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. 2021 May 26;16(5):e0252155.
doi: 10.1371/journal.pone.0252155. eCollection 2021.

Characteristics and conflicts of interest at Food and Drug Administration Gastrointestinal Drug Advisory Committee meetings

Rishad Khan  1 , Karam Elsolh  2   3 , Nikko Gimpaya  2 , Michael A Scaffidi  2   4 , Rishi Bansal  2   3 , Samir C Grover  1   2   5
Affiliations

Characteristics and conflicts of interest at Food and Drug Administration Gastrointestinal Drug Advisory Committee meetings

Rishad Khan et al. PLoS One. .

Abstract

Introduction: The United States Food and Drug Administration (FDA) Gastrointestinal Drug Advisory Committee (GIDAC) is involved in gastrointestinal drug application reviews. Characteristics and conflicts of interest (COI) in GIDAC meetings are not well described. This study analyzed FDA GIDAC meetings and characteristics that predict recommendations.

Methods: In this cross-sectional study, all publicly available GIDAC meetings where proposed medications were voted on were included. Data were collected regarding indications, medication sponsor, primary efficacy studies, and voting member characteristics (e.g. committee membership, COI). Univariate analyses were conducted at per-meeting and per-vote levels to assess for predictors of committee recommendation and individual votes respectively.

Results: Thirty-four meetings with 476 individual votes from 1998-2018 were included. Twenty-three (68%) proposals were recommended for approval and 25 (74%) received FDA approval. Most proposals involved >1 primary study (n = 27, 79%). At least one voting member had a COI in 24 (71%) of 34 meetings. Twelve (35%) meetings had at least one sponsor COI. Among 476 individual votes, 74 (15.5%) involved a COI, with 33 (6.9%) sponsor COI. COI decreased significantly over time, with fewer COI in 2006-2010, 2011-2015, and 2016-2020 compared to 1996-2000 and 2001-2005 (p<0.01). There were no significant associations between pre-defined predictors, including COI, and committee level recommendations or individual votes (p>0.05 for all univariate analyses).

Conclusions: The GIDAC reviewed 34 proposals from 1998-2018. The majority were recommended for approval and later approved by the FDA, highlighting the GIDAC's prominence in the regulatory process. COI are present among GIDAC panelists but decreasing over time and not associated with recommendations.

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Conflict of interest statement

Rishad Khan has received research grants from Abbvie and Ferring Pharmaceuticals and research funding from Pendopharm. Samir C. Grover has received research grants and personal fees from Takeda, education grants from Janssen, and has equity in Volo Healthcare. All other authors have no relevant disclosures. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. Percentage of votes at Gastrointestinal Drug Advisory Committee meetings with member conflict of interest, stratified by 5-year time intervals.
Fig 2
Fig 2. Value of payments for the 74 votes that involved conflicts of interest.
See this image and copyright information in PMC

References

    1. Ciociola AA, Karlstadt RG, Pambianco DJ, Woods KL, Ehrenpreis ED, FDA-Related Matters Committee of the American College of Gastroenterology. The Food and Drug Administration advisory committees and panels: how they are applied to the drug regulatory process. American Journal of Gastroenterology. 2014;109: 1508–1512. 10.1038/ajg.2014.85 - DOI - PubMed
    1. Hayes MJ, Prasad V. Financial conflicts of interest at FDA drug advisory committee meetings. Hastings Center Report. 2018;48: 10–13. 10.1002/hast.833 - DOI - PubMed
    1. U.S. Department of Health and Human Services, Food and Drug Administration. Guidance for Industry Advisory Committee Meetings—Preparation and Public Availability of Information Given to Advisory Committee Members. Rockville, Maryland, United States; 2008 Aug. Available: https://www.fda.gov/media/75436/download
    1. Zhang AD, Schwartz JL, Ross JS. Association Between Food and Drug Administration Advisory Committee Recommendations and Agency Actions, 2008–2015. The Milbank Quarterly. 2019;97: 796–819. 10.1111/1468-0009.12403 - DOI - PMC - PubMed
    1. Rosenbaum L. Beyond moral outrage—weighing the trade-offs of COI regulation. N Engl J Med. 2015;372: 2064–2068. 10.1056/NEJMms1502498 - DOI - PubMed

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