White Guide and Orange Guide Formatting Project - Pfizer

Orange Guide – Chapter 7: P&T Committee Interactions
determining the appropriate content of the presentation (and the identity of the Pfizer colleague
presenting) turns on who requested the formulary presentation—Pfizer or the P&T Committee.
If Pfizer Requested the Opportunity to Present Information
When Pfizer asks for the opportunity to present information, the presentation is promotional and the
FDA rules surrounding product promotion apply. Accordingly, any colleague (including a Medical
Colleague) that presents information in this situation must abide by the four Core Compliance
Principles:
Use only RC-approved materials and selling statements;
Stay on-label and discuss only approved products and indications;
Provide an accurate and balanced presentation; and
Never engage in actual or perceived quid pro quo.
Each Pfizer product team is responsible for creating and maintaining a slide deck that is appropriate for
use during formulary presentations. Only these and other RC-approved materials can be used when
Pfizer has requested the opportunity to present information. If you would like to add slides to the slide
deck, the slides must be approved by the appropriate Pfizer Review Committee before use. When
proactively providing product information, colleagues must never include information about off-label
uses, including efficacy or safety information that conflicts with the approved labeling. Colleagues
must never include new clinical data that has not yet been approved for product promotion in the
presentation materials. If a P&T Committee makes a specific unsolicited request for off-label
information during the presentation, only Medical Colleagues (or a Headquarters approved physician
consultant) may respond to the request in accordance with the guidelines set out for them (i.e., the
Medical Colleague must acknowledge that the information is off-label; provide a brief answer which is
truthful, not misleading, based on substantial scientific evidence and non-promotional in tone; and
then continue with the original presentation). Non-medical Colleagues may remain in the meeting
during this time, but if a more extensive answer or discussion is needed to respond to the customer’s
request, the Medical Colleague should speak to the customer after the meeting without the presence of
Non-Medical Colleagues.
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