'Intended Use' Rule: US FDA May Toss Its 'Totality Of Evidence' Standard
Pharma and device industries had complained that rule is overbroad, violates the First Amendment and would increase company exposure to liability.
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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.
US FDA is considering calls to drop 'totality of circumstances' test and to clarify that mere knowledge of unapproved use does not constitute evidence the use was intended.
Trade groups say final rule would allow any activity to be considered evidence of a manufacturer’s intended use of a product and increase exposure to potential liability.