May 28, 2014 U.S. District Court Agrees With PhRMA, Vacates HRSA 340B Orphan Drug Rule

By Jay W. Cormier & Alan M. Kirschenbaum –

Last summer, the Health Resources and Services Administration (“HRSA”) promulgated a final regulation to implement a statutory provision, added by the Affordable Care Act, that excludes orphan drugs from the ceiling price limitations of the 340B Program when the drugs are purchased by certain covered entities.   As described in our previous post on the final rule, it provided that the orphan drug exclusion applies only to orphan drugs when used for the rare condition or disease for which that orphan drug was designated.  In other words, under the rule, covered entities are entitled to 340B prices when a drug designated as an orphan drug for one indication is used for a different, non-orphan indication.

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