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.
Remote Workshop 2020 series
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Comparative therapeutic claims of schedule 2 products in DTC setting -
Comparative therapeutic claims of schedule 2 products in DTC settingIf 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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Pre-NOC storyboard reviewHello @Jennifer-Thomson
It sounds like this would fall under a PILOT: Administrative Guideline for the Review of Pre-NOC Advertising Submissions. We’d get the file to “no further comments” pending review of the layout (video) post NOC. Please reach out to admin to discuss the specifics so that we can ensure we’re understanding the request and facilitating the best possible pathway to approval. -
RAMQ criteria vs. notesHey @ALee
The same approach of “where applicable” should be applied to the RAMQ coverage as well. The intent of the inclusion is to ensure that the user is clear about the criteria for coverage as outlined by RAMQ. If the definitions and notes clarify or set the limitations/context for interpretation, they should be included. -
RAMQ criteria vs. notesThe Advisory on Provincial Formulary Statements distinguishes 'reimbursement criteria' from 'definitions and notes'. Per the RAMQ Advisory, coverage claims must be accompanied by 'reimbursement criteria'. Can you please confirm if the 'definitions and notes' portion of the RAMQ listings are required to appear in APS? These usually deal with initial authorizations and continuing requests, and are not technically criteria.
