Friday, February 15, 2008

Will off-label uses have another avenue besides CME?

Maybe...from the Wall Street Journal article:
The Food and Drug Administration wants to allow drug companies to give doctors information about unapproved uses of prescription drugs, a controversial move that is already drawing objections from Capitol Hill.

Companies generally aren't allowed to advertise or market such "off-label" uses, though doctors can prescribe drugs for any condition. The FDA has proposed guidelines allowing manufacturers to give physicians reprints of medical journal articles about uses of drugs and medical devices that haven't won the agency's approval.

The regulator is stepping into a high-stakes business issue, because off-label uses of prescription drugs are a mainstay of the industry -- an estimated 21% of drug use overall, according to a 2006 analysis published in the Archives of Internal Medicine.

Click here to access the WSJ article (sub. req.).

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