215 - Dear PAAB Can a sales rep distribute a patient booklet that has been independently created by patient group? Can they distribute the booklet if their company sponsored the creation of the booklet? Many thanks.
Jennifer Carroll last edited by
I presume the booklet is distributed by reps to HCPs (and the HCPs then distribute to the patient). Reps should not be distributing content to patients. With this understanding, the answer is yes. BUT, please note that the piece requires PAAB review if the manufacturer had any influence over content creation. Examples of "influence" include (but are not limited to): detailed direction on content or scope of research, review privileges, selection of writer...