What Should Be Clinicians' Roles in Regulatory Assessment of Prospective Interventions' Risks of Exacerbating Inequity?

Abstract

When there is an evidence base that could be used credibly to justify expedited US Food and Drug Administration review, emergency use authorization, or approval, interventions-in-development must be evaluated in terms of their possible downstream influence on public trust and confidence in regulatory processes during a national public health crisis. When regulatory decisions express overconfidence about a prospective intervention's success, there is risk that the costliness of or misinformation about the intervention will exacerbate health inequity. A converse risk is regulators' underestimation of an intervention's value in treating populations at risk for inequitable care. This article considers the nature and scope of clinicians' roles in regulatory processes in which such risks must be considered and balanced to promote public safety and public health.