Perceived Implications of Current Conflict of Interest Policy in Individuals Accepted or Rejected for Participation in Food and Drug Administration Advisory Committee

Abstract

ABSTRACTBackground and ObjectiveThe Food and Drug Administration (FDA) relies on advice from scientific and medical experts to make approval decisions about new prescription medications and medical devices. Therefore, it is crucial that FDA Advisory Committees (ACs) include the most knowledgeable scientists and clinicians in the decision-making process. However, to ensure that the advice is free from biases, current FDA policy often excludes those most qualified from participating in ACs due to perceived conflicts of interest (COI). The objective of the present study is to elicit opinion among subject matter experts regarding current FDA COI rules and regulations.MethodsWe conducted a cross-sectional study using formal, self-administered online survey consisting of 14 questions, 3 of which addressed perceived implications of current FDA COI policy. We send a formal online survey to study subjects via Qualtrics. Study subjects were 1) individuals who participated in FDA ACs and 2) those who were interested in participating in ACs and had completed FDA COI paperwork but rejected by the FDA due to COI. The outcome measure is response to the 3 questions about the perceived implications of current FDA COI policy. Responses were scored on a 5-point Likert-type scale.ResultsAmong 403 study subjects (200 AC members and 203 individuals who were rejected due to COI), 145 (36%) responded to the survey including 90 AC members and 55 rejected individuals. Respondents included 41 (28%) females. 97% were holding MD or PhD degrees. 88% were age 46 and over, and 66% had more than 25 years in practice. The primary findings were that 49% of respondents agreed that the current FDA regulations lead to a lower quality of experts on ACs, 72% agreed that current policies exclude qualified experts from serving on ACs, and 48% agreed that FDA policy lowers the overall quality of AC input, to at least a “moderate” extent (19%-37% to a “high” or “very high” extent).ConclusionsThe prevailing opinion among respondents to the formal survey is that current FDA COI policy has the potential effects to lowering quality of experts, excluding qualified experts, and lowering overall quality of AC input. The present report elucidates a potential need for the FDA to discuss the benefit and risk of the current AC COI policies.