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. Patient Info
  4. FB on PSP Enrolment Forms
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.

FB on PSP Enrolment Forms

Scheduled Pinned Locked Moved Patient Info
2 Posts 2 Posters 704 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.
  • K Offline
    K Offline
    kshulist
    wrote on last edited by
    #1

    How come patient support program enrolment forms do not require the indication / low-level fair balance? They usually link the drug to the therapeutic use in a "diagnosis" section.

    Jennifer CarrollJ 1 Reply Last reply
    0
    • K kshulist

      How come patient support program enrolment forms do not require the indication / low-level fair balance? They usually link the drug to the therapeutic use in a "diagnosis" section.

      Jennifer CarrollJ Offline
      Jennifer CarrollJ Offline
      Jennifer Carroll
      wrote on last edited by
      #2

      Hello @kshulist

      Enrolling a patient in a support program means that the decision to prescribe the product has already been made (i.e. patient is on the drug). Additionally, given the type of information on the form (e.g., including dosing or monitoring info), the form is not considered promotional but rather administrative in nature. Given these two reasons, indication/FB is typically not required. However, should promotional messaging be added (in the context of an HCP completed PSP enrolment form), indication and fair balance would indeed be required. For a patient completed enrolment form, no promotional messages would be acceptable and therefore the form would be administrative.

      1 Reply Last reply
      1
      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