Ethics & Compliance Program Description
Purdue Pharma L.P. and its subsidiaries (Purdue) are committed to establishing and maintaining an effective pharmaceutical 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 (the “HHS-OIG Guidance”). Our Ethics & Compliance Program is a key component of our commitment to the highest standards of pharmaceutical corporate responsibility.
The purpose of our Ethics & Compliance Program is two-fold: to prevent, detect, and remediate violations of law, regulations, or Purdue policies, and to promote a culture of the highest ethics within the organization. It is Purdue’s expectation that employees will comply with our Code of Ethics (Code) and the policies established in support of such Code, as well as our Healthcare Law Compliance Policies. As the HHS-OIG Guidance recognizes, however, the implementation of such a program cannot guarantee that improper employee conduct will be entirely eliminated. In the event that Purdue becomes aware of violations of law or Purdue policy, we will investigate the matter and, where appropriate, take disciplinary action and implement corrective measures to prevent future violations.
The fundamental elements of our Ethics & Compliance Program are listed below. As called for in the HHS-OIG Guidance, we have tailored our Ethics & Compliance Program to fit the unique environment of our organization. Moreover, our Ethics & Compliance Program is dynamic; we regularly review and enhance our Ethics & Compliance Program to meet our evolving compliance needs.
II. Overview of Ethics & Compliance Program
- Leadership and Structure.
- Vice President, Ethics & Compliance. We have selected Margaret K. Feltz as our Vice President, Ethics & Compliance, to serve as the primary contact for compliance activities. We will ensure that Ms. Feltz has the ability to exercise independent judgment and effectuate change within the organization as needed. Ms. Feltz has the responsibility of developing, operating, and monitoring the Ethics & Compliance Program. She reports to Purdue’s General Counsel, is a member of Purdue’s Executive Committee, and has direct access to both Purdue’s Chief Executive Officer and the Board of Directors.
- Compliance Committees. We have established various functional Compliance Committees (e.g., Commercial, Medical Affairs), as well as its Enterprise Compliance and Risk Management Council to advise the Vice President, Ethics & Compliance and assist in the implementation of the Ethics & Compliance Program. These Compliance Committees and other working groups meet regularly to identify and manage areas of risk and areas of critical focus for our organization.
- Written Standards.
- Purdue’s Code of Ethics is our statement of ethical and compliance principles guiding our daily operations. The Code establishes our expectation that management, employees, and agents of Purdue act in accordance with all laws, regulations, and Purdue policies. The Code articulates our fundamental principles and values, providing a framework for action within our organization.
- We have published Healthcare Law Compliance Policies to help address these risks and train our employees to act in accordance with these policies.
- We have established annual spending limits for certain promotional activities directed toward healthcare professionals who prescribe or may influence prescribing in California. At the present time our annual spending limit is $1000.00 per HCP. Examples of items that fall within this spending limit are infrequent, modest, in-service breakfasts and/or lunches for healthcare providers and their staff; infrequent, modest dinners in connection with product specific and non-product educational programs; and items of use to a healthcare professional in his/her practice or to his/her patients. This amount does not include cash payments or honoraria paid to healthcare professionals pursuant to contracts for bona fide consulting or other services. Purdue does not and will not provide any item of value to any healthcare provider with the intent of influencing that healthcare provider’s prescribing habits.
- Education and Training. A critical element of our Ethics & Compliance Program is the education and training of our employees on their legal and ethical obligations under applicable federal healthcare programs. Purdue will effectively communicate our standards and procedures and regularly review and update our training programs.
- Internal Lines of Communication. Purdue actively fosters dialogue among management and employees. Our goal is that all employees should know who to turn to when seeking answers to questions or reporting possible code violations, and should be able to do so without fear of retribution. To that end, we have adopted open-door policies, as well as confidentiality and non-retaliation policies. We have a confidential, toll-free Purdue Ethics & Compliance Hotline (1-877-PURDUE1) through which employees and persons outside of Purdue may report any concerns or suspected violations of law, regulation, or Purdue policy.
- Auditing and Monitoring. Purdue’s Ethics & Compliance Program includes efforts to monitor, audit, and evaluate adherence to Purdue’s compliance policies and procedures. In accordance with the HHS-OIG Guidance, the nature, extent, and frequency of our compliance monitoring and auditing may vary according to new regulatory requirements, changes in business practices, and other considerations.
- Responding to Potential Violations. Purdue’s Ethics & Compliance Program sets forth clear, disciplinary consequences of violating a law or Purdue policy. While each situation will be considered on a case-by-case basis, we will utilize disciplinary action to address inappropriate conduct and deter future violations.
- Corrective Action Procedures. A compliance program increases the likelihood of identifying and preventing unlawful and unethical behavior. However, HHS-OIG recognizes that even an effective compliance program may not prevent all violations. As such, our Ethics & Compliance Program requires Purdue to respond promptly to potential violations of law, regulation, or Purdue policy. Then we can assess whether the violation is due to gaps in our policies, practices, or internal controls, take appropriate disciplinary action, and work to prevent future violations.
Declaration Clause for California, as of July 1, 2019
Purdue Pharma L.P. and its subsidiaries hereby declares that to the best of our knowledge and based on our good faith understanding of the statutory requirements, we have established a Comprehensive Compliance Program (CCP) compliant with the requirements of California Health and Safety Code §§ 119400-119402. The owners, management, and employees of Purdue are committed to conducting our business according to the highest ethical standards. While we cannot completely eliminate the possibility that an individual employee will violate these standards, our program is reasonably designed to detect and prevent violations of state and federal laws as well as our own internal policies and procedures. As of July 1, 2005, the above-referenced compliance program was in place, and we are continually reassessing our Ethics & Compliance Program to improve it.