FDA Discourages "Negative Safety Claims" In Labels Even At The Risk Of Inconsistency
FDA does not generally allow any claims in labeling that a safety issue does not exist with the product "because the evidence to support a conclusion of 'no effect' is very difficult to generate," the agency said. It's a policy that some academics say creates confusion, though.
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FDA is careful to exclude phrasing from labeling that might allow a product to claim a safety advantage if it is not definitively proven, but the agency is less strict about using the term "safer" outside the labeling context.
Bayer's newly approved gadolinium-based contrast agent only needs half the dose of other such products. The label eschews comparative safety claims.
But the sponsor will have to convince an FDA advisory committee that the drug's unusual dosing will not cause medication errors in a crowded class.