. RWC-340B’s lawsuit has been stayed while it pursues its claims in the ADR process.
The government on Nov. 30 published a long-awaited proposed rule that would replace the existing ADR process with one it says would be “more accessible” and less “trial-like.” According to the Dec. 1 status report in the court case, the government also on Nov. 30 told RWC-340B and its co-plaintiffs it thinks that their lawsuit should be dismissed as moot in light of the government’s proposal to replace the ADR process.
If the proposed rule is finalized, any existing claims filed under the old ADR system would be automatically transferred to the new system.
Also, if a claim before an ADR panel is the same as or similar to one before a federal court, the panel “will suspend review of the claim until such time the issue is no longer pending in federal court,” the proposed rule says.
RWC-340B and its co-plaintiffs said in the status report they told the government they need more time to assess the impact the Nov. 30 proposed rule may have on the case.
They and the government jointly agreed and asked the court for permission, which the court granted, to file another status report on Jan. 17.
Last week, the National Association of Community Health Centers dismissed its companion lawsuit against the government. In August, the ADR panel assigned to consider NACHC’s petition against Astra Zeneca and Sanofi dismissed it on the grounds that it raised questions identical to those being litigated in federal courts in Astra Zeneca and Sanofi’s lawsuits defending the legality of their 340B contract pharmacy policies.
