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Health Law, Ethics, and Human Rights
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Volume 360:1557-1566 April 9, 2009 Number 15
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Shifting Terrain in the Regulation of Off-Label Promotion of Pharmaceuticals
Michelle M. Mello, J.D., Ph.D., M.Phil., David M. Studdert, LL.B., Sc.D., M.P.H., and Troyen A. Brennan, M.D., J.D., M.P.H.

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-PubMed Citation
In regulating the promotion of unapproved, or off-label, uses of approved drugs, the Food and Drug Administration (FDA) has sought to strike a balance between supporting the ability of physicians to prescribe according to their best clinical judgment and preventing drug manufacturers from inappropriately driving prescribing practices. The agency has long maintained the general position that although physicians may freely prescribe drugs for off-label uses, drug manufacturers may not promote such uses. However, the FDA's specific regulatory strategy has varied over time, particularly regarding the extent to which manufacturers may disseminate information about off-label uses. In January, the FDA issued . . . [Full Text of this Article]

Mechanisms of Off-Label Promotion and Its Detection

FDA Regulation — Past and Present

Historical Evolution

Challenges to FDA Authority

The 2009 Guidance

Litigation Concerning Off-Label Promotion

What Does the Future Hold?


Source Information

From the Department of Health Policy and Management, Harvard School of Public Health, Boston (M.M.M.); the Schools of Law and Population Health, University of Melbourne, Melbourne, Australia (D.M.S.); and CVS Caremark, Woonsocket, RI (T.A.B.).



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