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

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 an