ACA Orphan Drug Interpretive Rule Oversteps Agency’s Powers, Judge Says
Mealey's (October 19, 2015, 2:37 PM EDT) -- WASHINGTON, D.C. — An agency’s interpretive rule involving orphan drugs and price-cap regulations exceeds statutory power granted to it by the Patient Protection and Affordable Care Act (ACA), a federal judge in the District of Columbia held Oct. 14 (Pharmaceutical Research and Manufacturers of America v. United States Department of Health and Human Services, et al., No. 14-1685, D. D.C.; 2015 U.S. Dist. LEXIS 139617).
(Opinion available. Document #93-151028-004Z.)
In July 2013, the U.S. Department of Health and Human Services (HHS) introduced a final rule governing...