White Guide and Orange Guide Formatting Project - Pfizer

Chapter 1o: STARTERS
Introduction
Orange Guide - Chapter 10: Starters
Pfizer provides healthcare professionals (HCPs) with free pharmaceutical drug product samples
(referred to as “starters”) to give to patients so that they can evaluate the efficacy and tolerability of
our products for the patient before filling a prescription. Starters also provide HCPs an opportunity to
become familiar with a drug and its properties, thereby enhancing their ability to make appropriate
prescribing decisions. The distribution of starters is highly regulated under federal and state law, and
the misuse of drug samples can have severe implications for both individual colleagues and Pfizer.
The Prescription Drug Marketing Act of 1987 (PDMA) is the key federal law governing the distribution
of drug samples. Pfizer policies for complying with the PDMA are described in the Starter Operations
Compliance Manual, and the key points are summarized in this Chapter. The distribution of starters is
also impacted by other healthcare laws such as those dealing with fraud and abuse and off-label
promotion.
In addition, several states have laws that affect whether and to whom starters may be distributed. For
example, some states have particular limitations on distributing starters for controlled substances like
Lyrica. Likewise, some states impose requirements (that differ from federal law) on when lost or stolen
starters must be reported, as well as which mid-level practitioners (e.g., nurse practitioners, physician
assistants) may prescribe drugs and are authorized to accept starters.
This Chapter summarizes certain key Pfizer policies regarding distribution of human
biopharmaceutical starters. Non-compliance with these policies puts the Company at risk and can
subject Pfizer colleagues to disciplinary action up to and including termination.
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