Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is an integrated specialty pharmaceutical company powered by a robust U.S. generics business and a growing branded business. Amneal strives to conduct all aspects of our business in accordance with the highest standards of business ethics and to comply with all applicable laws and regulations that govern our industry.
As part of this effort, Amneal has adopted an enterprise-wide Comprehensive Compliance Program (“CCP”) that is designed to prevent, detect, and resolve potential compliance issues. Our CCP seeks to comply with all applicable federal and state laws, regulations, and industry guidance including the “Compliance Program Guidance for Pharmaceutical Manufacturers” developed by the United States Department of Health and Human Services, Office of the Inspector General and the Pharmaceutical Research and Manufacturers of America’s “Code on Interactions with Healthcare Professionals.” The CCP applies to our officers, directors and employees in their activities on behalf of Amneal, including any of its subsidiaries or divisions.
The Amneal Chief Compliance Officer has primary responsibility for development and implementation of the CCP, including drafting policies and procedures, training, auditing, monitoring, performing investigations, and responding to identified problems. The Chief Compliance Officer provides periodic reports on the operation of the CCP to the Company’s Executive Compliance Committee and the Audit Committee of the Amneal Board of Directors, the body with ultimate authority over the Amneal CCP.
The Amneal Code of Business Conduct is our declaration of ethical and compliance principles that guide our ongoing business operations. It states our expectation that the company’s officers, directors and employees will act in accordance with the law and company policy.
Annual Spending Limit
To ensure that they understand our products, Amneal representatives may meet with healthcare professionals (“HCPs”) to explain their benefits and risks. Some of these informational and educational presentations may take place over the course of a modest meal to minimize the HCP’s time away from his or her patients. In addition to occasional meals, Amneal may provide healthcare-practice related items and other promotional materials in accordance with federal and state laws, regulations, guidance, and our CCP. For purposes of complying with the California Health and Safety Code 119402, Amneal has established a maximum annual aggregate limit of $3500 for gifts (defined as anything of value provided for free, including meals) given to California health care professionals. This limit is a cap, not a goal or average; the amount spent on most health care professionals will be substantially less.
Education and Training
Education is a key element of the Amneal CCP. Amneal is committed to implementing programs that effectively train its employees on company policies and procedures. New employees will receive such instruction as part of their initial training and existing employees are expected to receive compliance training on at least an annual basis. Amneal will review and update its training programs periodically and continue to identify additional areas where training is needed on an ongoing basis.
Amneal expects its employees, officers and directors to promptly report suspected or actual violations of our CCP and laws and regulations governing our business. Amneal encourages reports to be made to a supervisor, manager, or directly to the Compliance Officer. Amneal also maintains a hotline that allows for anonymous reporting of any compliance concerns and a process for investigating and documenting those concerns. Reports can be made to the Amneal Ethics & Compliance Hotline online at amneal.ethicspoint.com, or toll-free by telephone at 1-877-412-8817.
Auditing and Monitoring
As part of the CCP, Amneal conducts auditing and monitoring activities designed to assess compliance with the CCP policies, procedures and processes, identify potential training needs, and identify policy, procedure or process needs.
Responding to Potential Violations
Amneal is committed to compliance and strives to maintain an active and effective CCP. Disciplinary actions for compliance program violations are addressed in the Amneal Code of Business Conduct. Amneal has a progressive disciplinary process up to and including termination of employment depending upon the severity of the violation. Disciplinary actions will be timely implemented to ensure that the incident is resolved and to prevent any potential reoccurrence.
Amneal Pharmaceuticals, Inc. Compliance Program Declaration
Amneal declares that, as part of our continued focus on compliance, we have developed a Comprehensive Compliance Program that, to the best of our knowledge and as of the date of this declaration, is compliant with the requirements of California Health & Safety Code §§ 119400-119402, and Amneal is in all material respects compliant with its CCP.
Copies of this declaration may be obtained by contacting AmnealCompliance@amneal.com.