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

Northwestern University Journal of Technology and Intellectual Property. 5(2):250-264.

Posted: 14 Nov 2005 Last revised: 20 Jan 2015

See all articles by Hazel McMullin

Hazel McMullin

Independent

Andrew B. Whitford

University of Georgia - Department of Public Administration and Policy

Date Written: 2007

Abstract

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.

Keywords: Teams, Regulation, Pharmaceuticals, Advisory Committees

JEL Classification: I18, D73, K20

Suggested Citation

McMullin, Hazel and Whitford, Andrew B., Extra-Judicial Decision-Making for Drug Safety and Risk Management: Evidence from the Fda (2007). Northwestern University Journal of Technology and Intellectual Property. 5(2):250-264., Available at SSRN: https://ssrn.com/abstract=845811 or http://dx.doi.org/10.2139/ssrn.845811

Hazel McMullin

Independent ( email )

Andrew B. Whitford (Contact Author)

University of Georgia - Department of Public Administration and Policy ( email )

Athens, GA 30602
United States
706-542-2898 (Phone)
706-583-0610 (Fax)

HOME PAGE: http://andrewwhitford.com

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