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FDA guidance for off-label use criticised
  18 February 2008
A draft guidance issued by US regulators about the ways in which drugmakers can distribute medical and scientific journal articles that involve off-label uses for approved products has stirred up controversy.
The US Food and Drug Administration's deputy commissioner for policy, Randall Lutter, said that articles that discuss unapproved uses of agency-approved drugs and devices "can contribute to the practice of medicine and may even constitute a medically recognised standard of care". However he also claImed that the guidance "also safeguards against off-label promotion".
The FDA's 'Good Reprint Practices' draft guidance recommends principles manufacturers should follow, such as ensuring that the article or reference "be published by an organisation that has an editorial board". The organisation also should fully disclose any conflicts of interest or biases for all authors, contributors or editors associated with the journal article. Articles should also be peer-reviewed and published in accordance with specific procedures, the FDA added.
In addition, the draft guidance recommends against "distribution of special supplements or publications that have been funded by one or more of the manufacturers of the product in the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". The FDA is accepting comments from the public on its proposal for 60 days.
The agency can certainly expect one from Sidney Wolfe, director of the Health Research Group at influential consumer body Public Citizen. He said that the decision to once again permit the promotion of off-label uses of drugs "contrasts the current recklessness of the agency with the more consumer-protective FDA of 10 years ago".
In 1997, Dr Wolfe said, the FDA strongly opposed the principles in the latest 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", he added.
Dr Wolfe concluded by saying that "almost every week brings new evidence of the FDA's dangerous attitude about the public's health and demands a change in leadership at the agency, starting with the commissioner".
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