White Guide and Orange Guide Formatting Project - Pfizer

Orange Guide - Chapter 1: Overview and Key Principles
Providing a gift to a retail or wholesale customer to influence the purchase of
pharmaceutical products;
Providing an educational or research grant to a managed care organization to influence the
formulary position of a product; and
Paying for the services (e.g., consulting services) of an HCP or other customer at a fee above
the reasonable, fair market value for such services.
Fair Market Value: Price at which an asset or service passes from a willing seller to a willing buyer
based on market demand and supply. Pfizer is required to pay HCPs fair market value compensation
for speaking and consulting services.
Pfizer treats all HCPs and other customers as if they are subject to the anti-kickback laws, even though
they may not participate in government healthcare programs.
Safe Harbors from the Federal Anti-Kickback Statute
The federal anti-kickback statute is so broad that, if read literally, it could restrict many otherwise
legitimate marketing activities and even some non-promotional activities. Recognizing this, the U.S.
Department of Health and Human Services (HHS), Office of Inspector General (OIG) has defined
certain “safe harbors”. Activities that fall entirely within a safe harbor, such as legitimate service
arrangements, do not violate the anti-kickback statute.
HHS: Federal administrative agency that oversees Medicaid, Medicare and other federally funded
healthcare programs.
OIG: A legal department within HHS charged with enforcing federal healthcare laws and regulations
and negotiating and overseeing Corporate Integrity Agreements.
A number of safe harbors are relevant to our business activities, but three are especially important:
Discount safe harbor: allows Pfizer to discount the price of a product to make it competitive
with other products, provided that the discount is properly reported to the government and
complies with other safe harbor requirements.
Managed Care safe harbor: permits Pfizer to provide a wide array of discounted items or
services to certain eligible managed care organizations under specified circumstances.
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