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