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118 - Under what circumstances would it be acceptable to use a peer-reviewed, published study for a schedule F drug if that study uses a dosing regimen for the companion drug (always prescribed together but not subject of advertising, nor manufactured by the same company) that is inconsistent with the product monograph?
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Advertising must be consistent with the sponsor product's Terms of Market Authorization as per Food and Drugs Act section 9.1 and PAAB code section 3.1. As such, products promoted for use in combination with the sponsor's drug should be within the sponsor's product monograph (PM). Additionally, the dosing of that combined drug should be consistent with the PM. Please call the PAAB office if you would like an opinion on your specific case.
