Off-Label Use Final Rule: US FDA Declines To Focus Solely On Promotional Claims
In final rule describing the types of evidence the agency will consider in determining the ‘intended use’ of a product, FDA rejects industry requests to exclude ‘circumstances surrounding distribution’ and product design or composition.
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The FDA's revised draft guidance on scientific communications to health care providers about unapproved uses of products describes the studies that are likely to be scientifically sound and clinically relevant. The agency also gives recommendations on presenting off-label information on web pages and in exhibit halls.
PhRMA and Pfizer attorneys criticize the rule’s broad evidence standard, lack of safe harbors, and disregard of the First Amendment. Opposition to the rule is expected to continue to play out in lawsuits.
New proposed rule says a manufacturer’s knowledge of the unapproved use of a product does not alone determine intended use. Former FDA lawyer says rule could set off fireworks over the scope of what the agency considers evidence of off-label use.