FDA to Allow Off-Label Information

Rockville, MD (Feb. 15)-The US Food and Drug Administration issued a draft guidance for industry titled “Good Reprint Practices” regarding the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices.

“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 an agency release. “This guidance also safeguards against off-label promotion.”

Industry has been asking for clarification of “off-label” use since late September, when Section 401 of the Food and Drug Administration Modernization Act expired. Section 401 provided guidelines allowing the dissemination of information on unapproved uses of FDA-approved products.

While the new draft guidance answers this call, some individuals claim the language may be too simple, and that it has been released too quickly. Rep. Harry Waxman (D-CA), chairman of the House Oversight and Government Reform Committee, wrote FDA Commissioner Andrew von Eschenbach twice in the past few months, questioning the way in which the agency was pursuing the guidance. He said he had “significant concern” about the guidance proposal as it would “allow drug and device companies to use journal articles to promote potentially dangerous uses of drugs and medical devices without prior FDA review and approval.” Rep. Waxman and others also speculated that industry representatives have been pushing the agency to release the guidance, according to a Jan. 22 BusinessWeek article and other media reports.

Rep. Waxman has said that the rule would give pharmaceutical companies too much leeway with off-label use and marketing. Compared to Section 401, the draft guidance seems to allow for easier dissemination of articles on unapproved uses of drugs and may encourage companies to carry out fewer clinical studies.

Specifically, the draft guidance gives manufacturers just a few principles to follow when distributing scientific or medical journal reprints, articles, or reference publications. For example, the draft guidance calls for manufacturers to ensure that the article or reference be published by an organization that has an editorial board, and disclose any conflicts of interest for all authors or contributors to the article. In addition, articles should be peer-reviewed and published in accordance with specific procedures such as with a bibliography, but without any highlighting or summarizing by the manufacturer.

The draft guidance does warn against distribution of special supplements or publications “that have been funded by one or more of the manufacturers of the product in the article,” as well as against articles that are “not supported by credible medical evidence.”

FDA still has authority over whether or not a distributed article violates the Federal Food, Drug and Cosmetic Act.

Public comments on the draft guidance are due within 60 days of its appearance in the Federal Register (see Feb. 20 edition), to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

View the full 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 Devices.