White Guide and Orange Guide Formatting Project - Pfizer

Key Points to Ensure Compliance (cont’d)
Orange Guide - Chapter 10: Starters
Starters may not be provided to HCPs for use in clinical trials, other research activities or for
distribution to patients in order to mitigate the cost of their treatment. HCPs seeking to assist
patients who cannot afford their medications should be referred to Pfizer Helpful Answers.
Starters may not be provided for charitable activities or an HCP’s other philanthropic
endeavors, nor may they be provided to missions or nonprofit organizations under any
circumstances.
Starters are not to be provided to HCPs for their personal use or taken by colleagues for their
personal use (“personal use” includes use by family or friends).
Any loss or theft of starters must be reported immediately to Starter Operations and the
responsible District Manager. Significant losses and thefts must be reported by Starter
Operations to the FDA within five days of a Pfizer colleague becoming aware of the loss or
theft and, if required, to the regulatory agency in the state in which the incident occurred.
Starter Allocation
A prescription drug starter sample is defined under the PDMA as a product unit that is packaged for
distribution to healthcare providers free of charge. Such items must be clearly labeled to reflect their
intended use and are intended to promote the sale of the drug. Off-label uses of a product should not
be considered for starter allocations. Although HCPs may prescribe our products for off-label uses, our
products cannot be promoted outside the approved labeling and therefore Pfizer may not knowingly
provide starters for such uses.
When Sales Colleagues distribute starters, they are engaging in product promotion. Leaving a starter
with an HCP implicitly delivers a message that the product is appropriate for its labeled use. When an
HCP implies or states that he or she is using a Pfizer product for an off-label use, providing starters to
that HCP for the off-label use may be considered off-label promotion and can subject Pfizer to
prosecution.
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Rev. 09/12
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