'Off-Label' Communications That Are Still 'Consistent' With Labeling Get Better Defined
US FDA's final guidance provides more examples of data that meets the 'scientifically appropriate and statistically sound' standard.
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Regulatory experts note there has been an uptick in enforcement letters objecting to efficacy presentations in Rx drug promotions that are not consistent with FDA-required labeling. Panelists at FDLI meeting also discuss the use of real-world evidence in prescription drug promotion.
Sponsors needs to think carefully about what to say in product promotions when clinical benefit has not yet been demonstrated, legal and regulatory experts said; such communications may or may not be able to leverage US FDA guidances on ‘consistent with labeling’ (CFL) and scientific information on unapproved uses (SIUU).
In final rule describing the types of evidence the agency will consider in determining the ‘intended use’ of a product, FDA rejects industry requests to exclude ‘circumstances surrounding distribution’ and product design or composition.