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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On-label Use of Starter<br />
<strong>Orange</strong> <strong>Guide</strong> - Chapter 10: Starters<br />
Q. If a specific dosage of a starter package of a product is not used on-label by a<br />
particular specialty because they never see the appropriate type of patient, but<br />
there is a dosage that can be used on-label by the same specialty, is there any<br />
limitation on what Sales Colleagues can distribute to them?<br />
A. Yes. Sales Colleagues may only distribute starter packages which are<br />
consistent with the on-label use of the product for each particular specialty.<br />
Thus, if a <strong>Pfizer</strong> product has different approved dosages for individual<br />
indications, Sales Colleagues may only distribute those starter dosages that are<br />
indicated for the treatment of conditions that the prescribers they call on are<br />
likely to see among their patient population.<br />
Q. If physicians can prescribe drugs for both on-label <strong>and</strong> off-label uses, can a<br />
Sales Colleague leave starters with a physician who wishes to use them in the<br />
treatment of a patient for an off-label purpose?<br />
A. No. When a Sales Colleague distributes starters, he or she is engaging in<br />
product promotion. Leaving a starter with an HCP implicitly delivers a message<br />
that the product is effective <strong>and</strong> safe for its labeled uses. When an HCP implies<br />
or states that he or she is using a <strong>Pfizer</strong> product for an off-label use, providing<br />
starters to that HCP may be considered off-label promotion <strong>and</strong> may subject<br />
<strong>Pfizer</strong> to prosecution under the False Claims Act. Off-label use can also be<br />
implied if <strong>Pfizer</strong> provides starters to a specialist that does not treat the<br />
condition for which the product is indicated (e.g., Detrol LA to pediatric<br />
urologists, or Viagra to OB/GYNs).<br />
Distribution of Starters to Physicians for Personal Use<br />
Q. If one of a Sales Colleague’s physicians asks her for additional Lyrica starters<br />
because the physician’s spouse suffers from fibromyalgia, can the Colleague<br />
give them to the physician?<br />
A. No. Federal <strong>and</strong> state laws, as well as industry guidelines (the PhRMA Code on<br />
Interactions with Healthcare Professionals <strong>and</strong> the American Medical<br />
Association’s Code of Ethics) prohibit the distribution of starters to HCPs for<br />
their own or their family’s personal use.<br />
186<br />
Rev. 09/12<br />
Page 10 of 17
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