Pfizer Corporate Compliance Program
Pfizer's Corporate Compliance Program represents a shared undertaking on the part of colleagues ranging from the highest levels of management to the most junior employees. Our Corporate Compliance Program incorporates the following elements in accordance with the "Compliance Program Guidance for Pharmaceutical Manufacturers" ("OIG Guidance") developed by the United States Department of Health and Human Services, Office of Inspector General ("OIG"):
- Written Policies and Procedures;
- A Compliance Officer and Compliance Committee;
- Effective Training and Education;
- Effective Lines of Communication;
- Internal Monitoring and Auditing;
- Enforcement Through Discipline Pursuant to Published Guidelines; and
- Prompt Response and Corrective Action for Detected Problems.
Written Policies and Procedures
In the United States, some of the policies that provide our colleagues with guidance around their conduct of day-to-day operations include the following:
Revised Global Standards of Business Conduct ("The Blue Book")
The Blue Book is Pfizer's code of business conduct for all colleagues.
Key Principles Guide (May 2004)
The Key Principles Guide applies to all colleagues who support the U.S. Pharmaceuticals business.
The Field Guide ("The Orange Guide") (July 2008) and supplements.
Policies & Procedures: Health care Law Compliance ("The White Guide") (August 2004) and supplements.
Compliance Officer and Compliance Committee
Pfizer's Global Compliance Program operates under the auspices of our Chief Compliance Officer ("CCO"), Douglas M. Lankler. Mr. Lankler is Senior Vice President and Associate General Counsel with Pfizer Inc and reports directly to Amy W. Schulman, the General Counsel of Pfizer Inc. As part of his responsibilities, Mr. Lankler supervises the Corporate Compliance Group. The Corporate Compliance Group consists of attorneys and professionals who are responsible for administering all aspects of the Compliance Program, including compliance training, policy development, and investigations. Mr. Lankler also chairs the Corporate Compliance Committee, which is made up of senior leaders from various divisions within the Company.
Effective Training and Education
Pfizer is committed to providing effective training to employees, managers, officers, and directors regarding the Corporate Compliance Program. Training resources include online access to policies, including the Blue Book, Key Principles Guide, Orange Guide and the White Guide. There is also an online training program that supports compliance education.
Effective Lines of Communication
Open Door Policy
Pfizer adheres to an "Open Door Policy," and encourages colleagues to discuss any issues, concerns, problems and suggestions with their immediate supervisor or other manager without fear of retaliation and with the assurance that the matter will be kept as confidential as possible.
Corporate Compliance Anonymous Hotline
Pfizer maintains toll-free hotlines that are designed to be accessible 24 hours a day, 7 days a week at 866-866-7349 (PFIZ).
Corporate Compliance Inquiry Line
The Corporate Compliance Group in New York Headquarters maintains a local phone number (212-733-3026) for colleagues seeking compliance information or advice.
Corporate Compliance Electronic Mailbox and Fax line
The Corporate Compliance Group has a mailbox at corporate.compliance@pfizer.com, as well as a fax line that can be reached at 917-464-7736.
Communication to Management Regarding Compliance Issues
The Corporate Compliance Group communicates with management about compliance matters. The development and implementation of compliance policy benefit substantially when colleagues at all management levels are engaged.
Communication to the Audit Committee of the Board of Directors and the Full Board of Directors
Communication with the Audit Committee of the Board of Directors and the full Board is part of an effective compliance program. Members of the Board and its Audit Committee are readily accessible to management and the Corporate Compliance Group.
Internal Monitoring and Auditing
Internal monitoring and auditing are vital parts of a Corporate Compliance Program. Monitoring and auditing business processes does more than simply verify their thorough and efficient operation. Effective monitoring and auditing can provide an organization with the capacity to detect and prevent deviations that, in certain circumstances, can potentially engender compliance concerns. The Corporate Internal Audit team maintains responsibility for auditing the policies and procedures of the Corporate Compliance Program.
Enforcement Through Discipline Pursuant to Published Guidelines
Our Compliance Guidance documents (e.g., Blue Book, Key Principles Guide, Orange Guide and White Guide) educate colleagues about our company's commitment to compliance. The Guidance documents put all colleagues, including management, on notice that failure to adhere to our compliance standards may have disciplinary consequences, up to and including termination of employment. If an investigation suggests that discipline, up to and including termination may be warranted, appropriate action is taken.
Prompt Response and Corrective Action for Detected Problems
Our compliance program supports prompt response and corrective action for detected problems as appropriate under the circumstances. It is expected that compliance concerns referred through any of the many communication channels (personal contact, email, anonymous fax, toll-free hotline number, etc.) will be carefully reviewed, thoroughly and thoughtfully investigated, and reasonably timely and appropriately resolved.
Pfizer Policies on Interactions with Health care Professionals In California and Declaration of Compliance
Policies that regulate Pfizer colleagues’ interactions with health care professionals in the United States reflect our commitment to compliance with applicable federal and state laws and regulations. We review and/or revise our policies as we deem appropriate to meet the requirements of a dynamic legal/regulatory and commercial environment. California SB 1765 (California Business & Professions Code §§ 119400, 119402) requires pharmaceutical companies to set an annual aggregate limit on certain promotional expenditures provided to an medical or health care professional as defined under the statute.
