Public Speaker Characteristics at Meetings of the Dermatologic and Ophthalmic Drug Advisory Committee and the Ophthalmic Devices Panel

Mostafa H. Khattab, Michael Weaver, Courtney Cook, Nicholas Kinder, Matt Vassar

Research output: Contribution to journalArticlepeer-review

Abstract

Purpose: We investigated meetings of the Dermatologic and Ophthalmic Drug Advisory Committee (DODAC) and the Ophthalmic Devices Panel (ODP) of the Food and Drug Administration (FDA) to determine whether a relationship exists between receipt of industry payments by speakers of the Open Public Hearing (OPH) portion and the nature of their recommendations regarding treatment approval. Design: Cross-sectional study. Methods: We reviewed publicly available transcripts of all DODAC and ODP meetings from February 2009 to December 2019. For each meeting, information about each public speaker including presence of conflict of interest (COI) and whether their testimony regarding the drug or device was positive, negative, or neutral toward treatment approval was extracted in a blinded fashion using a pilot-tested Google Form. Results: Of the 86 speakers, 66 (76.7%) included a COI disclosure statement and 41 (47.7%) disclosed a COI. Regarding classification of the speakers' testimonies, 70 (81.4%) of 86 were positive, 9 (10.5%) of 86 were negative, and 7 (8.1%) of 86 were neutral. Each one of the 41 speakers with a COI gave a positive testimony. Speakers who disclosed a COI were significantly more likely to give a positive testimony than speakers who did not (P < .001). Conclusion: We recommend the DODAC and ODP require full disclosure of COI information and introduce stricter policies to manage COIs, allowing the committee to fully understand the context of the public speakers' comments, including the possible influence of COI on these comments.

Original languageEnglish
Pages (from-to)28-32
Number of pages5
JournalAmerican Journal of Ophthalmology
Volume223
DOIs
StatePublished - Mar 2021

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