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'Intended Use' Rule: US FDA May Toss Its 'Totality Of Evidence' Standard

 
• By Brenda Sandburg

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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The pharmaceutical and medical device industries appear to be making headway in convincing the US FDA to narrow a final rule regarding the evidence the agency considers in determining how a manufacturer intends its product to be used, including whether it is intended for off-label use.

The agency announced that it is proposing to delay indefinitely the rule's implementation. FDA has already delayed implementing the rule twice before, first as part of the regulatory freeze announced...

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