White Guide and Orange Guide Formatting Project - Pfizer

Inclusion of Materials with Starters
Orange Guide - Chapter 10: Starters
Provided that starter product packaging remains intact, starters may be offered in kits that include
PhRMA Code compliant educational items, such as patient journals or other disease state educational
booklets. Starter kits may also include co-pay coupons, co-pay cards, savings cards and other similar
offerings to consumers for the specific starter product.
Before such materials are distributed in a starter kit (or independent of the starters), they must be
reviewed and approved by the applicable RC. When presenting such items for review, the RC team
must be advised that the items will accompany starters as part of a starter kit or other promotional
program. Like all promotional items, materials included in Pfizer starter kits must be factually accurate
and must not be misleading in any respect. All promotional statements made about a Pfizer product
must be consistent with the information contained in the product’s approved package insert and/or in
an approved promotional piece. These additional materials must be submitted to the FDA at the time
of first use.
As with any promotional materials, Sales Colleagues may not alter these additional materials in any
way or add their own promotional materials to them.
Adding Materials to Starter Packages
Q. Can a Sales Colleague insert RC-approved promotional items such as a packet
of co-pay cards or vouchers into a starter package for the relevant product?
A. No. Promotional materials must be specifically approved by RC for distribution
as part of a starter package. If a Sales Colleague independently adds materials
to a starter package – even though those materials are themselves RCapproved
– it could constitute an impermissible alteration of the starter
packaging.
Distribution of Starters to Approved Recipients
Detailed procedures for starter accountability and compliance are set forth in the Starter Operations
Compliance Manual. Sales Colleagues and other colleagues involved directly in starter distribution
should be familiar with the policies and procedures set forth in this manual.
183
Rev. 09/12
Page 7 of 17