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FDA Releases Draft Guidance On Use of Scientific and Medical Literature for Drug Promotion

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The new FDA guidance on the use of scientific and medical literature to promote drug products enters a grey area between upholding the First Amendment right to free speech and ensuring drug safety. The FDA already regulates company-sponsored or generated studies that include information that has not been specifically approved by the FDA or fail to meet scientific standards. However, when rigorously-conducted, independent studies that are driven by scientific rather than promotional purposes recommend drug uses that are not approved by the FDA, should companies be allowed to distribute them? The FDA’s guidance outlines what qualifies as independent and scientifically sound literature, and what sort of disclosures companies should include when distributing such literature.



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