Santen Holdings U.S. Inc. and Affiliates Compliance Program
Section 119402 of the California Health & Safety Code requires a pharmaceutical company to adopt a Comprehensive Compliance Program that is in accordance with the U.S. Department of Health and Human Services, Office of the Inspector General’s ("OIG") "Compliance Program Guidance for Pharmaceutical Manufacturers" ("OIG Compliance Guidance"), and include policies for complying with the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals ("PhRMA Code"). Further, the law requires that the Comprehensive Compliance Program include an annual limit for certain items and activities given to healthcare professionals licensed in California.
Santen Holdings U.S. Inc. and its affiliates declare that as of January 1, 2009, it has adopted a Comprehensive Compliance Program designed to comply with all applicable federal and state laws and regulations related to the marketing and promotion of our products. As of the date of this declaration, based on our good faith knowledge of the statutory requirements and to the best of our knowledge, Santen is, in all material respects, in compliance with both California Health & Safety Code, §§ 119400-402 and our Comprehensive Compliance Program. Any changes Santen makes to its Comprehensive Compliance Program in the future shall remain compliant with state and federal laws and regulations, the OIG Compliance Guidance, the PhRMA Code, and industry best practices. Santen also has established an annual limit of $2500 per individual healthcare professional, as permitted by the aforementioned PhRMA Code.
Copies of this Declaration and our Comprehensive Compliance Policy may be obtained by contacting Santen’s Chief Compliance Officer, Connie Stueland, at the following toll-free phone number: 1-800-611-2011.
