Location of Repository

Should benefit–risk assessment have its own drug “label”?

By Braithwaite RS

Abstract

R Scott BraithwaiteSection of Value and Comparative Effectiveness, Division of General Internal Medicine, New York University School of Medicine, New York, NY, USAAbstract: Many consumers and clinicians incorrectly believe that the Food and Drug Administration (FDA) approval of a new therapeutic implies that its benefits have been proven to exceed its harms. While the FDA could require proof that benefits exceed harms prior to approval, it has been argued that this approach would be infeasible because of prohibitively large sample sizes. One possible alternative would be for the FDA to supplement its standard “label” denoting “safe and effective” with a secondary “label” denoting benefits have been demonstrated to exceed harms, which would be granted only after sufficient post-marketing data had accumulated to prove that its benefits exceeded its harms. This secondary label would not necessarily be linked to marketing restrictions or other commercial prohibitions but, rather, would be only information for consumers and clinicians. Strengths, weaknesses, and feasibility challenges of this approach are discussed.Keywords: drug label, Food and Drug Administration, safety, efficacy, benefit–risk assessmen

Topics: Medicine (General), R5-920, Medicine, R, DOAJ:Medicine (General), DOAJ:Health Sciences
Publisher: Dove Medical Press
Year: 2011
OAI identifier: oai:doaj.org/article:99968b5107964dc488043605915cb79e
Journal:
Download PDF:
Sorry, we are unable to provide the full text but you may find it at the following location(s):
  • https://doaj.org/toc/1179-1365 (external link)
  • http://www.dovepress.com/shoul... (external link)
  • https://doaj.org/article/99968... (external link)
  • Suggested articles


    To submit an update or takedown request for this paper, please submit an Update/Correction/Removal Request.