45 - Can peer reviewed journal article reprints be distributed by sales reps or sent by direct mail if they contain off-label discussion of a drug? What about textbooks purchased from a publisher (no development involvement by the pharma company)?
Jennifer Carroll last edited by
No. While published peer-reviewed journals do not require PAAB preclearance review they must meet "advertising" requirements if the purpose of the unsolicited distribution is to promote the sale of a healthcare product. To decide that we would look at the content of the reprint. If there is emphasis on a product of the sponsor of the distribution in the reprint, distributed either by rep or mail, then it would most likely be seen as advertising. Off-label promotion is in contravention of the Food and Drugs Act so all statements in the reprint should also be seen in the approved product monograph. Independently published textbooks with no emphasis on the sponsor's products are not considered to be advertising when they are distributed in their whole with no promotional elements attached. If the book was mostly about the sponsor's healthcare product, it would be considered advertising and off-label statements would not be allowed.