Should benefit–risk assessment have its own drug “label”?
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 imp...
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doaj-99968b5107964dc488043605915cb79e2020-11-25T01:59:22ZengDove Medical PressDrug, Healthcare and Patient Safety1179-13652011-08-012011default3741Should benefit–risk assessment have its own drug “label”?Braithwaite RSR 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 assessmenthttp://www.dovepress.com/should-benefitndashrisk-assessment-have-its-own-drug-ldquolabelrdquo-a8011 |
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DOAJ |
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English |
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Article |
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DOAJ |
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Braithwaite RS |
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Braithwaite RS Should benefit–risk assessment have its own drug “label”? Drug, Healthcare and Patient Safety |
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Braithwaite RS |
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Braithwaite RS |
title |
Should benefit–risk assessment have its own drug “label”? |
title_short |
Should benefit–risk assessment have its own drug “label”? |
title_full |
Should benefit–risk assessment have its own drug “label”? |
title_fullStr |
Should benefit–risk assessment have its own drug “label”? |
title_full_unstemmed |
Should benefit–risk assessment have its own drug “label”? |
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should benefit–risk assessment have its own drug “label”? |
publisher |
Dove Medical Press |
series |
Drug, Healthcare and Patient Safety |
issn |
1179-1365 |
publishDate |
2011-08-01 |
description |
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 assessment |
url |
http://www.dovepress.com/should-benefitndashrisk-assessment-have-its-own-drug-ldquolabelrdquo-a8011 |
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