HCP eConsent Fax (no product mention) - Is this PAAB-exempt?
-
Hi There! I am currently developing an HCP eConsent fax and was wondering if this piece may be PAAB-exempt. The form is intended to be sent to HCPs requesting their consent to send them electronic communications about a certain disease area. There will be no mention of a specific product in this piece. There will be mention of a specific disease area and we would like to include the pharmaceutical company name and logo. I thought maybe this could be PAAB exempt? Any help is much appreciated.
-
In general, if material that is not linked to any product or has mention of any drug treatment, medication, pharmacotherapy or its equivalents (including but not limited to unmet needs, cellular drug targets, ongoing research, etc.), it may be exempt as it would not fall under the PAAB scope per code section 1.3.
As a reminder, per the Pre-NOC/Editorial communications guidance, even if pharmacotherapy is not discussed in the piece, pre-NOC Editorial pieces should be submitted to the PAAB for review as they relate to investigational drug research.
Should you be unsure if the fax meets exemption criteria, we suggest use of our opinion service to determine if it is exempt.
-
@jennifer-carroll Thank you this helps!