Drug company representatives will now be able to distribute reprints of journal articles on off-label uses for drugs, according to a US Food and Drug Administration (FDA) guidance.
While the guidance, titled 'Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices US', is expected to irk industry critics, it comes with several 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' programmes.'
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, and reports of phase 1 trials in healthy subjects or reference publications that contain little or no substantive discussion.
Information must be unabridged and cannot be marked, highlighted, summarised or otherwise manipulated by the manufacturer. Also, reprints must be accompanied by a 'prominently displayed and permanently affixed statement' noting that the uses discussed are unapproved by FDA and any financial ties between the manufacturer and the study's authors.
Regulations, guidelines and other institutional frameworks
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