FREE NEJM E-TOC    HOME   |   SUBSCRIBE   |   CURRENT ISSUE   |   PAST ISSUES   |   COLLECTIONS   |   Search Term  Advanced Search

Sign in | Get NEJM's E-Mail Table of Contents — Free | Subscribe

Previous Volume 360:1557-1566 April 9, 2009 Number 15 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

	Full Text PDF PDA Full Text Purchase this article Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear 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.).

This article has been cited by other articles:

• Liang, B. A., Mackey, T. (2010). Reforming Off-Label Promotion to Enhance Orphan Disease Treatment. Science 327: 273-274 [Abstract] [Full Text]