PhRMA, BIO Petition FDA to Narrow Scope of New Intended Use Standard

PhRMA and BIO are calling on the FDA not to impose a new standard for determining the intended use of a drug that the trade groups say could broaden the scope of the agency’s oversight of off-label promotions.

In January, the FDA released a final rule that would allow the agency to consider the “totality of evidence” when determining the intended use of the drug. Under this standard, the FDA could use non-promotional scientific exchanges, sales forecasts and production scale-ups as evidence of off-label communication in order to take enforcement actions against manufacturers.

The trade groups argue there is no support in existing law for the totality standard.