When are co-pay APS subject to PAAB review?
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We are creating separate HCP and patient branded co-pay announcement APS. The content on the HCP co-pay APS is:
- Logo and brand name
- Message that co-pay is available for patients prescribed [brand name]
- Instructions for HCPs to register patients
- Link to the co-pay portal (co-pay portal is run by a third party and the manufacturer has no control over the portal)
The content in the patient co-pay APS is:
- Logo and brand name
- How to use their co-pay card
Are the above 2 APS scenarios considered PAAB-exempt if we do not include the indication for [brand name]? If not, can you clarify what about this content subjects these APS to PAAB review?
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We are creating separate HCP and patient branded co-pay announcement APS. The content on the HCP co-pay APS is:
- Logo and brand name
- Message that co-pay is available for patients prescribed [brand name]
- Instructions for HCPs to register patients
- Link to the co-pay portal (co-pay portal is run by a third party and the manufacturer has no control over the portal)
The content in the patient co-pay APS is:
- Logo and brand name
- How to use their co-pay card
Are the above 2 APS scenarios considered PAAB-exempt if we do not include the indication for [brand name]? If not, can you clarify what about this content subjects these APS to PAAB review?
Hey @mimic909
This is a specific review question about specific pieces. It should be submitted for an opinion. You can request an opinion for exemption with a note that you’d like to proceed to review if not exempt, as per the PAAB Policy and Procedure for Reviewing Exemption Request eFiles.
As general guiding principles, when you direct branded advertising to HCPs or branded patient information to patients through HCPs, it is subject to the PAAB Code and all other advertising regulations. This also applies to APS that promote a corporate service (e.g. co-payment) (s7.4).
Payment to a site to include your brand in their space is “control” as the brand would not exist there without the sponsors interaction. While you may not control the copy in this space, it is still the manufacturers responsibility to ensure it meets advertising regulations.
