Implementing a Public Health Perspective in FDA Drug Regulation

Food and Drug Law Journal, Vol. 73, pp. 221-256, 2018

Georgia State University College of Law, Legal Studies Research Paper No. 2018-21

37 Pages Posted: 11 Jun 2018 Last revised: 27 Sep 2018

See all articles by Patricia J. Zettler

Patricia J. Zettler

Georgia State University - College of Law

Margaret Foster Riley

University of Virginia School of Law

Aaron S. Kesselheim

Brigham and Women's Hospital/Harvard Medical School; Harvard University - Edmond J. Safra Center for Ethics

Date Written: 2018

Abstract

There is, without question, a public health crisis in the United States arising from both illicit and prescription opioid misuse, addiction, and overdose. The Food and Drug Administration (FDA) is one regulator with an important role to play in minimizing the harms associated with prescription opioids, while also ensuring that prescription opioids are available for the evidence-based management of pain. One question, however, is to what extent the agency can consider in its decisions to approve opioids and keep existing ones on the market the provider and patient behaviors contributing to the epidemic. This is, in part, because FDA’s approval of drugs is often understood as narrowly focused on weighing the benefits and risks of the products as defined in the preapproval clinical trials that are used to set the drug’s official FDA-approved indication. Such a limited focus would exclude important information about the real-world use and public-health impact of prescription opioids and other drugs with externalities. This Article argues that, to better regulate drugs like opioids that have such externalities, one step FDA should take is to use a “public health” perspective in its approval (and withdrawal) decisions. The Article describes how the federal Food, Drug, and Cosmetic Act authorizes FDA to take this broad approach in its drug approval and withdrawal decisions and offers some principles for implementing this approach systematically.

Keywords: opioid, FDA, public health, public health law, health law, food and drug administration, drug regulation, drug approval, Food Drug and Cosmetic Act, opioid misuse, food and drug law, law, administrative law, agency

JEL Classification: I12, I18, K23, K32

Suggested Citation

Zettler, Patricia J. and Riley, Margaret Foster and Kesselheim, Aaron S., Implementing a Public Health Perspective in FDA Drug Regulation (2018). Food and Drug Law Journal, Vol. 73, pp. 221-256, 2018; Georgia State University College of Law, Legal Studies Research Paper No. 2018-21. Available at SSRN: https://ssrn.com/abstract=3193096

Patricia J. Zettler (Contact Author)

Georgia State University - College of Law ( email )

P.O. Box 4037
Atlanta, GA 30302-4037
United States

Margaret Foster Riley

University of Virginia School of Law ( email )

580 Massie Road
Charlottesville, VA 22903
United States

HOME PAGE: http://www.law.virginia.edu

Aaron S. Kesselheim

Brigham and Women's Hospital/Harvard Medical School ( email )

1620 Tremont St
Suite 3030
Boston, MA 02120
United States
617-278-0930 (Phone)
617-232-8602 (Fax)

HOME PAGE: http://www.drugepi.org/portal

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

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

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