Quick update on the FDA’s draft policy regarding promotion of off-label drug use, which Gavin blogged about last July. Despite widespread negative publicity in the blogosphere along with opposition from health organisations and consumer advocates, the proposals have now been released as formal guidance from the agency. Essentially this policy now means that drug companies can promote off-label drug use by circulating reprints of journal articles describing those uses to doctors. Providing the FDA’s guidance is followed, FDA does not see the activity as “establishing intent that the product be used for an unapproved new use…” We know, for all the reasons described in Gavin’s blog (and in a recent PLoS Medicine article), that promoting off-label use is potentially harmful to patients. (Note also this week Eli Lilly has been reported in BMJ as settling “the largest individual corporate fine in history”, in relation to off-label promotion of olanzapine). Despite this, the policy is described as only “guidance”, with the document stating that “FDA’s guidance documents do not establish legally enforceable rights or responsibilities”. I, and presumably others, are left wondering how it will be possible for the agency to enforce pharmaceutical promotion in the future.
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