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- Title
Pharmaceutical Marketing, the FDA, and Free Speech.
- Authors
HEMPHILL, THOMAS A.
- Abstract
The article reflects on the decision of the District Court for the Southern District of New York in August 2015 that Irish drugmaker Amarin could tout the beneficial effects of its triglyceride-lowering drug Vascepa, on a wider class of patients than what the Food and Drug Administration (FDA) had approved. It notes the Justice Department's argument that Amarin's appeal was a frontal assault on the FDA's drug approval regulatory framework.
- Subjects
AMARIN Corp. PLC; UNITED States. Food &; Drug Administration; UNITED States. Dept. of Justice; UNITED States. District Court (New York : Southern District); DRUG approval; TRIGLYCERIDES; ACTIONS &; defenses (Law); THERAPEUTICS
- Publication
Regulation, 2015, Vol 38, Issue 4, p13
- ISSN
0147-0590
- Publication type
Article