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.

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

Grant support

ASK is supported by the Laura and John Arnold Foundation, the FDA, and the Harvard Program in Therapeutic Science, and is a Greenwall Faculty Scholar in Bioethics. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.