FDA Publishes Revised Guidance on Reprint Practices for Off-Label Drugs and Medical Devices

The Food and Drug Administration this month issued draft guidance that clarifies for drug and medical device makers recommended practices for distributing information that discuss the off-label uses of approved drugs or medical devices.

The draft guidance, issued March 3, would replace final guidance published in January 2009 that set forth FDA's thinking at the time on what information drug and medical device companies may provide—such as scientific or medical journal articles—to health care professionals or health care entities that discuss unapproved uses for FDA-approved drug and medical devices.

In July 2011 and September 2013, the FDA received citizen petitions filed on behalf of numerous drug and medical device makers that included several requests related to FDA's approach to the distribution of scientific and medical information reflecting unapproved uses. “FDA continues to consider the specific requests made in the citizen petitions, which include requests for issuance or revision of regulations, and has not yet reached a final determination on those petitions,” the FDA stated.

In its notice, the FDA estimated that about 400 drug and medical device companies distribute scientific and medical publications that discuss unapproved new uses for FDA-approved products.

Certain Criteria

The latest draft guidance would provide recommendations on the specific characteristics of scientific and medical publications that companies may opt to distribute, the FDA said. These characteristics include, for example, that the publications “be from journals, scientific or medical reference texts, and clinical practice guidelines that are produced by independent sources and meet criteria for professional/peer review; be based on specified types of scientific evidence; and be complete, unabridged, and without highlighting or characterization by the manufacturer.”

The draft guidance recommends that the information be accompanied by a “prominently displayed and permanently affixed statement” disclosing that some, or all, uses of the manufacturer's drugs or devices described in the information have not been approved by the FDA.

The information also must include any disclosure where the author of the article may have a financial interest in the drug or medical device maker, or where the author is receiving compensation from that drug or medical device maker. The FDA draft guidance also recommends that the drug or medical device maker disclose all significant risks or safety concerns associated with the unapproved uses.

The FDA is currently soliciting public comment on the draft guidance. Electronic or written comments are due by May 2.