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Drug, device promotion may expand.


by Ault, Alicia
Skin & Allergy News • April, 2008 • Policy & Practice

FDA last month proposed draft guidance that would allow drug and medical device makers to distribute medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices. Drug and device makers had been allowed to disseminate such materials under guidelines set by the FDA, but that authority expired in September 2006. The FDA's new "Good Reprint Practices" draft guidance states that the article or reference should be published by an organization that has an editorial board and fully discloses conflicts of interest. In addition, articles should be peer reviewed, and manufacturers should not distribute special supplements or publications funded by product manufacturers. Rep. Henry Waxman (D-Calif.), chairman of the House Committee on Oversight and Government Reform, blasted the FDA for its proposal, which he said in a statement "is great news for the drug industry but terrible for the public health."


COPYRIGHT 2008 International Medical News Group Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
Copyright 2008 Gale, Cengage Learning. All rights reserved. Gale Group is a Thomson Corporation Company.
NOTE: All illustrations and photos have been removed from this article.


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