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BREAKING: PhRMA Asks Court to Strike Down 340B Dispute Resolution Rule and Manufacturer Audit Guidelines

Pharmaceutical Research and Manufacturers of America (PhRMA) sued yesterday in federal district court in Maryland to strike down the federal final rule that established the new 340B program administrative dispute resolution (ADR) process. It also wants the court to declare federal 340B program guidelines governing drug manufacturer audits of 340B covered entities illegal.

“The Trump Administration rushed to finalize a flawed ADR rule and ignored the program’s larger issues,” PhRMA Executive Vice President and General Counsel James C. Stansel said Friday.

Pharmaceutical Research and Manufacturers of America (PhRMA) sued yesterday in federal district court in Maryland to strike down the federal final rule that established the new 340B program administrative dispute resolution (ADR) process. It also wants the court to declare federal 340B program guidelines governing drug manufacturer audits of 340B covered entities illegal.

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