NOTICE: this information is provided pursuant to the requirements of Cal. Health & Safety Code § 119402 (S.B. 1765), which requires certain pharmaceutical and medical device companies doing business in California to make available their program for compliance with applicable federal and state laws and industry standards regulating the marketing and promotion of their products.
As required by California Health and Safety Code § 119402 (S.B. 1765), Foundation Medicine, Inc. (“Foundation Medicine”) has established a Compliance Program to ensure adherence with all applicable laws and guidance, including those that govern the marketing and promotion of certain medical devices.
Leadership and Structure
Our Compliance Program has been developed by Foundation Medicine’s Compliance leadership and is managed by its Chief Compliance Officer. The Chief Compliance Officer reports directly to the Chief Executive Officer and is empowered with the appropriate authority to effectuate change within the organization and exercise independent judgment.
Written Policies and Procedures
Foundation Medicine has written policies to assure substantial compliance with the applicable laws and regulations and standards governing the marketing and promotion of our products. Among these standards are recognized industry codes of conduct including the Code of Ethics on Interactions with Health Care Professionals (AdvaMed Code), published by the Advanced Medical Technology Association.
Foundation Medicine has established an annual dollar limit for spending on meals and promotional materials of $2000 per California healthcare professional. This limit represents a spending cap and not an average or target, and in most instances the amount spent per healthcare professional will be substantially less than this annual limit.
Foundation Medicine has annual Compliance training that includes testing and annual certification of appropriate employees. The training covers the applicable guidelines governing our Compliance Program.
Foundation Medicine encourages employees report potential compliance incidents and seek guidance in resolving ethics and compliance questions.
Auditing and Monitoring
Foundation Medicine periodically audits its compliance with its policies and procedures. These audits are intended to identify potential or existing problem areas and to take corrective measures as well as to explore opportunities to enhance its processes and practices.
Investigating and Responding to Potential Violations
Foundation Medicine’s Compliance Department monitors company functions and activities for potential violations of law, regulation, the Code of Conduct, and company policies and procedures. Potential violations are promptly and thoroughly investigated as appropriate.
Foundation Medicine requires a prompt and diligent response to potential violations of the company’s Compliance Program. Actions in response to detected problems may include improving policies, procedures, training, communication and monitoring, or may require disciplinary action to prevent future violations.
Foundation Medicine has developed a Comprehensive Compliance Program that is designed to comply with applicable federal and state laws and industry standards relating to the marketing and promotion of our products. To our knowledge as of the date of this declaration, Foundation Medicine is in compliance with our Comprehensive Compliance Program, as described here, and with California Health & Safety Code sections 119400-119402.
A copy of this California Comprehensive Compliance Program and Declaration may be obtained by calling (888) 988-3639.
Posted Date: January 2020
Need More Details?
Our client services team is here to help, Monday through Friday 8AM – 8PM EST.