Back to Journals » Drug, Healthcare and Patient Safety » Volume 3

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

Authors Braithwaite RS

Published 3 August 2011 Volume 2011:3 Pages 37—41


Review by Single-blind

Peer reviewer comments 2

R Scott Braithwaite
Section of Value and Comparative Effectiveness, Division of General Internal Medicine, New York University School of Medicine, New York, NY, USA

Abstract: 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 assessment

Creative Commons License This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

Download Article [PDF]  View Full Text [HTML][Machine readable]


Other article by this author:

When patient-centeredness and evidence-based medicine collide

Braithwaite RS

Comparative Effectiveness Research 2014, 4:29-32

Published Date: 5 July 2014

Readers of this article also read:

Effect of different exercise intensities on the pancreas of animals with metabolic syndrome

Amaral F, Lima NEA, Ornelas E, Simardi L, Fonseca FLA, Maifrino LBM

Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy 2015, 8:115-120

Published Date: 13 February 2015

Profile of ocriplasmin and its potential in the treatment of vitreomacular adhesion

Stefanini FR, Maia M, Falabella P, Pfister M, Niemeyer M, Kashani AH, Humayun MS, Koss MJ

Clinical Ophthalmology 2014, 8:847-856

Published Date: 6 May 2014

Analysis of macular cone photoreceptors in a case of occult macular dystrophy

Tojo N, Nakamura T, Ozaki H, Oka M, Oiwake T, Hayashi A

Clinical Ophthalmology 2013, 7:859-864

Published Date: 8 May 2013

Plain abdominal radiography in acute abdominal pain; past, present, and future

Gans SL, Stoker J, Boermeester MA

International Journal of General Medicine 2012, 5:525-533

Published Date: 13 June 2012

Is obesity in women protective against osteoporosis?

Migliaccio S, Greco EA, Fornari R, Donini LM, Lenzi A

Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy 2011, 4:273-282

Published Date: 4 July 2011

Phosphodiesterase-5 inhibitors in management of pulmonary hypertension: Safety, tolerability, and efficacy

Mitchell S Buckley, Robin L Staib, Laura M Wicks, et al

Drug, Healthcare and Patient Safety 2010, 2:151-161

Published Date: 20 September 2010