Extra-Judicial Decision-Making for Drug Safety and Risk Management : Evidence from the Fda

This paper assesses the use and value of decision-making (or deliberative) teams in the form of advisory committees for regulation by the FDA. Our theoretical framework is common principles offered in organization theory for the design of such coordination mechanisms. Specifically, we examine the Drug Safety and Risk Management Advisory Committee (DSaRM) with regard to its composition and performance using standard criteria of effectiveness, efficiency, and fairness of deliberations