‘Intended Use’ Rule: Industry Urges US FDA To Revoke ‘Totality Of Evidence’ Standard

A final rule FDA issued in January has shaken industry groups who say it creates a new legal standard for assessing a manufacturer’s “intended use” of a product that will allow any evidence to be used to bring a criminal misbranding action – thus exposing companies to potential liability for normal business activity.

Revisions to the “intended uses” regulations were included in a final rule on tobacco-derived products. “If the totality of evidence establishes that a manufacturer objectively intends that a drug introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which it is approved (if any),” he must provide adequate labeling about those uses, the final rule states