White Guide and Orange Guide Formatting Project - Pfizer

Orange Guide - Chapter 1: Overview and Key Principles
informing HCPs about the benefits and risks of medicines to help enhance patient care. The PhRMA
Code principles are embedded in the policies throughout this Guide.
The PhRMA Code, as well as updated Frequently Asked Questions, can be viewed under the
Compliance tab on PfieldNet at http://pfieldnet.pfizer.com/Compliance/Pages/Home.aspx and on
OpSource at http://opsource.pfizer.com/Pages/PhRMAHCPHome.aspx.
PhRMA Guiding Principles – Direct To Consumer Advertisements About Prescription Medicines
In 2009, PhRMA adopted its updated Guidance for the Implementation of the Updated PhRMA DTC
Principles. These Principles guide the industry’s use of DTC advertising to communicate information
about disease states and potential treatments so that patients can make informed choices. PhRMA’s
Guiding DTC Principles go beyond legal obligations to set forth a method of communicating that will
enable DTC communications to serve to educate patients and consumers and encourage them to seek
guidance from their healthcare professionals. Pfizer has adopted its Guidance for the Implementation
of the Updated PhRMA DTC Principles which must be followed when developing DTC advertising.
When developing DTC advertising, Marketing Colleagues must also adhere to the policies set forth in
White Guide Chapter 2: Advertising & Promotional Materials.
OIG Compliance Program Guidance for Pharmaceutical Manufacturers
In 2003, the OIG issued its Compliance Program Guidance for Pharmaceutical Manufacturers, which
sets forth its general views on the value and fundamental principles of compliance programs for
pharmaceutical companies and the specific elements that pharmaceutical companies should consider
when developing and implementing an effective compliance program. The Guidance states the
following seven elements are recognized as fundamental to an effective compliance program:
(1) Implementing written policies and procedures; (2) Designating a compliance officer and compliance
committee; (3) Conducting effective training and education; (4) Developing effective lines of
communication; (5) Conducting internal monitoring and auditing; (6) Enforcing standards through
well-publicized disciplinary guidelines; and (7) Responding promptly to detected problems and
undertaking corrective action. All seven elements are embedded in Pfizer’s compliance program.
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