Sunday, February 17, 2008

FDA to offer guidance to companies on marketing drugs for unapproved uses

From CBC News:
The U.S. government on Friday proposed guidelines for how pharmaceutical companies can use medical journal articles to market drugs for unapproved uses.

The Food and Drug Administration guidelines, criticized by some legislators as too lenient, have been eagerly anticipated by drug and device companies like Pfizer Inc. and Medtronic Inc. that often use medical literature for marketing.

Companies are not allowed to market products for "off-label" uses, or those that have not been cleared by the FDA as safe and effective. However, under a law that expired in 2006, the agency made an exception for reprints of medical journal articles, which sales people often give to physicians. ...more

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