Statement regarding compliance with California Health & Safety Code § 119402
California Health & Safety Code, Sections 119400 – 119402, (“California Code”) requires pharmaceutical companies to adopt a compliance program in accordance with the April 2003 publication “Compliance Program Guidance for Pharmaceutical Manufacturers” (“OIG Compliance Guidance”) developed by the United States Department of Health and Human Services Office of Inspector General (“OIG”) and policies for compliance with the Pharmaceutical Research and Manufacturers of America (“PhRMA”) “Code on Interactions with Health Care Professionals” (“PhRMA Code”) within six months of any update or revision of the PhRMA Code.
Tris Pharma, Inc. (“Tris” or “Company”) has established a Compliance Program in accordance with the OIG Compliance Guidance and has policies in place to foster compliance with the PhRMA Code. For purposes of compliance with the requirements of the California Code and as part of the Compliance Program, Tris has established a specific annual aggregate dollar limit of $2,000 on gifts, promotional materials, or items or activities that Tris may give or otherwise provide to an individual medical or healthcare professional in California on an annual basis from January 1 to December 31. Such items or activities primarily include: medical educational items such as textbooks or clinical reprints, intended to enhance patient care; modest meals associated with a substantive discussion of a Company product or a disease state; and other items or activities permitted under the PhRMA Code, the AdvaMed Code of Ethics for Interactions with Healthcare Professionals and/or the OIG Compliance Guidance. These items and activities are primarily directed to the dissemination or communication of medical and scientific information as a resource for healthcare professionals to assist in making clinical or other medical judgments. This limit may be revised from time to time, in which case the revised limit will be published in this section of the Company website. This limit represents a spending cap, not a goal or average; in many cases, the amount spent per prescriber is substantially less than the cap amount.
In accordance with the California Code, the annual limits do not include the following:
- drug samples given to physicians and healthcare professionals
- financial support for continuing medical education forums
- financial support for health educational scholarships
- payments made at fair market value for legitimate professional services, and any meals or expenses associated with the provision of those services
Annual Declaration of Compliance
Tris’ Compliance Program was developed with consideration given both to the goals of sections 119400-119402 of the California Health and Safety Code and to the operations, size, and organization of the Company. Based upon our good faith understanding of these statutory requirements, we believe we are in compliance in all material respects with our Compliance Program and the requirements of the California Health and Safety Code.
Tris Compliance Integrity Hotline
Tris’ Compliance Integrity Hotline allows colleagues or partners to report a concern anonymously. Where available, the Compliance Hotline can be reached by phone or inquiries can be made via email. The Compliance Hotline is available seven days a week, 24 hours a day. The Compliance Hotline is operated by specially trained third-party representatives in the United States.
To Make a Report:
- By phone within United States, US Territories and Canada call 1-732-647-3984.
- Alternatively, matters may be reported by contacting Tris Customer Concerns and Product Issues at (732) 940-0358; Fax: (732) 940-0374 or ProductComplaints@trispharma.com
The reporter will be asked for details about the issue or question and given a means for follow up. Though not required, individuals are encouraged to leave a name and number in case additional information is needed.