White Guide and Orange Guide Formatting Project - Pfizer
White Guide and Orange Guide Formatting Project - Pfizer
White Guide and Orange Guide Formatting Project - Pfizer
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Hospital Protocols<br />
Comparative Claims<br />
<strong>Orange</strong> <strong>Guide</strong> – Chapter 2: Detailing to HCPs<br />
Q. May I detail an HCP who is involved in the development of a hospital clinical<br />
protocol or who is in a position to influence which products are included in a<br />
hospital clinical protocol?<br />
A. Yes. You may detail any such HCP if your detailing is otherwise done in<br />
accordance with all applicable <strong>Orange</strong> <strong>Guide</strong> principles, including the four Core<br />
Compliance Principles discussed in this Chapter.<br />
Q. May I detail an HCP in order to ask the HCP to consider inclusion of a <strong>Pfizer</strong><br />
product in a hospital’s clinical protocol?<br />
A. Yes. <strong>Pfizer</strong> colleagues may encourage an HCP to consider including a <strong>Pfizer</strong><br />
product in a hospital protocol or st<strong>and</strong>ing order provided that such promotion is<br />
strictly limited to approved, on-label messaging of the <strong>Pfizer</strong> product <strong>and</strong> all<br />
<strong>Orange</strong> <strong>Guide</strong> principles are followed.<br />
Q. May I participate in the development of a hospital clinical protocol?<br />
A. No. <strong>Pfizer</strong> Sales Colleagues are not permitted to assist hospitals with drafting<br />
or otherwise developing hospital clinical protocols or treatment st<strong>and</strong>ing<br />
orders.<br />
Q. May I use a hospital protocol in detailing sessions?<br />
A. Only if the Review Committee has approved the use of such hospital protocol.<br />
You may not distribute the protocol <strong>and</strong> it may not be used outside of the<br />
originating institution.<br />
You can only make comparative claims when there are <strong>Pfizer</strong> RC-approved promotional materials<br />
(including iCUE slides <strong>and</strong> any applicable product Implementation <strong>Guide</strong>s) that expressly make<br />
such claims. The FDA considers promotional materials or claims to be false <strong>and</strong> misleading if they<br />
state or suggest that a drug's safety or efficacy is comparable or superior to that of another drug's<br />
without “substantial evidence” to support such statements or suggestions. It is not appropriate to<br />
make comparative claims based on the data in products' respective package inserts. Similarly, because<br />
of the differences in clinical trial designs, inclusion criteria, <strong>and</strong> other factors, it is not permissible to<br />
compare results from two non-comparative trials.<br />
29<br />
Rev. 09/12<br />
Page 14 of 29
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