The federal government has asked a judge to dismiss PhRMA's legal challenge to the 340B administrative dispute resolution final rule and guidelines governing drug manufacturer audits of 340B covered entities.

DOJ Asks Judge to Toss PhRMA Suit Against 340B Dispute Resolution System and Audit Guidelines

The U.S. Justice Department (DOJ) has submitted a blistering motion asking that a lawsuit filed by Pharmaceutical Research and Manufacturers of America (PhRMA) to strike down the new 340B program administrative dispute resolution (ADR) process be tossed out of court.

Filed on June 11, the motion accused PhRMA of a “brazen strategy” to upend the entire 340B program. “PhRMA’s ultimate goal in this suit is manifestly clear in its complaint: It seeks to interfere with HHS’s enforcement of the 340B statute against its members,” DOJ attorneys declared.

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