On January 5, 2024, WLF filed a formal comment with the FDA in response to the agency’s latest revised draft guidance on the dissemination of published materials about off-label uses of medical products. Although the revised draft appropriately allows new forms of non-promotional communication—such as firm-generated presentations and clinical practice resources—WLF explains that it is still overbroad, ambiguous, and too restrictive. By chilling truthful, non-misleading scientific speech, the FDA’s revised draft threatens to undermine public health while disregarding the Constitution. Given its ambiguity, the revised draft also ignores the unreasonable burdens it imposes on countless drug and device manufacturers, who must rely on FDA’s guidance to ensure that their actions are lawful.
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