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

Khan, R; Elsolh, K; Gimpaya, N; Scaffidi, MA; Bansal, R; Grover, SC

Journal article

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

Abstract:: BackgroundIn April 2024, the Oncology Drug Advisory Committee (ODAC) voted to approve minimal residual disease (MRD) as a new regulatory endpoint for multiple myeloma (MM) despite its poor trial-level surrogacy. This is expected to result in faster MM drug approvals, a potential boon for the pharmaceutical companies that make them. This study investigates the prevalence of financial conflicts of interest (FCOIs) with these companies among United States (US)-based physician speakers at the meeting.MethodsPublic data regarding the past 3 years of pharmaceutical company payments to US-based physician speakers at the ODAC meeting discussing MRD (available at https://openpaymentsdata.cms.gov/) were collected. For each general payment (GP), we recorded the amount, company payor, reason for payment, and associated products. Descriptive analyses were performed on payments from companies who manufacture MM therapeutics (MM payments).Results12 of the 20 physician speakers (60 %) eligible to have FCOIs recorded on the OpenPayments database received MM payments from 2021 to 2023, totaling more than $792,200. A majority of both voting and non-voting members had MM payments (median $11,800 and $764), most of which were consulting fees. Speakers earned more than 3.7 times as much from GPs associated with MM-related products compared to those associated with non-MM-related products.ConclusionMost US-based physician speakers at the April 2024 ODAC meeting had FCOIs from MM companies, including those with voting power.Policy summaryOur findings highlight the need for greater policing of FCOIs among US-based physicians involved in cancer drug regulatory policy

Publication status:: Published

Peer review status:: Peer reviewed

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APA Style

Khan, R., Elsolh, K., Gimpaya, N., Scaffidi, M. A., Bansal, R., & Grover, S. C. (2021). Characteristics and conflicts of interest at Food and Drug Administration Gastrointestinal Drug Advisory Committee meetings. PLoS ONE, 16(5), e0252155–e0252155.

MLA Style

Khan, R, et al. “Characteristics and Conflicts of Interest at Food and Drug Administration Gastrointestinal Drug Advisory Committee Meetings.” PLoS ONE, vol. 16, no. 5, 2021, pp. e0252155–e0252155.

Chicago Style

Khan, R, K Elsolh, N Gimpaya, MA Scaffidi, R Bansal, and SC Grover. 2021. “Characteristics and Conflicts of Interest at Food and Drug Administration Gastrointestinal Drug Advisory Committee Meetings.” PLoS ONE 16 (5): e0252155–e0252155.
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