Comparative therapeutic claims of schedule 2 products in DTC setting
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If there are two randomized controlled trials that support a comparative therapeutic claim for a schedule 2 product (not for a schedule A condition), can the therapeutic claim be mentioned in the DTC setting (e.g., Product A was superior to Product B)?
This seems to be the case according to the "Data Requirements to Support Comparative Claims Related to Therapeutic Aspects of Nonprescription Drugs Used in Consumer-Directed Advertising and Labelling" section of the "Therapeutic Comparative Advertising: Directive and Guidance Document" but it's also a very confusing document and 20 years old, so I maybe misinterpreting the text?
This document also stipulates that "Statements that compare the side effect and safety profiles, of drug products or ingredients, may be made in consumer-directed advertising provided the general provisions of the Directive, this Guidance document and this section are met," is this the case for schedule 2 products?
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Hey @Username
“Schedule 2” is a bit broad. There are many factors and combinations to consider. Could you provide the product or therapeutic class, or Federal drug schedule (see link) to help narrow down the response. Alternatively, if you’re not comfortable sharing in a public space, you can email review@paab.
