Court says Congress has the power to make the change that HHS attempted with its Interpretive Rule, and thus it should be left to the legislative branch. A lawsuit challenging the Interpretive Rule, filed by the...more
10/26/2015
/ Affordable Care Act ,
Department of Health and Human Services (HHS) ,
Discounts ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Facilities ,
Interpretive Rule ,
Orphan Drugs ,
Pharmaceutical Industry ,
PHRMA ,
PHSA ,
Prescription Drugs ,
Public Health Service Act ,
Section 340B
On July 21, 2014, the U.S. Department of Health and Human Services (HHS) released an “Interpretive Rule” in response to a recent U.S. District Court decision that vacated the July 23, 2013, orphan drug rule on the grounds...more
On June 18, 2014, the U.S. Department of Health and Human Services (HHS) publicly stated that the recent decision of the U.S. District Court for the District of Columbia to vacate HHS’s regulation covering orphan drugs and...more