Conflicts of interest in United States food and drug administration advisory committees: a systematic literature review
File(s)
Published version
Author(s)
Gentilini, Arianna
Raymakers, Adam JN
Rand, Leah Z
Type
Journal Article
Abstract
Objectives
To systematically review empirical evidence on the prevalence and influence of conflicts of interest (COIs) among members and public speakers of US Food and Drug Administration (FDA) advisory committees.
Methods
Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we searched MEDLINE, PubMed, and Cochrane Library from inception to November 2024 for peer-reviewed studies reporting quantitative data on COIs in FDA advisory committees. Eligible studies examined prevalence, type, or impact of COIs among voting members or public speakers. Data extraction and quality assessment were conducted independently by 2 reviewers using the Joanna Briggs Institute checklist for cross-sectional studies.
Results
Eighteen studies published between 2006 and 2022 were included, covering committee activity from 1997 to 2022. COIs among voting members ranged from 15% to over 70% of meetings, whereas 25% of public speakers disclosed financial COIs, most commonly consulting fees, research funding, and stock ownership. Evidence linking member COIs to voting outcomes was mixed, with some studies finding no significant association. In contrast, public speakers with financial COIs were consistently more likely to deliver favorable testimony, with odds ratios ranging from 3.0 to 6.1. Several studies suggested a decline in member COI prevalence after the 2007 FDA Amendments Act, but no similar trend was observed among public speakers.
Conclusions
COIs remain prevalent in FDA advisory committees, particularly among public speakers, for which they are strongly associated with favorable testimony. These findings underscore the need for stronger and more consistent COI disclosure and management policies that include both committee members and public speakers to protect decision-making integrity.
To systematically review empirical evidence on the prevalence and influence of conflicts of interest (COIs) among members and public speakers of US Food and Drug Administration (FDA) advisory committees.
Methods
Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we searched MEDLINE, PubMed, and Cochrane Library from inception to November 2024 for peer-reviewed studies reporting quantitative data on COIs in FDA advisory committees. Eligible studies examined prevalence, type, or impact of COIs among voting members or public speakers. Data extraction and quality assessment were conducted independently by 2 reviewers using the Joanna Briggs Institute checklist for cross-sectional studies.
Results
Eighteen studies published between 2006 and 2022 were included, covering committee activity from 1997 to 2022. COIs among voting members ranged from 15% to over 70% of meetings, whereas 25% of public speakers disclosed financial COIs, most commonly consulting fees, research funding, and stock ownership. Evidence linking member COIs to voting outcomes was mixed, with some studies finding no significant association. In contrast, public speakers with financial COIs were consistently more likely to deliver favorable testimony, with odds ratios ranging from 3.0 to 6.1. Several studies suggested a decline in member COI prevalence after the 2007 FDA Amendments Act, but no similar trend was observed among public speakers.
Conclusions
COIs remain prevalent in FDA advisory committees, particularly among public speakers, for which they are strongly associated with favorable testimony. These findings underscore the need for stronger and more consistent COI disclosure and management policies that include both committee members and public speakers to protect decision-making integrity.
Date Issued
2026-06-01
Date Acceptance
2026-01-23
Citation
Value in Health, 2026, 29 (6), pp.1105-1113
ISSN
1098-3015
Publisher
Elsevier
Start Page
1105
End Page
1113
Journal / Book Title
Value in Health
Volume
29
Issue
6
Copyright Statement
© 2026, International Society for Pharmacoeconomics and Outcomes Research, Inc. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
License URL
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/41654012
PII: S1098-3015(26)00045-8
Subjects
FDA
advisory committees
conflicts of interest
Publication Status
Published
Coverage Spatial
United States
Date Publish Online
2026-02-05