White Guide and Orange Guide Formatting Project - Pfizer

Pfizer’s State Attorneys General Agreements
Orange Guide - Chapter 1: Overview and Key Principles
Pfizer has entered into written agreements directly with several state Attorneys General. Similar to the
CIAs, these agreements impose certain integrity obligations upon Pfizer. Because these agreements
are entered into with individual states, the obligations can and do vary among each agreement and
may be more restrictive than applicable law and the CIA. Generally, these agreements include
obligations related to promotional activities, incentive compensation, medical information, reprints
and physician payment posting. While some obligations exist only for a pre-specified time period,
many of the obligations do not expire. As applicable, obligations impacting Pfizer colleague activities
are implemented through new and updated policies and procedures governing the relevant activities.
For additional information regarding Pfizer’s State Attorneys General settlement agreements, please
visit the “State AG Agreements” page on the Corporate Compliance website.
Violations and Penalties
The OIG, the U.S. Department of Justice, the FDA, and state Attorneys General aggressively enforce
the anti-kickback and other laws and regulations discussed in this Overview. In addition to violating our
obligations under the existing CIA, any violation of law is subject to prosecution and potentially
punishable by a fine and/or imprisonment, as well as civil monetary penalties. Conviction under these
laws can also result in Pfizer’s exclusion from participation in federal and state healthcare programs, as
well as imprisonment of officers and/or employees responsible for each violation.
Failure to adhere to FDA advertising and promotion regulation, in particular, can result in a requirement
to run corrective advertising or “pre-clear” future promotional materials. Violations of the PDMA,
which can include failing to follow starter management requirements, may result in criminal sanctions,
including imprisonment.
Pfizer Compliance Program
Pfizer takes compliance with these laws and regulations very seriously and expects every colleague to
do the same. Taking compliance seriously includes taking prompt action to disclose potential violations
and cooperating with investigations of possible violations. Each colleague has a Duty to Act by
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