FDA Draft Guidance Permits Use of Off-Label Information

Ignoring pleas from Congress to hold off, the FDA is pushing ahead with a controversial set of recommendations that would permit device companies to distribute journal articles discussing off-label uses of their products.

According to a draft guidance published in the Federal Register last week, if manufacturers follow the FDA’s recommendations and products are lawfully promoted, the agency would not view distribution of medical and scientific information as evidence of manufacturer intent to promote an unapproved use.

“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,” Randall Lutter, FDA deputy commissioner for policy, said. “The guidance also safeguards against off-label promotion.”

The draft guidance is intended to replace a now-expired provision in the FDA Modernization Act that allowed temporary use of journal articles under certain conditions. But the new guidelines would permit far more dissemination of articles on unapproved uses than was sanctioned under the act, Rep. Henry Waxman (D-Calif.) has said.

The draft guidance, “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved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,” can be seen at www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0053-gdl.pdf.