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Dr. Randall Stafford objects to the FDA refusing to regulate off-label drug use

   Dr. Stafford recently authored an article objecting to the FDA's proposed new rules which would allow broader off-label drug use by easing restrictions on marketing drugs for off-label use.    "Off-label" drug use is the term used when physicians (legally) prescribe a drug for a use that has never been scientifically supported and for which the drug was not expressly approved.  Currently, physicians are allowed to exercise this discretion, however, drug reps are not allowed to promote off-label uses. 

     This proposed easing of regulations is yet another example of the Bush Administration's round-heeled approach to industry regulation and its coziness with the pharmaceutical industry, in particular.  In short, the Bush Administration has yet to meet a henhouse that it wouldn't regulate by inserting a fox, and Dr. Stafford judiciously identifies the problems with this approach. 

    The FDA's role should be to assure that medications are used only where scientific data supports their use, and it should be the clearinghouse that controls the dissemination of accurate, balanced information on data.  If it eschews this role and allows drug marketers who have a profit incentive to control the flow of information to harried doctors, no good can come to consumers.

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