Kite Pharma, Inc. has declared its commitment to support and maintain an effective compliance program in accordance with the “Compliance Program Guidance for Pharmaceutical Manufacturers” published in May 2003 by the Office of Inspector General, US Department of Health and Human Services (The “HHS-OIG Guidance”). As a company, Kite is committed to the highest standards of business conduct, and this Compliance Program is a key part of our efforts to ensure these standards are met.
The goal of the Compliance Program is to help prevent and detect violations of law or company policy with respect to the marketing of our products. The HHS-OIG Guidance recognizes that the implementation of such a program cannot guarantee the complete elimination of improper employee conduct. Kite’s expectation, however, is that employees will comply with our Compliance program and our policies established in support of such program. Kite will investigate any violation of law or company policy and where appropriate take disciplinary action and institute measures to avoid future violations.
The fundamental elements of this Compliance Program are described below. In accordance with the HHS-OIG Guidance, Kite’s Compliance Program is designed specifically for our company. This Compliance Program is subject to fundamental quality standards. On an ongoing basis, we review and enhance our Compliance Program to meet changing legal requirements and our evolving compliance needs.
KITE'S COMPLIANCE PROGRAM Headline Text
- Compliance Officer: The Executive Director of Commercial Legal and Compliance is responsible for developing, operating, and monitoring this Compliance Program. We are committed to ensuring that our Executive Director of Commercial Legal and Compliance has the support and ability to implement change within Kite as necessary.
- Compliance Committees: Kite has established compliance committees to advise the Compliance Officer and assist in the implementation of this Compliance Program.
- Kite’s Compliance Program is our commitment to ethical and compliance principles that direct our ongoing business operations. The Program incorporates our expectation that the company’s management, employees, and agents will act in accordance with the law and applicable company policy. The Program presents our fundamental principles, corporate core values and framework for actions within our organization.
- Our compliance policies address the potential risk areas for pharmaceutical manufacturers as identified by the HHS-OIG Guidance.
- The Kite Compliance Program includes an annual spending limit of $2,000 for certain promotional activities directed toward healthcare professionals. The amount spent on most medical professionals will be less. The limit is set to address the medical professionals who meet most often with the staff of each of our therapeutic areas and attend the most educational dinner programs. This limit does not include payments for legitimate professional services by healthcare professionals as allowed by applicable rules.
- Kite’s Compliance Program includes comprehensive business conduct policies designed to ensure ethical promotional practices that meet and exceed the requirements of law, and comply with the Pharmaceutical Research and Manufacturers of America (“PhRMA”) “Code on Interactions with Health Care Professionals.” Kite regularly evaluates its policies to ensure continued compliance with the PhRMA Code.
Education and Training
- This Compliance Program is maintained by ongoing education and training of our employees on Kite’s Compliance Program and business conduct policies. New employees receive compliance training as part of their initial training, and Kite provides ongoing compliance training and updates for its existing employees. Kite will regularly review and update its training programs and identify additional areas of compliance training as appropriate.
Internal Lines of Communication
- Ensuring dialogue between management and employees is a key component of our Compliance Program. Our goal is that all employees know the company’s compliance reporting policy and are able to report any known or suspected compliance violations without fear of retaliation. Kite has established a committee responsible for receiving and investigating employee complaints. A Kite employee or agent who suspects a policy violation or other wrongdoing is expected to report the incident. Such reports may also be communicated anonymously through an internal website or by calling the 24-hour Ethics hotline at 1-888-631-3121.
Auditing and Monitoring
- Kite’s Compliance Program includes measures to monitor, audit, and evaluate compliance with the company’s compliance policies and procedures. 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.
Kite’s Compliance Program includes clear disciplinary policies that outline the consequences of violating the law or company policy. Each situation must be considered on a case-by-case basis. Appropriate disciplinary action, up to and including termination, will be taken against any employee or agent who violates Kite’s policies or applicable laws and regulations. Disciplinary action will also be taken against any manager who intentionally or negligently permits or condones violations of these policies or applicable laws and regulations.
Corrective Action Procedures
- The goal of the Compliance Program is to help prevent unlawful and unethical behavior and to identify lapses. The HHS-OIG Guidance recognizes that even an effective Compliance Program may not prevent all violations. As such, this Compliance Program requires the company to respond promptly to potential violations of law or company policy, take appropriate disciplinary action, assess the source of the violation, and institute measures to prevent future violations.
Annual Declaration of Compliance Headline Text
As part of Kite Pharma, Inc.’s continuing activities in the area of corporate compliance, we implemented our Kite Healthcare Product Compliance Program effective July 1, 2018. We developed the Compliance Program 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 our company. Based upon our good faith understanding of these statutory requirements, we have initiated this Compliance Program and modified existing procedures accordingly.
No Compliance Program can guarantee that no violations will take place. The goal is to deter violations and identify them as promptly as possible and then facilitate appropriate corrective actions. Since compliance is a dynamic process, we will be evaluating and assessing our Compliance Program on an ongoing basis to adjust to new circumstances and to maintain and improve the strength of the Compliance Program.
This Declaration and the Kite Pharma Healthcare Product Compliance Program may be printed from this website. If you would like to receive printed versions of these documents by mail, you may do so by emailing your request to [email protected] or by calling our toll-free number at 1-855-650-5483.
As of December 31, 2019, to the best of our knowledge, and based on a good faith belief, Kite Pharma, Inc. is in substantial compliance with its Compliance Program and the requirements of sections 119400-119402.