HHS Asks DC Court To Nix PhRMA's 340B Orphan Drug Suit

Law360, New York (January 28, 2015, 4:01 PM EST) -- The U.S. Department of Health and Human Services asked a D.C. federal court Tuesday to toss Pharmaceutical Research and Manufacturers of America's complaint challenging a department rule on discounting so-called orphan drugs in the 340B program, saying the interpretive rule wasn't subject to the court's review.

HHS issued the rule in July, setting out the agency's reading of an Affordable Care Act provision that, in some health care settings, exempts drugs from the discount requirement if they're designated for a rare disease. HHS has threatened to severely discipline drugmakers if they withhold discounts on the orphan drugs when they're used for relatively...

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