Association Between Food and Drug Administration Advisory Committee Recommendations and Agency Actions, 2008-2015.

ABSTRACT: Policy Points Food and Drug Administration (FDA) advisory committee recommendations and the agency's final actions exhibit high rates of agreement, with cases of disagreement tending to reflect the proposed action type and degree of advisory committee consensus. In the case of disagreements, the FDA tended to be less likely than its advisory committees to approve new products, approve new supplemental indications, or enact new safety changes. These findings raise important issues regarding the factors that differentially shape decision making by advisory committees and the FDA as an agency, including institutional or reputational concerns.

Context

The Food and Drug Administration (FDA) convenes advisory committees to provide external scientific counsel on potential agency actions an

SUBMITTER: Zhang AD 

PROVIDER: S-EPMC6739629 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature