White Guide and Orange Guide Formatting Project - Pfizer

P&T Committee Standing Requests for Off-Label Information
Orange Guide – Chapter 7: P&T Committee Interactions
Q. If a P&T Committee has a standing written request for certain information to be
provided during any formulary presentation, and that information includes
information that is off-label or unapproved for promotional use, can a Pfizer
Medical Colleague provide the information even though Pfizer originally asked
for the opportunity to present to the Committee?
A. Yes. Even though Pfizer asked to make the formulary presentation, the P&T
Committee's standing request to be provided with off-label or unapproved
information is considered an unsolicited request for the information. A Pfizer
RMRS is permitted to respond to this standing written request for off-label
information, in accordance with the policies set out in the Green Guide:
Governance for Field-Based Medical Activities.
If the P&T Committee Requested that Pfizer Provide Information
If a P&T Committee makes a documented, unsolicited request for information from Pfizer related to a
formulary decision, you must assess whether the anticipated response will require Pfizer to provide off-
label or other information that is not approved for promotional use.
If the response will not include off-label or unapproved information, any colleague,
including a Sales Colleague, can respond to the request using RC-approved materials.
If the response will likely include off-label or unapproved information, only a Pfizer
Medical Colleague (or Headquarters approved consultant) can deliver the response in
accordance with the guidelines set out for them. Any information provided must be:
o In response to a specific request for that information;
o Truthful and not misleading;
o Based on substantial scientific evidence; and
o Non-promotional in tone.
A MOS Medical Colleague may respond to requests for unapproved but on-label information (e.g.,
where no RC-approved materials exist to use in a response). Because of their background and training,
they may also respond to requests for pharmacoeconomic or outcomes information if they have
materials approved for such responses. A RMRS Medical Colleague may respond to requests for both
unapproved and off-label information. In the absence of a specific request for information about our
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