The U.S. Department of Health and Human Services filed a response on June 12, 2014 in U.S. District Court in response to the Court’s May 23rd decision invalidating HRSA’s 340B/orphan drug regulation.
The U.S. Department of Health and Human Services filed a response on June 12, 2014 in U.S. District Court in response to the Court’s May 23rd decision invalidating HRSA’s 340B/orphan drug regulation.
The court’s decision in May found that HRSA lacked the authority to “regulate” in this area, but invited the agency to provide further briefing on whether it could characterize its regulation as an “interpretive” regulation. The government’s response filed yesterday notes that HHS is declining to provide further briefing as offered by the Court, but indicates that the department still is considering whether to appeal.
Most notably, the government’s response says, “HHS does not interpret the Court’s decision as precluding it from issuing an interpretive rule or other type of interpretive guidance, even if that rule or guidance sets forth the same interpretation previously embodied in the challenged regulation.” This statement could signal that HRSA intends to re-issue the orphan drug rule not as a regulation, but as an interpretive guidance.
