Drug, device promotion may expand.
by Ault, Alicia
FDA last month proposed draft guidance that would allow drug and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"Good Reprint Practices" draft guidance states that the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."
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