25 Pages Posted: 11 Apr 2015 Last revised: 19 Jun 2016
Date Written: April 9, 2015
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: 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