Regulating Off-Label Info On Drugs, Medical Devices

Law360, New York (February 2, 2009, 12:00 AM EST) -- In the waning days of the Bush administration, the U.S. Food and Drug Administration released a controversial new guidance document providing recommendations to manufacturers of drugs, medical devices and licensed biologics on how to lawfully distribute information regarding unapproved “off-label” uses for their products.

The guidance applies to medical journal articles and scientific or medical reference publications distributed to health care professionals and health care entities such as hospitals, professional medical organizations, drug formulary committees and health plans.

The federal Food, Drug and Cosmetic Act generally...
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