Drug manufacturers AstraZeneca and Sanofi have asked 340B administrative dispute resolution panels to pause covered entities’ ADR proceedings against them until all 340B-related federal court litigation is finished and until after the government finalizes its forthcoming new 340B ADR regulation.
The National Association of Community Health Centers (NACHC) is opposing any further delay of its ADR petitions against AstraZeneca and Sanofi. Ryan White Clinics for 340B Access (RWC-340B), which has brought ADR claims against AstraZeneca only, likewise is opposing that company’s requests for an indefinite stay.
AstraZeneca and Sanofi’s requests for the ADR stays came to light late yesterday in status reports in NACHC and RWC-340B’s lawsuits against the government in 2020 to force it to publish long-delayed 340B ADR regulations, which the government did in December 2020.
Rare Peek at the ADR Process
The U.S. Health Resources and Services Administration (HRSA) does not make 340B ADR proceedings and documents public. The periodic status reports in NACHC and RWC-340B’s lawsuits give outsiders a rare peek at the process.
NACHC filed ADR petitions in January 2021 against AstraZeneca, Sanofi, and Lilly over their denials of 340B pricing when covered entities use contract pharmacies. RWC-340B filed a petition that same month against AstraZeneca only. A federal judge last March granted Lilly’s motion for an injunction against any ADR proceedings against it. Last October, NACHC broke its ADR petition into two—one against Lilly, and the other against AstraZeneca and Sanofi. That same month, a federal judge denied Sanofi’s motion for a stay against ADR proceedings.
After multiple false starts, ADR proceedings against AstraZeneca and Sanofi began in late October.
According to the two status reports submitted yesterday to Judge Florence Pan of the U.S. District Court for the District of Columbia, AstraZeneca and Sanofi both took advantage of one-time 30-day extensions of deadlines built into the ADR system.
According to the status report in RWC-340B’s lawsuit, yesterday “AstraZeneca filed motions with the ADR panel requesting indefinite stays of the ADR proceedings pending the outcome of the 340B-related district court litigation…and the conclusion of any further rulemaking proceeding by HHS.”
According to the status report in NACHC’s lawsuit, on Dec. 20 “Sanofi and AstraZeneca each filed motions to stay the ADR process pending resolution of their—and the other— federal court cases challenging the government’s authority to enforce 340B program requirements, including all available appeals, and completion of rulemaking related to the proposed new ADR rule.”
The Biden administration disclosed on Dec. 10 that it plans to replace the Trump administration 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.” It said it expected to publish a new 340B ADR proposed rule for notice and comment this month.