Unapproved Uses Of FDA-approved Drugs And Medical Devices

The Food and Drug Administration (FDA) issued a preliminary draft guidance regarding the publication of information related to unapproved uses of FDA-approved drugs and medical devices.

Randall Lutter, FDA deputy commissioner for policy, said "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. This guidance also safeguards against off-label promotion."

Section 401 of the FDA Modernization Act had previously set out guidelines that permitted the dissemination of information on unapproved uses of FDA-approved drugs and medical devices. If the manufacturers complied with the guidelines when publishing information they were not seen as an attempt to promote the product for non-FDA approved use (off-label use). As Section 401 expired in September, 2006, new guidelines are needed. Hence the issue of the FDA's "Good Reprint Practice" draft guidance.

The draft guidance recommends principles drug/medical device manufacturers should follow when distributing scientific or medical journal reprints, or reference publications.

They should make sure that the article or reference was/is published by an organization which has an editorial board. All conflicts of interests faced by the organization, as well as biases for all authors, contributors or editors linked with the journal article should be disclosed fully. The article should be peer-reviewed and published in accordance with precise procedures.

Additionally, the draft recommends against distribution of special supplements or articles that have been financed by one or more of the manufacturers of the product in the article, and articles that are not supported by convincing medical evidence are considered false and misleading and should not be distributed.

The FDA will have the legal authority to decide whether an article/publication distribution be classed as promotion for an unapproved new use, or whether such activities cause a drug/medical device to be misbranded or adulterated under the Federal Food, Drug and Cosmetic Act.

The FDA is inviting typed comments, which should be submitted within 60 days of the Federal Register notice announcing the availability of the draft guidance.