White Guide and Orange Guide Formatting Project - Pfizer

Orange Guide – Chapter 2: Detailing to HCPs
Detailing and Sales Materials: On-Label vs. Off-Label Claims
On-Label Claims (Appropriate) Off-Label Claims (Inappropriate)
Statements about a product's efficacy within a
population of patients specifically identified in
the package insert
Statements about the safety of a product that
are consistent with the information in the
package insert
Statements that accurately reflect an approved
indication
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Statements about a product's efficacy within a
population of patients who are not included in
the product labeling
e.g.: Pristiq can be used in pediatric patients
Statements about the safety of a product that
are overly broad or minimize risk
e.g.: Toviaz is well tolerated and patients do not
really experience side effects
Statements that inappropriately broaden an
indication
e.g.: Lyrica is effective therapy across the full
spectrum of painful neuropathic conditions
Rev. 09/12
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