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FDA Approves Journal Articles for Off-Label Use

// January 27th, 2009 // Pharmacy General

Drug company reps can distribute — but not discuss — reprints of journal articles on off-label uses for drugs, according to an FDA guidance posted today.

The guidance, though sure to irk industry critics, comes with numerous conditions. Reps can distribute articles or texts to doctors, but they must be separated from promotional materials and “should not be the subject of discussion between the sales representative and the physician during the sales visit.” Reprints can be distributed at medical or scientific conferences “in settings appropriate for scientific exchange,” but not “in promotional exhibit halls or during promotional speakers’ programs.”

The agency said articles distributed should be from peer-reviewed journals and must not be false or misleading. Bespoke articles published primarily for distribution by the manufacturer are off-limits, as are letters to the editor, abstracts, reports of Phase 1 trials in healthy subjects or reference publications that contain little or no substantive discussion. [MMM]