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FDA proposes draft guidance on literature regarding unapproved uses

Device Regulation Alert: Safety, Compliance and Reimbursement News, March 3, 2008

The FDA released new draft guidance addressing industry distribution of articles discussing unapproved uses of devices, drugs, and biologics in the February 20 Federal Register. Comments on the draft must be submitted by April 21, 2008.

Section 401 of the Food and Drug Administration Modernization Act of 1997 previously described when device, drug, and biologic manufacturers could provide healthcare professionals with literature about unapproved uses. Section 401 expired in 2006.

Recognizing the value of this literature to the medical community, the FDA offers this draft guidance sharing its recommendations for how the industry can distribute such information without being sanctioned for promoting off-label use.

The guidance recommends that any literature about unapproved uses:

• Should be published subject to oversight of an editorial board
• Include disclosure of conflicts of interests among authors, editors, and contributors
• Be peer-reviewed and subject to other procedures
• Should not be sponsored publications or otherwise commissioned or edited by device manufacturers
• Be generally available through independent sources
• Be supported by credible medical evidence

Additionally, the article can't be contrary to credible evidence from clinical investigations or have been withdrawn or disclaimed by the publication or author. It also can't pose a risk to public health.

In addition, the FDA stated manufacturers:

• Shouldn't edit, highlight, or mark the literature
• Should include the approved labeling for the device and
• Should disseminate the literature separately from any promotional communications
• Should also attach a statement that the literature discusses uses not approved or cleared by the FDA

The FDA still has authority to decide on a case-by-case basis whether distributing such materials goes too far and qualifies as misbranding or adulterating a device under the Federal Food, Drug, and Cosmetic Act.

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