340B Program: HRSA Posts Orphan Drug Exclusion Policy, PhRMA Responds

There have been a number of developments since the U.S. District Court for the District of Columbia “vacated,” or invalidated, HRSA’s final rule on the treatment of orphan drugs under the 340B Drug Discount Program. The Health Resources and Services Administration (HRSA), which administers the 340B program, issued the regulation in July 2013. It went into effect on October 1, 2013 and was vacated by the court on May 23, 2014, after a legal challenge brought by the Pharmaceutical Research and Manufacturers of America (PhRMA).

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