Regulations establishing a binding administrative dispute resolution (ADR) process for the 340B program were rushed into place last December to defeat lawsuits, are fatally flawed legally and constitutionally, and should be struck down, the main U.S. trade association for drug manufacturers told a federal judge late last month.
Pharmaceutical Research and Manufacturers of America’s July 26 brief was in response to the federal government’s June 11 filing accusing PhRMA of a “brazen strategy” to upend the entire 340B program, and asking the court to throw out the association’s lawsuit against the ADR final rule. PhRMA sued the U.S. Health and Human Services Department (HHS) and the U.S. Health Resources and Services Administration (HRSA) in January over the ADR final rule and HRSA’s requirements for manufacturer audits of 340B covered entities.
Regulations establishing a binding administrative dispute resolution (ADR) process for the 340B program were rushed into place last December to defeat lawsuits, are fatally flawed legally and constitutionally, and should be struck down, the main U.S. trade association for drug manufacturers told a federal judge late last month.
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