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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Labeling<br />
<strong>Orange</strong> <strong>Guide</strong> - Chapter 1: Overview <strong>and</strong> Key Principles<br />
The FDA strictly regulates the labeling of all prescription drug products that <strong>Pfizer</strong> markets in the<br />
United States.<br />
Labeling: Includes all information on a drug’s package or label, prescribing information contained in<br />
the package insert, <strong>and</strong> any other written, printed or graphic material provided about a drug.<br />
Advertising & Promotion<br />
FDA also strictly regulates the advertising of all prescription drug products that <strong>Pfizer</strong> markets in the<br />
United States.<br />
Advertising: Includes advertisements published in journals, magazines, newspapers <strong>and</strong> other<br />
periodicals, as well as broadcast through media such as radio, television, <strong>and</strong> telephone.<br />
Any materials (whether in print or electronic form) used to promote our products – including all visual<br />
aids, brochures, journal advertising, promotional programs <strong>and</strong> other sales aids – may include only<br />
claims about the product that are consistent with that product’s labeling. In addition, these materials<br />
must contain balanced statements about the product’s benefits <strong>and</strong> safety risks. All promotional<br />
materials, unless exempted “reminders”, must also include the product’s package insert or, for certain<br />
advertisements, a brief summary relating to side effects, contraindications, <strong>and</strong> effectiveness.<br />
With respect to interactions involving the promotion of <strong>Pfizer</strong> products, Sales Colleagues must adhere<br />
to the policies set forth in the <strong>Orange</strong> <strong>Guide</strong> Chapter 2: Detailing to HCPs, <strong>and</strong> all other colleagues must<br />
adhere to the policies set forth in <strong>White</strong> <strong>Guide</strong> Chapter 2: Advertising & Promotional Materials, <strong>White</strong><br />
<strong>Guide</strong> Chapter 3: Promotional Interactions with Healthcare Professionals, <strong>White</strong> <strong>Guide</strong> Chapter 12:<br />
Promotional Interactions with Consumers, <strong>and</strong> <strong>White</strong> <strong>Guide</strong> Chapter 13: Promotional Interactions with<br />
Employer Groups.<br />
Starters (Samples)<br />
The Prescription Drug Marketing Act of 1987 (PDMA) prohibits the sale, purchase or trade of drug<br />
samples (called “starters” at <strong>Pfizer</strong>). It is illegal for any individual (including physicians) to sell (or seek<br />
reimbursement for) a free sample. Individuals who engage in or encourage such conduct are subject to<br />
8<br />
Rev. 09/12<br />
Page 8 of 15
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