White Guide and Orange Guide Formatting Project - Pfizer

Pfizer’s Corporate Integrity Agreements
Orange Guide - Chapter 1: Overview and Key Principles
A Corporate Integrity Agreement (CIA) is a written agreement with the OIG that typically imposes
upon a company certain integrity obligations (e.g., training, reporting or audits) for a specified period of
time, generally five years from the date the CIA is executed.
Pfizer has entered into three CIAs as part of three settlements for alleged violations of federal
healthcare program requirements.
Lipitor CIA (2002): In 2002, Pfizer paid a $49 million fine and entered into a CIA for a term
of five years. The case involved a qui tam (whistleblower) suit filed by a Warner-Lambert
employee alleging that Pfizer provided $250,000 in undisclosed cash discounts (concealed
as “unrestricted educational grants”) to a managed care customer to get Lipitor on the
plan’s formulary. The government alleged that Pfizer underpaid Medicaid rebates as a result
of failing to properly calculate the “best price” for Lipitor.
Neurontin CIA (2004): In 2004, Pfizer paid a $429 million fine and entered into its second
five-year CIA. The case was also based upon a whistleblower suit filed by a former Warner-
Lambert employee alleging that Pfizer had engaged in off-label marketing to promote
Neurontin.
Bextra CIA (2009): In 2009, Pfizer entered into a five-year CIA as part of its settlement for
alleged violations of federal health care program requirements. As part of the settlement,
Pfizer paid $2.3 billion in fines. The case originated with eleven separate whistleblower
lawsuits that included allegations that Pfizer promoted Bextra for uses and in dosages that
the FDA did not approve. The CIA also settled alleged off-label promotional activities
concerning several other Pfizer products.
Under the 2009 CIA, Pfizer must annually report specific information to the OIG through December 31,
2014. Some of the CIA requirements are new, while others reflect policies that Pfizer already had in
place. Our obligations under the CIA include: (i) providing annual compliance training to most
U.S. personnel; (ii) disclosing activities by colleagues that are non-compliant with healthcare laws;
(iii) hiring an Independent Review Organization (IRO) to conduct annual reviews of certain Pfizer
systems, policies and processes; (iv) expanding certain transparency initiatives (such as posting
payments to HCPs); and (v) monitoring certain Field Force and Headquarters activities.
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