January 15, 2009
Reprints guidance has strings attached
Drug company reps can distribute--but not discuss--reprints of journal articles on off-label uses for drugs, according to an FDA guidance posted last month.
The guidance comes with numerous conditions. As in the draft guidance issued a year ago, reps can distribute articles or texts to doctors, but they must be separated from promotional materials and “should not be the subject of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The agency made some changes based on comments received about the draft guidance, including adding language encouraging manufacturers “to seek approvals and clearance for new indications and intended uses for medical products.” The guidance also includes several pages of bullet-pointed addenda on the types of reprints and information considered appropriate and the manner in which companies can distribute information.
FDA dismissed calls for the agency to continue requiring pre-submission of articles, as was mandated under an earlier clause governing reprints which expired in 2006. “Given the sunset of section 401 of FDAMA, these were not within FDA's authority and thus outside the scope of this guidance,” the agency said in a notice printed in the Federal Register.
The guidance says 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 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. The Prescription Project greeted the news with the quip, on its PostScript blog: “Physicians who see drug reps: be prepared to be flooded with reprints from journals you've never heard of.”
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.