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FDA guidance offers potential for off-label usage

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ROCKVILLE, Md. The Food and Drug Administration on Friday potentially kept the door open for pharmaceutical manufacturers to detail doctors on off-label use of their products.

Specifically, the agency issued draft guidance on “Good Reprint Practices” for industry use in the distribution of medical or scientific journal articles and reference publications that involve unapproved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.

“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,” stated Randall Lutter, FDA deputy commissioner for policy. “This guidance also safeguards against off-label promotion.”

Once the practice is codified by the FDA, pharmaceutical manufacturers may be able to promote commonly-accepted, peer-reviewed off-label use of their medicines—which in turn could fuel sales of those products and increase the need for education among other healthcare professionals, such as pharmacists or nurse practitioners.

Critics of the proposal are afraid of just that—that pharmaceutical companies will promote off-label to help drive profits. Rep. Henry Waxman, D-Calif., worried that the proposed rule “caters to the industry’s desire to market their products without adequate testing or review” in an interview with the New York Times published Friday.

The Internal Medicine World Report in October published a report on off-label medicine use as a growing trend in the industry. The report included published studies that indicated Provigil, a medicine for sleep disorders, may show promise for bipolar depression; that statins don’t prevent prostate cancer; and that off-label use of the calcium-channel blocker verapamil, indicated for arrhythmias and high blood pressure, for the prevention of cluster headaches may lead to heart problems, among other studies.

Previously, Section 401 of the Food and Drug Administration Modernization Act set out guidelines that allowed the dissemination of information on unapproved uses of FDA-approved products. As long as the guidelines were met by the manufacturers, the dissemination of such materials was not viewed by the FDA as evidence of an intent to promote the product for an “off-label” use. However, Section 401 expired Sept. 30, 2006.

The FDA’s “Good Reprint Practices” draft guidance recommends principles manufacturers should follow when they distribute scientific or medical journal reprints, articles, or reference publications. Some of the principles include ensuring that the article or reference be published by an organization that has an editorial board. The organization also should fully disclose any conflicts of interest or biases for all authors, contributors or editors associated with the journal article. Articles should be peer-reviewed and published in accordance with specific procedures.

In addition, the draft guidance recommends against distribution of special supplements or publications that have been funded by one or more of the manufacturers of the product in the article, and articles that are not supported by credible medical evidence are considered false and misleading and should not be distributed.

The FDA 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 FDA is currently fielding public comments on the draft guidance.

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