The concern of misbranded products leading to patient harm and potential fraud is inarguable.
Prescribing medicines off-label is a common practice, but with life science companies prohibited from sharing information about off-label uses, do physicians get the best available information to make sound clinical decisions?
Based on the Pharmaceutical Research and Manufacturers of America ("PhRMA") and the Biotechnology Innovation Organization ("BIO") principles, as well as the US Food and Drug Administration ("FDA") guidance, one thing is for sure - truthful and non-misleading communication will need to be supported by robust, comprehensive, and balanced scientific analysis.
In this article FRA's Jenny McVey will outline the industry's response to the continued lack of clarity around off-label communication and the long-awaited guidance from the FDA.
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