Elements of an Effective Compliance Program

We operate in a highly regulated industry and an increasingly challenging business environment. In 2003, the Office of Inspector General (OIG), Department of Health and Human Services, developed the OIG Compliance Program Guidance for Pharmaceutical Manufacturers. According to the OIG, "it is imperative for pharmaceutical manufacturers to establish and maintain effective compliance programs. These programs should foster a culture of compliance that begins at the executive level and permeates throughout the organization." The OIG's guidance includes seven widely recognized and fundamental elements to an effective compliance program. We have gone a step further by identifying an additional three tenets to complete Amgen's Elements of an Effective Compliance Program. The OIG's seven elements, combined with the additional three tenets identified by Amgen, are the foundation for our Worldwide Compliance & Business Ethics Program.

Core Elements of an Effective Compliance Program

  1. Written policies and procedures
  2. Designated compliance officer and compliance committee
  3. Effective training and education
  4. Effective lines of communication
  5. Internal monitoring and auditing
  6. Enforcement of standards through well-publicized disciplinary guidelines
  7. Prompt response to detected problems through corrective actions

Additional Tenets Identified by Amgen

  1. Compliance metrics reviewed by Compliance Committee to assess program effectiveness
  2. Compliance leadership is part of executive performance reviews
  3. Prompt, balanced and effective decisions regarding compliance activities may require Compliance Committee involvement