Healthy Skepticism Library item: 12830

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Publication type: news

Silverman E.
FDA Issues New Rules For Journal Reprints
PharmaLot 2008 Feb 15
http://www.pharmalot.com/2008/02/fda-issues-new-rules-for-journal-reprints/

Full text:

The agency put out a draft guidance today called “Good Reprint Practices” for drugmakers as they grapple with distribution of medical and scientific journal that involve unapproved uses of drugs and devices.

In explaining the rationale behind the guidance, Randy Lutter, the FDA’s deputy commissioner for policy, says that “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,” he says in a statement. “This guidance also safeguards against off-label promotion.”

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 guidelines were met by manufacturers, disributing such materials wasn’t viewed by the FDA as evidence of an intent to promote the product for an “off-label” use. However, Section 401 expired on Sept. 30, 2006.

The draft guidance recommends principles manufacturers should follow when they distribute scientific or medical journal reprints, articles, or reference publications. These 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.

Three months ago, however, Henry Waxman, who chairs the House Oversight and Government Reform committee, lambasted the agency for issuing a guidance that he worried will open the door and allow manufacturers to promote “potentially dangerous uses” of drugs and devices without prior FDA review and approval. The proposal, he said at the time, would allow companies to “short-circuit” FDA review.

In addition, the draft guidance recommends against distribution of special supplements or publications that have been funded by one or more of the manufacturers of the product in the article,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 notes that it 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.