https://jamanetwork.com/journals/jama-health-forum/fullarticle/2807050
Association of Advisory Committee Votes With US Food and Drug Administration Decision-Making on Prescription Drugs, 2010-2021
Abstract
Importance The US Food and Drug Administration (FDA) often relies on independent advisory committees when making decisions about the approval of prescription drugs or their withdrawal from the market. These committees provide the FDA with valuable insight and an opportunity to build public trust through transparent deliberation, but recent controversies have raised questions about the optimal use of FDA advisory committees.
Objective To assess the frequency, purposes, and voting outcomes of human drug advisory committees convened from 2010 to 2021 and the FDA’s corresponding actions.
Conclusions
In this qualitative study of FDA advisory committees, recommendations were associated with FDA regulatory actions on prescription drugs, with the FDA acting concordantly with its advisors’ recommendations in a majority of cases and over time. However, a decline was observed from 2010 to 2021 in the number of committees that were consulted and asked to vote on these issues. In cases of discordance, the FDA was more likely to favor approval than were its advisors, and the FDA declined to reconvene advisors before most approvals of drugs that had received a negative vote. Reforms are necessary to clarify the FDA’s commitment to independent expert advice as an integral part of its regulation of prescription drugs.