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PhRMA Seeking Injunction Against 340B Orphan Drug Exclusion Rule

 
• By Cathy Kelly

The trade group files a lawsuit seeking preliminary and permanent injunctions against implementation of a final rule that requires 340B discounts for the non-orphan uses of drugs with an orphan designation.

The Pharmaceutical Research and Manufacturers of America is asking a federal court to bar implementation of the HHS final rule determining that orphan drugs are subject to the deep manufacturer discounts provided to certain safety net health care facilities covered by the 340B program when they are used for non-orphan indications.

In a lawsuit filed Sept. 27 in federal court for the District of Columbia, PhRMA argues that the final rule...

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