Off-Label Drug Use and Promotion: Balancing Public Health Goals and Commercial Speech

33 Pages Posted: 23 Mar 2014  

Aaron S. Kesselheim

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

Date Written: March 18, 2011

Abstract

In this article, I first discuss the complex intersection of the drug label and evidence-based medicine. Next, I review the phenomenon of off-label promotion and the controversy that has arisen over FDA regulations related to this field. The controversy over the FDA's authority to regulate off-label promotion can be traced to the essential mismatch between appropriate drug uses and the label. Thus, in the final section, I examine ways to resolve this conflict through changes to the supplemental new drug approval process that can better align restrictions on promotion with knowledge about evidence-based medicine.

Keywords: Prescription drug, FDA, off-label, pharmaceutical marketing

JEL Classification: H51, I11, I18

Suggested Citation

Kesselheim, Aaron S., Off-Label Drug Use and Promotion: Balancing Public Health Goals and Commercial Speech (March 18, 2011). American Journal of Law and Medicine, Vol. 37, No. 2-3, 2011. Available at SSRN: https://ssrn.com/abstract=2411145

Aaron S. Kesselheim (Contact Author)

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

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Boston, MA 02120
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617-278-0930 (Phone)
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HOME PAGE: http://www.drugepi.org/portal

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

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Cambridge, MA 02138
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