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Should benefit–risk assessment have its own drug “label”?
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 app...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Dove Medical Press
2011
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3163936/ https://www.ncbi.nlm.nih.gov/pubmed/21904466 http://dx.doi.org/10.2147/DHPS.S21927 |
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author | Braithwaite, R Scott |
author_facet | Braithwaite, R Scott |
author_sort | Braithwaite, R Scott |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-3163936 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2011 |
publisher | Dove Medical Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-31639362011-09-08 Should benefit–risk assessment have its own drug “label”? Braithwaite, R Scott Drug Healthc Patient Saf Perspectives 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. Dove Medical Press 2011-08-03 /pmc/articles/PMC3163936/ /pubmed/21904466 http://dx.doi.org/10.2147/DHPS.S21927 Text en © 2011 Braithwaite, publisher and licensee Dove Medical Press Ltd. This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited. |
spellingShingle | Perspectives Braithwaite, R Scott Should benefit–risk assessment have its own drug “label”? |
title | 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”? |
title_short | Should benefit–risk assessment have its own drug “label”? |
title_sort | should benefit–risk assessment have its own drug “label”? |
topic | Perspectives |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3163936/ https://www.ncbi.nlm.nih.gov/pubmed/21904466 http://dx.doi.org/10.2147/DHPS.S21927 |
work_keys_str_mv | AT braithwaiterscott shouldbenefitriskassessmenthaveitsowndruglabel |