FDA would expand Promotion.

The FDA last month proposed guidance to let drug and medical device makers distribute medical or scientific journal articles and reference publications on unapproved uses of their products. 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" proposal requires the article or reference to 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, or articles not supported by credible medical evidence. Rep. Henry Waxman (D-Calif.), chairman of the House Committee on Oversight and Government Reform, blasted the proposal, which he said in a statement "is great news for the drug industry but terrible for the public health."