The agency put out a draft guidance today called “Good Reprint Practices” for drugmakers as they grapple with distribution of medical and scientific journal reprints that involve unapproved uses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The draft guidance recommends principles manufacturers should follow when they distribute scientific or medical journal reprints, articles, or reference publications.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.

And today, Sid Wolfe of Public Citizen was equally harsh. The FDA announcement “contrasts the current recklessness of the agency with the more consumer-protective FDA of 10 years ago. In 1997, the FDA strongly opposed the principles in today’s guidance because they would have opened the door to the promotion of drugs for treatments for which there was not enough evidence that the benefits outweighed the risks.

“As a result, the law passed in 1997 - which was in place until October 2006 - required companies to submit medical journal articles in advance to the FDA and agree to file within three years a supplemental new drug application for the off-label use it wanted to promote. These safeguards will no longer be required under today’s proposal.”

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.