White Guide and Orange Guide Formatting Project - Pfizer

Orange Guide – Chapter 2: Detailing to HCPs
Comparative Claim: Comparing any attribute of a Pfizer product to an attribute of another product.
The FDA requires “substantial evidence” to make these claims, which generally means two adequate,
well-controlled studies comparing the two drugs head-to-head using comparable dosage regimens
or a single, large, well-controlled study.
Superlative Claims
Q. Is it ever appropriate to use superlatives like “best” or “safest” in discussing a
Pfizer product?
A. No. It is almost never appropriate to use such unqualified superlatives in
making claims about our products because they are rarely supported by
substantial evidence.
Comparing Product Package Inserts
Q. Can I compare information contained in the package insert of a Pfizer product
with the information in the package insert of a competitor's product?
A. No, you may never make package insert comparisons unless such comparisons
are expressly made in RC-approved materials.
Provide an Accurate and Balanced Presentation
All promotional materials and selling statements must be truthful and not misleading, supported by
substantial scientific evidence, and must appropriately “balance” product safety risks. Promotion is
false and misleading if it does not include relevant risk and safety information or if it is not supported by
appropriate scientific evidence.
The FDA requires that product presentations include a “fair balance” of a product’s benefits and risks.
Thus, relevant safety information must be presented to “balance” any statements on the product’s
efficacy. This is necessary for HCPs to make informed treatment decisions. The more robust the
efficacy statements, the more risk information needs to be provided. This means providing the
relevant warnings, precautions, side effects or other material information that is necessary for an HCP
to make an informed decision. Balanced presentations demonstrate Pfizer’s commitment to improving
patient care and are required by law.
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