Skip to content
  • Categories
  • Recent
  • Tags
  • Popular
  • Users
  • Groups
Skins
  • Light
  • Cerulean
  • Cosmo
  • Flatly
  • Journal
  • Litera
  • Lumen
  • Lux
  • Materia
  • Minty
  • Morph
  • Pulse
  • Sandstone
  • Simplex
  • Sketchy
  • Spacelab
  • United
  • Yeti
  • Zephyr
  • Dark
  • Cyborg
  • Darkly
  • Quartz
  • Slate
  • Solar
  • Superhero
  • Vapor

  • Default (No Skin)
  • No Skin
Collapse
Brand Logo

Forum

  1. Home
  2. PAAB Q&A
  3. FYI post-approval change/preclearance exemption/what requires review/PAAB scope
  4. 155 - In the PAAB code 1.5, you note a few examples of what would qualify as PAAB exempt. Working within the parameters of drug name only not linked to therapeutic message, would saying that your brand has "no generic equivalent" be appropriate?
PAAB Notice
The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB), including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.

155 - In the PAAB code 1.5, you note a few examples of what would qualify as PAAB exempt. Working within the parameters of drug name only not linked to therapeutic message, would saying that your brand has "no generic equivalent" be appropriate?

Scheduled Pinned Locked Moved FYI post-approval change/preclearance exemption/what requires review/PAAB scope
1 Posts 1 Posters 270 Views
  • Oldest to Newest
  • Newest to Oldest
  • Most Votes
Reply
  • Reply as topic
Log in to reply
This topic has been deleted. Only users with topic management privileges can see it.
  • Jennifer CarrollJ Offline
    Jennifer CarrollJ Offline
    Jennifer Carroll
    wrote on last edited by
    #1

    Section 1.5 exemption from pre-clearance review needs to meet BOTH of the following requirements: The ad contains only the drug name The ad is not linked to a therapeutic message in any way (e.g. the ad does not appear in proximity to an article on a disease for which the product is indicated) The intent of section 1.5 is to allow for the expedient communication of non-comparative, commercial messages. These include changes in availability, price and formulary coverage. Please note that while these items may be exempt from PAAB review, they may still be defined as "advertising" according to the Food & Drugs Act and therefore should adhere to the principles of the PAAB Code. With respect to your specific question, the proposed claim, "no generic equivalent", neither meets the first criteria listed above nor does does it match the examples listed in the explanatory notes. In addition, it is inherently comparative in that it refers to competitors (or lack thereof). Therefore, the claim is not exempt from PAAB review. Please call the PAAB office if you have any questions.

    1 Reply Last reply
    0
    Reply
    • Reply as topic
    Log in to reply
    • Oldest to Newest
    • Newest to Oldest
    • Most Votes


    • Login

    • Don't have an account? Register

    • Login or register to search.
    • First post
      Last post
    0
    • Categories
    • Recent
    • Tags
    • Popular
    • Users
    • Groups