Five Un-Easy Pieces of Pharmaceutical Policy Reform

10 Pages Posted: 18 Jul 2013 Last revised: 24 May 2014

Marc A. Rodwin

Suffolk University Law School; Harvard University - Edmond J. Safra Center for Ethics

Date Written: August 2013

Abstract

Improper dependencies slant policy over a drug’s life span, biasing the development of new drugs, the testing and marketing approval for new drugs, and the monitoring of patient safety after drugs are marketed. This article examines five ways in which the public improperly depend on pharmaceutical firms that compromises the integrity of pharmaceutical policy. Today the public relies on pharmaceutical firms: (1) to set priorities on drug research and development; (2) to conduct clinical trials to test whether drugs are safe and effective; (3) to decide what clinical trial data to disclose to the public; (4) to monitor post marketing drug safety; (5) to supply product information to physicians and to finance continuing medical education and other professional activities. The article suggests options to overcome each of these dependencies.

Suggested Citation

Rodwin, Marc A., Five Un-Easy Pieces of Pharmaceutical Policy Reform (August 2013). Journal of Law, Medicine and Ethics, Vol. 41, p. 581, 2013; Suffolk University Law School Research Paper No. 13-24. Available at SSRN: https://ssrn.com/abstract=2295002

Marc A. Rodwin (Contact Author)

Suffolk University Law School ( email )

120 Tremont Street
Boston, MA 02108-4977
United States
617-573-8354 (Phone)
617-305-3087 (Fax)

HOME PAGE: http://www.law.suffolk.edu/faculty/directories/faculty.cfm?InstructorID=48

Harvard University - Edmond J. Safra Center for Ethics ( email )

124 Mount Auburn Street
Suite 520N
Cambridge, MA 02138
United States

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