Compliance Declaration
Abraxis BioScience, LLC ("Abraxis") Policies on Interactions with Healthcare Professionals In California and Declaration of Compliance
Policies that regulate Abraxis interactions with healthcare 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 fix an annual aggregate limit on certain promotional expenditures.
The statute excludes from covered promotional expenditures such items as drug samples given to physicians and 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.
In light of California SB 1765, Abraxis has modified certain policies and procedures that regulate interactions with covered medical and healthcare professionals in the State of California. Abraxis 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.
Subject to the law, Abraxis has determined that the annual aggregate limit on covered promotional expenditures is set at $3,000 per covered medical or health care professional for annual periods commencing on July 1, 2007. This limit may be revised by Abraxis 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 therapeutic area (oncology) and the small size of the Company.
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 healthcare 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 healthcare 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 healthcare 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, Abraxis 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, Abraxis does not include in its definition of "promotional materials," documents and information that inform medical or health care professionals about Abraxis 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, Abraxis has not limited attendance at these educational events. The per-medical or healthcare professional annual aggregate limit on certain promotional expenditures reflects Abraxis's commitment to responsible education and reasonable facilitation of attendance at educational programs in California. To comply with California SB 1765, Abraxis 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
For the annual period commencing on May 1, 2007 and ending April 30, 2008, Abraxis set an annual aggregate limit on covered promotional expenditures of $3,000 per covered medical or health care professional. Abraxis declares, in good faith, that it is in compliance with both its Business Policies Manual/ Compliance Program and the requirements of California SB 1765.
Conclusion
We have embedded in the structure of our Business Policies Manual a Comprehensive Corporate Compliance Program which establishes 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 Business Policies Manual, and this statement, to assure compliance with the law. A description of Abraxis's Corporate Compliance Program, including the Company's written declaration and certification of compliance with California SB 1765, can be requested by contacting:
Richard Maroun- Chief Compliance Officer
Abraxis BioScience
11755 Wilshire Blvd
Suite 2000
Los Angeles, CA 90049
Tel: 310-405-7402 |
