White Guide and Orange Guide Formatting Project - Pfizer

Orange Guide – Chapter 6: Clinical Research and Investigator-Initiated Research
experience and training. Compensation will be based on the value of the research services provided.
Pfizer’s reason to support an HCP’s medical research must never be to:
Establish or improve Pfizer’s relationship with the HCP;
Gain or improve access to the HCP;
Reward past prescribing or induce future prescribing; or
Influence formulary decision making.
Payments to HCPs may violate federal or state anti-kickback laws if such payments are made to reward
or influence the recipient’s prescribing practices or to establish or improve Pfizer’s relationship with an
HCP. In addition, both the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on
Interactions with Healthcare Professionals (PhRMA Code), and the U.S. Department of Health and
Human Services, Office of Inspector General (OIG) Compliance Program Guidance for Pharmaceutical
Manufacturers, forbid the use of “token” consulting arrangements, which might include payments to
investigators to encourage the use of a Pfizer product or to reward an investigator for previous use of a
Pfizer product, rather than to address a genuine scientific issue or obtain meaningful clinical
information. Pfizer policies and procedures, including Direct-to-Consumer (DTC) Clinical Trials
Standard Operating Procedures (SOPs), help ensure that Pfizer-sponsored clinical research and Pfizer
support of IIR studies comply with applicable healthcare laws, regulatory requirements, ethical
standards, and Pfizer-endorsed industry guidelines.
Pfizer-Sponsored Trials
Pfizer-sponsored trials are those studies that are designed, conducted, supervised and funded by
Pfizer and where Pfizer holds regulatory responsibility. Pfizer compensates investigators who
participate in these trials based on the fair market value of their expertise and effort in conducting the
research.
Pfizer-Sponsored Trials: studies that are designed, conducted, supervised and funded by Pfizer and
where Pfizer holds regulatory responsibility.
HCPs often ask colleagues how they can be hired as clinical investigators. Pfizer’s decision whether to
hire an HCP must be made without regard to the HCP’s prescribing history or relationship with Pfizer.
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