The statute excludes from covered promotional expenditures such items as drug samples given to medical or health care professionals intended for free distribution to patients, financial support for continuing medical education forums, financial support for health educational scholarships, and payments made at fair market value for legitimate professional services provided by healthcare professionals.
In light of California SB 1765, Pfizer has modified certain policies and procedures that regulate interactions with covered medical and health care professionals in the State of California. Pfizer has set a specific annual dollar limit on gifts, promotional materials, and items or activities that we may give or otherwise provide to an individual medical or health care professional as defined under the statute.
Subject to the law, Pfizer has determined that the annual aggregate limit on covered promotional expenditures is set at $3,500 per covered medical or health care professional for annual periods commencing on May 1, 2008. This limit may be revised by Pfizer from time to time. The foregoing limit does not represent a usual, customary, average or typical amount for medical or health care professionals.
This annual aggregate limit is based on an estimate of the maximum value of gifts, promotional materials and other items or activities as defined herein that a medical or health care professional may receive in one year. In setting this limit, we have taken into account the size of the Company and the size of its product portfolio. Pfizer is the largest pharmaceutical company in the United States with the largest field force.
The Company markets more than 20 products, many of which are prescribed by the same base of primary care physicians. This often requires multiple interactions with the same physician to provide appropriate information on our products. Our sales force has been advised and will be reminded that this limit applies to covered medical or health care professionals in California. We do not believe it applies to medical or health care professionals practicing in other states. Each category of items or activities that are included in the annual aggregate limit—gifts, promotional materials, and other items or activities—is discussed separately below.
Gifts
The PhRMA Code allows pharmaceutical companies to provide "items primarily for the benefit of patients" and "items of minimal value . . . [that] are primarily associated with a health care professional's practice (such as pens, notepads, and similar 'reminder' items with company or product logos)" if they are not offered or provided in a manner or on conditions that would interfere with the independence of a health care professional's prescribing practices." Our annual aggregate limit on certain promotion-related expenditures excludes the provision of items permissible under the PhRMA Code as being of minimal value (less than a $25 retail value) and primarily associated with a health care professional practice or that primarily benefit patients.
Promotional Materials
Neither California SB 1765, nor the PhRMA Code, nor the OIG Guidance defines "promotional materials." For purposes of this statute, Pfizer interprets that promotional materials are not materials that, under the PhRMA Code, form the basis of our interactions with medical and health care professionals. Accordingly, Pfizer does not include in its definition of "promotional materials," documents and information that inform medical or health care professionals about Pfizer products, provide scientific and educational data, or support medical research and education.
Other Items or Activities
California SB 1765 also subjects to the per-medical or health care professional annual aggregate limit all other "items or activities that the pharmaceutical company may give or otherwise provide to an individual medical or health care professional in accordance with the [OIG Guidance] and with the [PhRMA Code]." We include, among other items in this category, the retail cost of meals provided to covered medical or health care professionals in connection with educational presentations. Historically, Pfizer has not limited attendance at these educational events. The per-medical or health care professional annual aggregate limit on certain promotional expenditures reflects Pfizer's commitment to responsible education and reasonable facilitation of attendance at educational programs in California. To comply with California SB 1765, Pfizer will monitor and limit, if necessary, the number of educational presentations that covered medical or health care professionals may attend in any one year to ensure compliance with the annual aggregate limit.
Declaration of Compliance
On July 1, 2007, Pfizer set an annual aggregate limit on covered promotional expenditures of $2,500 per covered medical or health care professional. In September 2007, Pfizer amended the annual aggregate limit to $3,500 per covered medical or health care professional. Notwithstanding the amended aggregate limit, Pfizer declares, in good faith, that for the reporting period commencing on May 1, 2007 and ending April 30, 2008, it is in compliance with its Comprehensive Compliance Program and the requirements of California SB 1765 and that it has not exceeded its original annual aggregate limit of $2,500 per covered medical or health care professional. Our declaration is based upon an analysis of information available during the twelve (12) month period from May 1, 2007 through April 30, 2008. The next declaration will be based upon information captured beginning May 1, 2008 through April 30, 2009.
Conclusion
We have embedded in the structure of our Corporate Compliance Program and established in our guidelines for interactions with healthcare professionals, the principles articulated in the OIG Guidance and PhRMA Code. As appropriate, and consistent with the law, we will amend and update our policies, and this statement, to assure compliance with the law. A description of Pfizer's Corporate Compliance Program, including the Company's written declaration and certification of compliance with California SB 1765, can be requested via Pfizer's toll-free Compliance Hotline at (866) 866-7349 (PFIZ), by calling the Corporate Compliance Group directly via telephone at (212) 733-3026, or by emailing us at corporate.compliance@pfizer.com.
Note: All policies are subject to regular monitoring and evaluation.
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