White Guide and Orange Guide Formatting Project - Pfizer

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Presentations to a Mixed HCP and Consumer Audience Speaker Non-Compliance Meals Orange Guide – Chapter 16: Consumer and Employee Interactions Q. If I organize a speaker program where both HCPs and consumers may be present, does the speaker have to use a Pfizer slide kit approved for a consumer audience? A. Yes. Pfizer must comply with existing FDA requirements and the PhRMA Code Direct-to-Consumer Advertising Principles when interacting with consumers. Therefore, where both consumers and HCPs are expected at the program, the speaker must use an RC-approved consumer slide kit to ensure that information on our products, particularly safety information, is presented in a way that consumers can understand. In addition, any HCPs attending the presentation are subject to Pfizer’s HCP Payment Disclosure policy (See Chapter 18: Meals, Educational Items, and HCP Payment Disclosure). Q. What do I do if a speaker does not conduct a program in compliance with Pfizer’s policies? A. You must promptly and courteously provide clarification to the audience on any inaccurate or inappropriate information. This should be done immediately after the speaker has presented and prior to the Q&A. In addition, if a speaker does not conduct a consumer program in compliance with Pfizer’s policies, you must coach the speaker on the appropriate conduct of a Pfizer consumer program and report the violation electronically upon closing out the program in EZSpeak. Once you have done this, your manager will receive an e-mail notification regarding the violation. Providing a modest meal at an educational speaker program is permissible. However, the cost of food, beverage, tax and tip may not exceed $25/per attendee. No entertainment or recreation may be provided and you should make a good faith effort to avoid utilizing venues which provide entertainment, e.g. hotels with casinos. Where there is a mixed HCP and consumer audience, the meal limit remains $25 per attendee, for both HCP and consumer attendees. Meals may never be provided: (1) to solicit business; or (2) in a manner that might suggest that the recipient was being bribed or improperly influenced. 244 Rev. 09/12 Page 12 of 14
Adverse Events Orange Guide – Chapter 16: Consumer and Employee Interactions Follow Pfizer’s policies on the reporting of adverse events. If a consumer shares information about an adverse event at an educational speaker program, you must report it within one business day by phone (800-438-1985) to the Safety and Risk Management group (SRM). If the consumer will provide it to you, forward his or her name and contact information along with the event to SRM. Refrain from engaging in a detailed discussion with a consumer about an adverse event he or she has experienced. Simply report to SRM a general description of the event and contact information for the consumer if you are able to obtain it. For further information about handling suspected adverse events, visit the PfieldNet Compliance page at http://PfieldNet.pfizer.com/Compliance and select “Handling Reports of Suspected Adverse Events,” listed under Stay In Compliance. Providing Copies of Materials Employees as Consumers Q. Can I hand out copies of the consumer slide deck to consumers in attendance at my consumer program? A. No, you may not hand out copies of the consumer slide deck unless you have received clear guidance from the appropriate RC that this is permissible. However, you may hand out appropriate approved DTC materials. Employers are increasingly making decisions regarding the access their employees have to medicine. As a result, colleagues may have an interest in calling on employers to present information about Pfizer products relevant to the employer in making these decisions. Employers often request that Pfizer interact directly with their employees in the interest of providing health education. These employees are consumers and it is important that Pfizer treat them as such. Accordingly, Pfizer must ensure that it applies the same principles set forth in this Chapter to its interactions with employees. Providing Materials for Non-Pfizer Consumer Events There are also situations in which colleagues may provide RC-approved consumer materials to third parties such as HCPs or patient groups for use in their patient education efforts. Colleagues can provide 245 Rev. 09/12 Page 13 of 14
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