FDA Involvement in Off-Label Use: Debate between Richard Epstein and Ryan Abbott

25 Pages Posted: 11 Apr 2015 Last revised: 19 Jun 2016

Richard A. Epstein

New York University School of Law; Stanford University - Hoover Institution on War, Revolution and Peace; University of Chicago - Law School

Ryan Abbott

University of Surrey School of Law; University of California, Los Angeles - David Geffen School of Medicine

Date Written: April 9, 2015

Abstract

Before a drug can be sold legally in the United States, the Food and Drug Administration (FDA) must approve it as safe and effective for a particular indication or use — the use then appears on the drug's label. Federal law, however, allows doctors to prescribe drugs that the FDA has approved for one indication for any other indication, even though the FDA never evaluated the safety or efficacy of the drug for that use.

Off-label prescribing is an integral part of modern-day medicine. Patients may benefit when they receive drugs or devices in contexts not approved by the FDA. In fact, in some instances an off-label use may be the standard of care for a particular health problem. However, off-label prescribing can also harm patients, especially when an off-label use lacks a solid evidentiary basis.

For this reason, the FDA forbids drug companies from promoting their own products for off-label use, except for certain activities such as disseminating research literature and sponsoring educational programs. In recent years, civil and criminal actions against drug companies for illegal promotion for off-label use have proliferated, leading to many large settlements. For example, in July 2012, GlaxoSmithKline pled guilty and paid $3 billion to resolve criminal and civil liability arising from the company's unlawful prescription drug promotion, failure to report safety data, and false price reporting practices.

As a result of this recent litigation, many have questioned the FDA's current role in regulation of off-label use and whether more or less intervention is needed. This debate sought to address these very issues.

Keywords: Food and Drug Administration, Administrative Law, Health, Pharmaceutical Policy, Off-Label Drug Use

Suggested Citation

Epstein, Richard A. and Abbott, Ryan, FDA Involvement in Off-Label Use: Debate between Richard Epstein and Ryan Abbott (April 9, 2015). Southwestern University Law Review, Vol. 44, No. 1, 2015. Available at SSRN: https://ssrn.com/abstract=2592816

Richard A. Epstein

New York University School of Law ( email )

40 Washington Square South
New York, NY 10012
United States
(212) 992-8858 (Phone)
(212) 995-4894 (Fax)

Stanford University - Hoover Institution on War, Revolution and Peace

Stanford, CA 94305-6010
United States

University of Chicago - Law School ( email )

1111 E. 60th St.
Chicago, IL 60637
United States
773-702-9563 (Phone)
773-702-0730 (Fax)

Ryan Benjamin Abbott (Contact Author)

University of Surrey School of Law ( email )

Guildford
Guildford, Surrey GU2 5XH
United Kingdom

University of California, Los Angeles - David Geffen School of Medicine ( email )

1000 Veteran Avenue, Box 956939
Los Angeles, CA 90095-6939
United States

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