White Guide and Orange Guide Formatting Project - Pfizer

Orange Guide – Chapter 5: Interactions with Health Systems and Medical Groups
Assisting a Customer with the Development of a Protocol
Q. One of my customers wants to implement a diabetes screening protocol
within their Health Information Technology (HIT) system. The protocol they
have chosen is not RC-approved, but it was developed by a credible and wellregarded
independent organization and is publicly available. Can I assist with
the implementation (i.e., to advise on appropriate pDPN metrics)?
A. Perhaps, but you must first consult your team attorney before you use or
engage a customer around any resource that hasn’t been expressly RCapproved.
This is a strict requirement, since the protocol may be inconsistent
with Pfizer approved messaging. For example, it may recommend use of a
Pfizer product that is not consistent with the label.
Disease State Discussions with Customers
Q. After preliminary needs assessment meetings the Pfizer team would like to
present to a Health System customer the areas of mutual interests for
potential collaboration. One potential opportunity is in a disease state where
Pfizer has a prominent product. How much can be said about the disease
state and can Pfizer mention its product in the presentation? Will the
presentation need to be approved?
A. The particular disease state and the Pfizer product in that disease state will
dictate how much can be said. In certain cases, where a risk of off-label use
exists, Pfizer’s disease state discussion must be consistent with the label for
the specific Pfizer product. In other cases, the disease state discussion could
be broader, as long as there is no implication that use of the Pfizer product
would result in broader benefits than those mentioned in the product’s label.
Regarding approval, if the discussion around the disease state is more detailed
or the product is mentioned by name, then the presentation will need to be
approved by the product attorney, and may require full brand RC approval.
Note that before presenting to the customer, proposals related to a disease
area should be appropriately vetted with the relevant internal stakeholders in
order to help ensure that all relevant Pfizer stakeholders are aligned with
respect to strategies in disease areas in which we promote. Such stakeholders
may include the respective brand team(s), Channel Strategies and Solutions
Group, Medical and Legal.
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