Notice: This information is provided in accordance with the California Compliance Law, which mandates that pharmaceutical companies operating in California must make their Compliance Program publicly available and provide an annual written declaration affirming their adherence to the requirements of the Compliance Program.
Under the California Compliance Law, pharmaceutical companies are required to establish a comprehensive Compliance Program that aligns with the expectations set forth in the United States Department of Health and Human Services (HHS) Office of Inspector General’s (OIG’s) Compliance Program Guidance for Pharmaceutical Manufacturers (OIG Guidance) and the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Health Care Professionals (PhRMA Code). This includes conforming to any updates or revisions to the PhRMA Code within six months of their publication. ITF Therapeutics LLC (ITF) has implemented a comprehensive Compliance Program in accordance with the California Compliance Law, based on its good faith understanding of the statutory requirements and its interpretation of OIG Guidance and the PhRMA Code.
The California Compliance Law also mandates that companies establish a limit on gifts, promotional materials, or items or activities that may be provided to health care professionals. ITF has established an annual aggregate dollar limit of $2,500 per individual health care professional per calendar year. This limit may be revised by ITF from time to time, in which case the revised limit will be published in this section of the ITF website. This limit does not include the value of drug samples provided to health care professionals intended for free distribution for patients, financial support for continuing medical education forums, financial support for health educational scholarships, and payments made for legitimate professional services (e.g., consulting).
ITF is committed to the highest ethical standards of business conduct and has implemented procedures to identify, detect, and prevent potential violations of its Code of Conduct, internal policies, and applicable laws and regulations. When such violations are identified, ITF takes appropriate and reasonable actions to investigate, discipline, and implement corrective measures, as necessary. Furthermore, ITF regularly reviews and enhances its Compliance Program to ensure its continued effectiveness.
To the best of its knowledge, and based on a good faith understanding of the applicable statutory requirements, ITF is, in all material respects, in compliance with the provisions of California Compliance Law. ITF will update this declaration on an annual basis.
For more information about ITF’s Compliance Program or to obtain a copy of this declaration, please call 1 (866) 483-8479. To report any compliance questions or concerns, please contact our Compliance Hotline (anonymous) at 1 (833) 207-7368 or compliancehotline.itftherapeutics.com.
