CA Compliance Statement
This statement is being provided by Syndax Pharmaceuticals (Syndax) pursuant to California Health and Safety Codes §§119400-119402 (Code) which requires pharmaceutical companies to make available their comprehensive compliance program and an annual written declaration of compliance with their compliance program.
Syndax is committed to conducting business in a manner which is built on trust and adherence to the highest ethical standards. Accordingly, we have built a compliance program that is based on the 2003 United States Department of Health and Human Services Office of Inspector General publication “Compliance Program Guidance for Pharmaceutical Manufacturers.” Our compliance program is also informed by the PhrmaCode “Code on Interactions with Health Care Professionals.” Our compliance program is tailored to our size, organizational structure, available resources, and the nature of our business.
Syndax has set an annual dollar limit on gifts, promotional materials, or other items and activities that may be provided to a healthcare professional. The dollar limit is a maximum only. Drug samples intended for free distribution to patients, financial support for continuing medical education forums, financial support for health education scholarships, educational items provided to physicians to give their patients to enhance patients’ understanding or management of a disease state or disorder, and payments for professional services are exempt from this limit pursuant to §119402.
Syndax declares that, to the best of our knowledge, and based on our understanding of the Code, we are in compliance with our compliance program and the Code.
A written declaration of compliance may be obtained by calling 781-419-1400.
Overview of Syndax’s Compliance Program
I. Written Policies and Procedures
Syndax has written policies and procedures that are the backbone of its compliance program. All employees are required to read and understand the policies and procedures. The policies and procedures are periodically reviewed and updated to ensure they are in compliance with federal, state, and local laws, regulations, and guidance. Additionally, they are updated to reflect changes in the industry.
II. Compliance Leadership
Syndax’s compliance program is overseen by a Chief Compliance Officer. The Chief Compliance Officer has direct access to the CEO and Board of Directors. Syndax also has a Compliance Committee that is comprised of members of senior leadership. Together, the Chief Compliance Officer and Compliance Committee oversee Syndax’s compliance program.
III. Training and Education
Syndax conducts training and education on its compliance program for all employees. In addition to reading and acknowledging policies and procedures, employees periodically participate in live and web-based training. The compliance department also provides role-based training on an as-needed basis.
IV. Effective Lines of Communication
All employees are encouraged to raise concerns as they arise either to their manager, HR, compliance, or a member of senior management. Syndax also maintains a third-party maintained hotline which allows employees to report anonymously.
V. Monitoring and Auditing
Syndax’s compliance program includes planned annual monitoring activities as well as additional monitoring at the direction of the Chief Compliance Officer.
VI. Disciplinary Guidelines
Syndax has disciplinary guidelines that have been published for all employees to read and understand. The Company ensures all disciplinary action, as it occurs, is in alignment with these guidelines.
VII. Corrective Action
Syndax’s compliance program ensures that corrective action occurs whenever results of monitoring or other observations dictate that it is needed. Corrective actions are appropriately documented and reviewed by the Chief Compliance Officer, and by other senior executives as necessary.