FDA seeks to permit off-label use of drugs, devices amidst criticism
Despite pleas from Congress to hold off, the FDA Tuesday issued its draft guidance on "Good Reprint Practices" for industry use in the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices.
The draft guidance recommends principles that manufacturers should follow when they distribute scientific or medical journal reprints, articles or reference publications.
According to the draft guidance to be published in the Feb. 20 Federal Register, if manufacturers follow its recommendations and products are lawfully promoted, the FDA would not view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,” said Randall Lutter, FDA deputy commissioner for policy. “The guidance also safeguards against off-label promotion.”
The FDA said it also retains legal authority to determine whether distribution of an article or publication constitutes promotion of an unapproved "new use," or whether such activities cause a product to be considered misbranded or adulterated under The Federal Food, Drug and Cosmetic Act.
The draft guidance is intended to replace a now-expired provision in the FDA Modernization Act that allowed temporary use of journal articles under certain conditions.
However, Rep. Henry Waxman, D-Calif., has said the new guidelines would permit far more dissemination of articles on unapproved uses than was sanctioned under the act.
The FDA said it welcomes public comments on the draft guidance, which should be submitted within 60 days of the Federal Register notice announcing the availability of the draft guidance.
The draft guidance recommends principles that manufacturers should follow when they distribute scientific or medical journal reprints, articles or reference publications.
According to the draft guidance to be published in the Feb. 20 Federal Register, if manufacturers follow its recommendations and products are lawfully promoted, the FDA would not view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,” said Randall Lutter, FDA deputy commissioner for policy. “The guidance also safeguards against off-label promotion.”
The FDA said it also retains legal authority to determine whether distribution of an article or publication constitutes promotion of an unapproved "new use," or whether such activities cause a product to be considered misbranded or adulterated under The Federal Food, Drug and Cosmetic Act.
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.
However, Rep. Henry Waxman, D-Calif., has said the new guidelines would permit far more dissemination of articles on unapproved uses than was sanctioned under the act.
The FDA said it welcomes public comments on the draft guidance, which should be submitted within 60 days of the Federal Register notice announcing the availability of the draft guidance.