White Guide and Orange Guide Formatting Project - Pfizer
White Guide and Orange Guide Formatting Project - Pfizer
White Guide and Orange Guide Formatting Project - Pfizer
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<strong>Orange</strong> <strong>Guide</strong> – Chapter 16: Consumer <strong>and</strong> Employee Interactions<br />
Chapter 16: CONSUMER AND EMPLOYEE<br />
INTERACTIONS<br />
All colleagues must provide truthful, accurate <strong>and</strong> balanced product information to healthcare<br />
professionals (HCPs). It is equally important that you underst<strong>and</strong> the rules that govern your<br />
interactions with consumers (including patients, potential patients, <strong>and</strong> all other non-HCPs), as they are<br />
distinct from the rules that apply to your interactions with HCPs. Employees are consumers <strong>and</strong> must<br />
be treated according to the guidelines in this Chapter.<br />
<strong>Pfizer</strong> interacts with consumers at various types of events including speaker programs, health fairs,<br />
public screenings, <strong>and</strong> disease management programs. A variety of laws <strong>and</strong> industry st<strong>and</strong>ards<br />
specifically govern your promotional interactions with consumers. These are different from the laws<br />
<strong>and</strong> st<strong>and</strong>ards governing your promotional interactions <strong>and</strong> activities with HCPs. Like interactions with<br />
HCPs, however, interactions with consumers can involve promotional risks, including the following:<br />
The U.S. Department of Health <strong>and</strong> Human Services, Office of Inspector General (OIG) has<br />
warned that offering incentives, such as remuneration or free services, to consumers may<br />
implicate the federal anti-kickback laws.<br />
Some state attorneys general have interpreted state consumer protection laws to<br />
encompass off-label promotion.<br />
The Food <strong>and</strong> Drug Administration (FDA) has established stringent requirements regarding<br />
direct-to-consumer (DTC) communications.<br />
Furthermore, the Pharmaceutical Research <strong>and</strong> Manufacturers of America (PhRMA) has issued<br />
guidance to <strong>Pfizer</strong> <strong>and</strong> other member companies related to DTC advertising called Guiding Principles on<br />
Direct to Consumer Advertisements about Prescription Medicines – This document provides guidance on<br />
ways to ensure that DTC communications provide accurate, accessible <strong>and</strong> useful information to<br />
patients <strong>and</strong> consumers. <strong>Pfizer</strong> has committed to follow this guidance <strong>and</strong> has adopted its own<br />
Guidance for the Implementation of the Updated PhRMA DTC Principles.<br />
235<br />
Rev. 09/12<br />
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