Off-Label Use: US FDA Backs Away From ‘Totality Of Evidence’ Standard In Proposed Reg

 
• By Brenda Sandburg
  
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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.

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FDA proposed rule clarifies how agency determines a company's intended use of a medical product • Source: Shutterstock

The US Food and Drug Administration has made concessions to the biopharma industry in a new proposed rule describing the types of evidence it will consider in determining a medical product’s intended use. The new reg would drop the “totality of evidence” standard and specify that a manufacturer’s knowledge alone about an unapproved use of a product does not mean the firm intended it for that use.

However, the proposed rule also provides examples of the evidence the agency will consider in determining if a manufacturer intended...

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