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To the Editor: In their Commentary criticizing the guidelines proposed by the Food and Drug Administration (FDA) on off-label promotion, Drs Psaty and Ray¹ point to shortcomings in the peer-reviewed literature about unapproved uses of approved drugs and devices. However, in focusing on sponsors' distribution of such literature, the authors fail to recognize the full extent of the problem.

As Psaty and Ray observe, the published peer-reviewed literature on off-label uses may present an inaccurate picture of a product's risks and benefits. Studies with unfavorable results may not be published, and published studies may be designed and presented in ways that exaggerate benefits and minimize risks. Prohibiting sponsors from distributing peer-reviewed literature on off-label use will not rectify the situation, however, for physicians rely on that very same literature to guide their off-label prescribing.

Without rigorous studies and independent evaluation of a product's off-label effects, physicians lack solid support for . . . [Full Text of this Article]

Rebecca Dresser, JD
dresser@wulaw.wustl.edu
Washington University School of Law
St Louis, Missouri

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FDA Guidance on Off-Label Promotion and the State of the Literature From Sponsors
Bruce M. Psaty and Wayne Ray
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