In February, the Food and Drug Administration issued a draft guidance, “Good Reprint Practices,” that would allow drug and device companies some leeway in off-label promotion. The guidance would permit companies to give doctors reprints of articles from medical journals about unapproved uses of drugs and devices, within certain parameters. The proposal is similar to guidelines that were in effect since the late 1990s, but expired in 2006.
“Articles that discuss unapproved uses of FDA-approved drugs and devices can contribute to the practice of medicine and may even constitute a medically recognized standard of care,” said Randall Lutter, FDA deputy commissioner for policy, in a press release.
Reprint distribution would have to be separate from distribution of promotional materials. The guidance states the reprints may be distributed at medical conferences “in settings appropriate for scientific exchange.” However, they should not be distributed in exhibit halls or during promotional programs.
But such a move would only “increase the complexity of the already embattled environment of medical education,” says Jane Chin, PhD, president, Medical Liaison Institute, Los Angeles, “especially given the FDA's elusiveness in specifically defining what constitutes a bona fide scientific exchange. Setting physical limits on where such distribution can occur introduces new parameters the FDA is now obligated to define, defend, and amend.”
For more information, visit www.FDA.gov.