FDA OKs distribution of journal articles on off-label usesDrug 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.
Information must be unabridged and cannot be marked, highlighted, summarized or otherwise manipulated by the manufacturer, and 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, said 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.
Incoming House Committee on Energy and Commerce Chair Rep. Henry Waxman (D-CA) blasted the rule ahead of the release of draft guidance in December 2007, saying it would establish a means for manufacturers to sidestep the agency review process and create "a powerful disincentive" to conduct clinical trials. Industry advocates weren't thrilled with it either. Last February, Coalition for Healthcare Communication chief John Kamp told MM&M that the guidance met only the stingiest interpretation of companies' First Amendment rights to disseminate information, but allowed that it would "limit the ability of HHS and state investigators under the False Claims Act to essentially make up new policy about off-label means" and restore that authority to FDA.