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Physicians’ Trust in the FDA’s Use of Product-Specific Pathways for Generic Drug Approval

BACKGROUND: Generic drugs are cost-effective versions of brand-name drugs approved by the Food and Drug Administration (FDA) following proof of pharmaceutical equivalence and bioequivalence. Generic drugs are widely prescribed by physicians, although there is disagreement over the clinical comparabi...

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Autores principales: Kesselheim, Aaron S., Eddings, Wesley, Raj, Tara, Campbell, Eric G., Franklin, Jessica M., Ross, Kathryn M., Fulchino, Lisa A., Avorn, Jerry, Gagne, Joshua J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5074566/
https://www.ncbi.nlm.nih.gov/pubmed/27768700
http://dx.doi.org/10.1371/journal.pone.0163339
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author Kesselheim, Aaron S.
Eddings, Wesley
Raj, Tara
Campbell, Eric G.
Franklin, Jessica M.
Ross, Kathryn M.
Fulchino, Lisa A.
Avorn, Jerry
Gagne, Joshua J.
author_facet Kesselheim, Aaron S.
Eddings, Wesley
Raj, Tara
Campbell, Eric G.
Franklin, Jessica M.
Ross, Kathryn M.
Fulchino, Lisa A.
Avorn, Jerry
Gagne, Joshua J.
author_sort Kesselheim, Aaron S.
collection PubMed
description BACKGROUND: Generic drugs are cost-effective versions of brand-name drugs approved by the Food and Drug Administration (FDA) following proof of pharmaceutical equivalence and bioequivalence. Generic drugs are widely prescribed by physicians, although there is disagreement over the clinical comparability of generic drugs to brand-name drugs within the physician community. The objective of this survey was to assess physicians' perceptions of generic drugs and the generic drug approval process. METHODS AND FINDINGS: A survey was administered to a national sample of primary care internists and specialists between August 2014 and January 2015. In total, 1,152 physicians comprising of internists with no reported specialty certification and those with specialty certification in hematology, infectious diseases, and endocrinology were surveyed. The survey assessed physicians’ perceptions of the FDA’s generic drug approval process, as well as their experiences prescribing six generic drugs approved between 2008 and 2012 using product-specific approval pathways and selected comparator drugs. Among 718 respondents (62% response rate), a majority were comfortable with the FDA’s process in ensuring the safety and effectiveness of generic drugs overall (91%) and with letting the FDA determine which tests were necessary to determine bioequivalence in a particular drug (92%). A minority (13–26%) still reported being uncomfortable prescribing generic drugs approved using product-specific pathways. Overall, few physicians heard reports of concerns about generic versions of the study drugs or their comparators, with no differences between the two groups. Physicians tended to hear about concerns about the safety or effectiveness of generic drugs from patients, pharmacists, and physician colleagues. CONCLUSIONS: Physicians hold largely positive views of the FDA's generic drug approval process even when some questioned the performance of certain generic drugs in comparison to brand-name drugs. Better education about the generic drug approval process and standards may alleviate concerns among the physician community and support the delivery of cost-effective health care.
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spelling pubmed-50745662016-11-04 Physicians’ Trust in the FDA’s Use of Product-Specific Pathways for Generic Drug Approval Kesselheim, Aaron S. Eddings, Wesley Raj, Tara Campbell, Eric G. Franklin, Jessica M. Ross, Kathryn M. Fulchino, Lisa A. Avorn, Jerry Gagne, Joshua J. PLoS One Research Article BACKGROUND: Generic drugs are cost-effective versions of brand-name drugs approved by the Food and Drug Administration (FDA) following proof of pharmaceutical equivalence and bioequivalence. Generic drugs are widely prescribed by physicians, although there is disagreement over the clinical comparability of generic drugs to brand-name drugs within the physician community. The objective of this survey was to assess physicians' perceptions of generic drugs and the generic drug approval process. METHODS AND FINDINGS: A survey was administered to a national sample of primary care internists and specialists between August 2014 and January 2015. In total, 1,152 physicians comprising of internists with no reported specialty certification and those with specialty certification in hematology, infectious diseases, and endocrinology were surveyed. The survey assessed physicians’ perceptions of the FDA’s generic drug approval process, as well as their experiences prescribing six generic drugs approved between 2008 and 2012 using product-specific approval pathways and selected comparator drugs. Among 718 respondents (62% response rate), a majority were comfortable with the FDA’s process in ensuring the safety and effectiveness of generic drugs overall (91%) and with letting the FDA determine which tests were necessary to determine bioequivalence in a particular drug (92%). A minority (13–26%) still reported being uncomfortable prescribing generic drugs approved using product-specific pathways. Overall, few physicians heard reports of concerns about generic versions of the study drugs or their comparators, with no differences between the two groups. Physicians tended to hear about concerns about the safety or effectiveness of generic drugs from patients, pharmacists, and physician colleagues. CONCLUSIONS: Physicians hold largely positive views of the FDA's generic drug approval process even when some questioned the performance of certain generic drugs in comparison to brand-name drugs. Better education about the generic drug approval process and standards may alleviate concerns among the physician community and support the delivery of cost-effective health care. Public Library of Science 2016-10-21 /pmc/articles/PMC5074566/ /pubmed/27768700 http://dx.doi.org/10.1371/journal.pone.0163339 Text en © 2016 Kesselheim et al http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Kesselheim, Aaron S.
Eddings, Wesley
Raj, Tara
Campbell, Eric G.
Franklin, Jessica M.
Ross, Kathryn M.
Fulchino, Lisa A.
Avorn, Jerry
Gagne, Joshua J.
Physicians’ Trust in the FDA’s Use of Product-Specific Pathways for Generic Drug Approval
title Physicians’ Trust in the FDA’s Use of Product-Specific Pathways for Generic Drug Approval
title_full Physicians’ Trust in the FDA’s Use of Product-Specific Pathways for Generic Drug Approval
title_fullStr Physicians’ Trust in the FDA’s Use of Product-Specific Pathways for Generic Drug Approval
title_full_unstemmed Physicians’ Trust in the FDA’s Use of Product-Specific Pathways for Generic Drug Approval
title_short Physicians’ Trust in the FDA’s Use of Product-Specific Pathways for Generic Drug Approval
title_sort physicians’ trust in the fda’s use of product-specific pathways for generic drug approval
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5074566/
https://www.ncbi.nlm.nih.gov/pubmed/27768700
http://dx.doi.org/10.1371/journal.pone.0163339
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