Saturday, February 16, 2008

FDA Proposes Guildelines That Would Allow Industry to Provide Information on Off-Label Uses

Article in the Wall Street Journal -- Boost for Off-Label Drug Use: FDA Would Let Firms Keep Doctors Informed On Unapproved Methods, by Anna Wilde Mathews and Avery Johnson.  Here's an excerpt:

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.

Drug makers are generally expected to welcome the proposal because it clarifies a blurry legal area. At least under certain conditions, it promises a haven for a controversial promotional practice. It also contains an argument from the agency that may help the companies in court cases about marketing practices: There are "important public policy reasons for allowing manufacturers to disseminate truthful and non-misleading medical journal articles" and reference materials about off-label uses.


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