HRSA's Final Rule on the 340B Orphan Drug Exclusion Vacated by U.S. District Court for the District of Columbia
23 June 2014Pharmaceutical Compliance Monitor
On Friday, May 23, 2014, 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 case is Pharmaceutical Research and Manufacturers of America v. United States Department of Health and Human Services, et al. The Health Resources and Services Administration (HRSA), which administers the 340B program, released the final rule in July 2013. It went into effect on October 1, 2013. As the court explained in its opinion and order, it vacated the final rule on the ground that the Department of Health and Human Services (HHS), the parent agency to HRSA, lacked the authority to issue a regulation (or "final rule") on that topic.