White Guide and Orange Guide Formatting Project - Pfizer

Orange Guide – Chapter 2: Detailing to HCPs
Q. Am I permitted to use a non-Pfizer e-mail account, or a non-Pfizer device with
texting capabilities or other social networking tool (e.g., Google®, Yahoo® or
Facebook®), to interact with HCPs or other customers regarding Pfizer
business?
A. No. You may only use your Pfizer e-mail account or a Pfizer-issued device to
communicate with customers regarding Pfizer business.
Stay On-Label and Discuss Only Approved Products and Indications
Pfizer may only promote FDA-approved products and FDA-approved uses and dosing of its products.
All promotional statements made about a drug must be consistent with the product’s labeling and must
be based on the information contained in RC-approved materials. Off-label promotion is taken very
seriously by Pfizer and the government. In fact, Pfizer is obligated under a Corporate Integrity
Agreement (CIA) to proactively report instances of off-label promotion to the U.S. Department of
Health and Human Services, Office of Inspector General (OIG).
Uses or indications that have not been approved, that remain under investigation, or that are under
FDA review are considered off-label and may not be discussed. Pre-approval promotion can jeopardize
the approval of a new product or indication and may result in severe penalties. Therefore, Pfizer policy
mandates that you discuss only approved products, indications and dosing in accordance with RC-
approved promotional materials, including any applicable product Implementation Guides. No matter
how appealing or robust the scientific evidence, you cannot discuss any product or indication with
customers until it is approved by the FDA.
If an HCP asks an unsolicited question about an unapproved product or unapproved indication, you
must refer the question to Pfizer's Medical Information Department. Colleagues using an iCUE tablet
must submit any such questions using the iCUE system. You may also provide the HCP with USMI’s
phone number and website address to enable the HCP to contact USMI directly. You may not
otherwise facilitate any USMI request.
Critical to staying on-label is making sure that the right discussions and activities are taking place with
the right HCPs. Therefore, you must make a good faith effort to avoid presenting product information
to, or otherwise engaging in promotion with, HCPs who are excluded for the product you are
promoting. This means you must not detail, provide starters, vouchers, co-pay cards, educational
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