Onyx Pharmaceuticals, Inc. (“Onyx”) strives for the highest standards of ethical conduct and is committed to establishing and sustaining an effective Compliance Program in accordance with the “Compliance Program Guidance for Pharmaceutical Manufacturers,” published by the Office of Inspector General, U.S. Department of Health and Human Services (“HHS-OIG Guidance”). The goal of our Compliance Program is to help ensure that Onyx maintains compliance with applicable laws, regulations, and Company policies through appropriate training, and detection of, and response to, potential violations. It is expected that all officers, employees, and agents of Onyx will comply with our Code of Conduct and the policies established in support of the Code.
Described below are the fundamental elements of Onyx’s Compliance Program. Our Compliance Program is designed to fit the unique environment of our company and is regularly reviewed and updated to meet evolving compliance needs.
Leadership and Structure The Chief Compliance Officer has overall responsibility for oversight of Onyx’s Compliance Program, including its development and operation. Onyx is committed to ensuring that the Chief Compliance Officer has the ability to exercise independent judgment and effectuate change within the organization as necessary. In this capacity, the Chief Compliance Officer may report matters directly to the CEO and provide written reports of Compliance Program operation to the Board of Directors.
Written Standards Our Code of Conduct is an articulation of Onyx’s core values and compliance principles. The Code establishes expectations for standards of behavior when conducting business on behalf of the Company and presents a framework for compliance with applicable laws and Company policies. To view Onyx's Code of Conduct, please click here. Onyx’s corporate policies address specific areas of risk potential regarding healthcare fraud and abuse. It is through the realization of corporate policies that Onyx has formally adopted the principles set forth in the “Code on Interactions with Healthcare Professionals” published by the Pharmaceutical Research and Manufacturers of America (“PhRMA Code”).
Onyx does not permit gifts, promotional materials, items, or activities prohibited by the PhRMA Code, HHS-OIG Guidance, or FDA regulations. For items and activities that are not prohibited, Onyx has set a cumulative annual spending limit of $1,200 per healthcare professional in the state of California. These items and activities consist of (1) occasional modest meals given in conjunction with informational educational presentations and discussions that provide educational and scientific value, (2) modest meals and receptions provided to all attendees of Continuing Medical Education (CME) gatherings, and (3) items having a value of $100 or less that are for the benefit of patients or associated with a healthcare professional’s practice.
Education and Training A vital element of Onyx’s Compliance Program is the education and training of our employees on their legal and ethical obligations with respect to applicable healthcare program requirements. Onyx will regularly review and update its training programs, and identify additional areas of training as appropriate.
Internal Lines of Communication Dialogue is encouraged between management and employees. In addition, all employees, when seeking answers to questions or reporting potential instances of fraud and abuse, should know to whom to turn for a meaningful response and be able to do so without fear of retribution. To that end, we have adopted principles regarding confidentiality and policies prohibiting retaliation, as well as established a Compliance Hotline so that issues may be reported anonymously.
Auditing and Monitoring We are continually enhancing our Compliance Program including efforts to improve monitoring, auditing and evaluating adherence to the Company’s compliance activities. In accordance with the HHS-OIG Guidance, the nature of our reviews, as well as the extent and frequency of our compliance monitoring and auditing varies according to a variety of factors, including new regulatory requirements, changes in business practices, and other considerations.
Responding to Potential Violations and Corrective Actions The objective of our Compliance Program is to ensure that the consequences of violating the law or Company policy are clearly understood and that appropriate, consistent disciplinary action is enforced. However, the HHS-OIG recognizes that even an effective Compliance Program may not prevent all violations. As such, our Compliance Program requires the Company to respond promptly to potential violations of law or Company policy; to investigate matters and assess whether there are gaps in policies, practices, or internal controls; and to implement corrective measures to prevent future violations.
Declaration of Compliance July 1, 2012 As a product of our continuing commitment to compliance, Onyx declares that, to the best of its knowledge and based on good faith understanding of the statutory requirements of the California Health and Safety Code sections 119400 and 119402, it has adopted a Compliance Program in accordance with the “Compliance Program Guidance for Pharmaceutical Manufacturers,” as published by the Office of Inspector General, U.S. Department of Health and Human Services. As of the date of this declaration, Onyx believes to be in compliance with this Program in all material aspects.
Contact Information For questions or comments regarding Onyx’s Compliance Program, or to request a printed copy of this Compliance Program summary and our Code of Conduct, you may contact us at 800-503-6571.