Policies that regulate our colleagues' interactions with healthcare professionals in the United States reflect our commitment to compliance with applicable federal and state laws and regulations. We review and revise our policies as we deem appropriate to meet the requirements of a highly regulated and complex healthcare environment.
California SB 1765 (California Health and Safety Code Sections 119400, 119402 or "Statute"), requires pharmaceutical companies to set a specific annual dollar limit on gifts, promotional materials, and items or activities that pharmaceutical companies may give or otherwise provide to an individual medical or healthcare professional as defined under the Statute. Accordingly, Pfizer has modified certain policies and procedures that regulate interactions with covered medical and healthcare professionals in the State of California.
Additionally, in accordance with California Health and Safety Code Sections 119400, 119402 ("Statute"), our Compliance Program includes policies for compliance with the Pharmaceutical Research and Manufacturers of America (PhRMA) "Code on Interactions with Health Care Professionals."
Annual Aggregate Limit
Subject to this law, Pfizer has determined that the annual aggregate limit on covered promotional expenditures is set at $3,500 per California licensed prescriber or other covered medical or health professional as defined by the Statute 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 healthcare professionals.
The Statute excludes from promotional expenditures such items as drug samples given to medical or healthcare 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.
Pfizer's 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 healthcare professional may receive in 1 year.
In setting this limit, we have taken into account the size of the company and the size of its product portfolio in the United States. Pfizer is one of the largest pharmaceutical companies in the United States with one of the largest field forces.
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 about our products.
Our sales force has been advised and will be reminded that this limit applies to California licensed prescribers and other covered medical or healthcare professionals in California. We do not believe it applies to medical or healthcare professionals practicing in other states and who are not licensed in California.
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.
The Pharmaceutical Research and Manufacturers of America (PhRMA) Code allows pharmaceutical companies to provide "items designed primarily for the education of patients or healthcare professionals if the items are not of substantial value ($100 or less) and do not have value to healthcare professionals outside of his or her professional responsibilities," as long as they are not provided "in exchange for prescribing products or for a commitment to continue prescribing products" or "in a manner or on conditions that would interfere with the independence of a healthcare professional's prescribing practices."
Our annual aggregate limit on certain promotion-related expenditures for purposes of California law excludes from calculation educational items that are permissible under the PhRMA Code.
Neither California Business & Professions Code §§ 119400-119402, nor the PhRMA Code, nor the Office of Inspector General (OIG) Guidance defines "promotional materials." For purposes of this statute, Pfizer does not include in its definition of "promotional materials," documents and information that inform medical or healthcare professionals about Pfizer products, provide scientific and educational data, or support medical research and education.
Other Items or Activities
The statute also subjects to the per-medical or healthcare professional annual aggregate limit all other "items or activities that the pharmaceutical company may give or otherwise provide to an individual medical or healthcare 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 healthcare professionals in connection with educational presentations. Historically, Pfizer has not limited attendance at these educational events.
The per-medical or healthcare 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 the statute, Pfizer will monitor and limit, if necessary, the number of educational presentations that covered medical or healthcare professionals may attend during the reporting period for compliance with the annual aggregate limit.