Pharmaceutical Research and Manufacturers of America told a federal district judge last week that the federal government has failed to refute PhRMA’s contention that the regulation establishing the 340B administrative dispute resolution (ADR) process “is unconstitutional, procedurally defective, and relies on audit guidelines that are inconsistent with the 340B statute.”
The drug industry trade association sued in federal district court in Baltimore, Md., in January to strike down both the 340B ADR rule and guidelines governing drug manufacturer audits of 340B covered entities. PhRMA’s Oct. 12 court filing was in response to the government’s Sept. 9 brief making its case why the ADR rule is constitutional and why the 340B audit guidelines are legal.
Pharmaceutical Research and Manufacturers of America told a federal district judge last week that the federal government has failed to refute PhRMA’s contention that the regulation establishing the 340B administrative dispute resolution (ADR) process “is unconstitutional, procedurally defective, and relies on audit guidelines that are inconsistent with the 340B statute.”
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