If we are to build a Veeva Approved Email, which will be sent out by Sales reps to HCPs, which speaks to our PSP, it is possible to include patient feedback that we have received in this email? Patients will not be identified, only quotes regarding their experience will be included.
Please note there will be no product claims. None of the patient feedback will speak to the product, it will only speak to their experience with the PSP.
Hi there, it is my understanding that manufacturers can provide HCPs with branded patient brochures that the HCP can then choose to share with a patient once they have been prescribed. In this case, the primary audience of the brochure is the HCP and the patient. However, if we were to provide a brochure holder (very simple with just product and company logos) with this branded patient brochure, would there now be a secondary audience for this brochure (i.e., healthcare consumers)?
@jennifer-carroll Hi Jennifer, thank you for your response. If the material meets the criteria in the Distinction Document, can you confirm that the HCP prescriber can provide the one pager to patients that have already been prescribed the drug? Would it exempt from PAAB pre-clearance if this is the case?
We are looking into developing a one pager that contains information on a observational study that is being conducted, and it will be provided to patients that have been prescribed the product by an HCP. This piece will not be promotional in content and is mainly intended to provide the patient with information on the type of study, its purpose and what the patient's involvement in the study, should they choose to participate, will look like. Would a material like this be subject to PAAB preclearance?
