White Guide and Orange Guide Formatting Project - Pfizer

Orange Guide - Chapter 1: Overview and Key Principles
reporting best price, paying kickbacks to healthcare providers, and encouraging physicians to seek
reimbursement from the government for free samples of prescription drug products.
The government also has utilized the FCA to combat instances of off-label promotion. Under this
reasoning, when a pharmaceutical company engages in off-label marketing, the company puts into
motion a series of events in which a prescription will be reimbursed by a government program even
though it was not eligible for reimbursement (e.g., physician writes a prescription for an off-label use,
pharmacist fills the prescription, pharmacist then seeks reimbursement for the off-label prescription).
In so doing, it has been argued by the government that the pharmaceutical company has “induced”
another party to submit a false claim, resulting in a violation by the pharmaceutical company. Sales
Colleagues must ensure that all HCP interactions comply with Orange Guide Chapter 2: Detailing to
HCPs. All other colleagues must ensure that marketing materials and other commercial activities
comply with White Guide Chapter 2: Advertising and Promotional Materials and White Guide Chapter 3:
Promotional Interactions with Healthcare Professionals.
Privacy Laws
Pfizer and firms engaged by us to perform various services (e.g., advertising and promotion agencies
and other vendors) might collect and process various types of personal information (e.g., healthcare
data), and colleagues may encounter sensitive personal information in the course of their visits to meet
with HCPs. Colleagues are responsible for ensuring that the data is handled carefully and in compliance
with Pfizer’s policies and applicable federal and state privacy laws and regulations.
For more information about your obligations to maintain patient privacy, see the Privacy chapter.
State Consumer Protection Laws
Many states have laws that seek to protect consumers from inappropriate marketing and sales
practices. For example, virtually all states have broad laws prohibiting “unfair” or “deceptive” trade
practices. Some state Attorneys General further contend that state consumer protection laws
encompass off-label promotion. You should direct any questions regarding state consumer protection
laws and their impact on your activities to your team attorney.
10
Rev. 09/12
Page 10 of 15