White Guide and Orange Guide Formatting Project - Pfizer

Orange Guide - Chapter 1: Overview and Key Principles
criminal prosecution. Drug samples could be considered “remuneration” under the anti-kickback laws if
given to an HCP for the wrong reason. Starters should never be distributed to personally benefit an
HCP or to induce an HCP to prescribe our products, as prescription decisions should be based solely on
patient need.
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 and
some have requirements on when starters that were lost or stolen must be reported. Moreover, states
have various approaches to which HCPs (e.g., nurse practitioners, physician assistants) may prescribe
drugs and therefore are authorized to accept starters. For more information on how to develop a
compliant starter strategy, see the Starters chapter.
State Pharmaceutical Compliance and Disclosure Laws
In addition to the federal government, a growing number of states are regulating pharmaceutical
companies’ interactions with HCPs. These laws and regulations include restrictions and sometimes
prohibitions on gifts and meals, disclosure of payments made to HCPs, and reporting of data such as
Average Manufacturing Price and Best Price. Some of these restrictions may even extend to
interactions that occur outside of the geographic boundaries of the state that enacted the law or
regulation.
For more information on whether your activities are implicated by state pharmaceutical compliance
and disclosure laws, see the Chapter on State Gift Restriction and Disclosure Laws, and the Chapter on
Meals, Educational Items, and HCP Payment Disclosure.
Overview of Other Key Laws and Regulations
False Claims Act
The False Claims Act (FCA) prohibits entities and individuals from submitting, or inducing another to
submit a false claim for reimbursement from the federal government. For example, the federal
government has used the FCA to investigate and prosecute pharmaceutical companies for falsely
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