An Uninformative Truth: The Logic of Amarin's Off-Label Promotion

Spencer Phillips Hey; Aaron S Kesselheim

doi:10.1371/journal.pmed.1001978

An Uninformative Truth: The Logic of Amarin's Off-Label Promotion

PLoS Med. 2016 Mar 15;13(3):e1001978. doi: 10.1371/journal.pmed.1001978. eCollection 2016 Mar.

Authors

Spencer Phillips Hey^{1

2}, Aaron S Kesselheim^{1

2}

Affiliations

¹ The Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, United States of America.
² The Harvard Center for Bioethics, Harvard Medical School, Boston, Massachusetts, United States of America.

Abstract

Spencer Phillips Hey and Aaron Kesselheim propose that informativeness-asserting scientific facts-rather than truthfulness ought to be the standard for regulating commercial speech about pharmaceuticals.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Drug Approval / legislation & jurisprudence*
Drug Industry*
Eicosapentaenoic Acid / analogs & derivatives*
Eicosapentaenoic Acid / therapeutic use
Humans
Hypertriglyceridemia / drug therapy*
Hypolipidemic Agents / therapeutic use*
Jurisprudence
Marketing / legislation & jurisprudence*
Off-Label Use*
United States
United States Food and Drug Administration*

Substances

Hypolipidemic Agents
eicosapentaenoic acid ethyl ester
Eicosapentaenoic Acid