Elements of an Effective Compliance Program

In 2003, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) developed the OIG Compliance Program Guidance for Pharmaceutical Manufacturers. According to the OIG, it is essential for pharmaceutical manufacturers to establish and maintain effective compliance programs. The program should foster a culture of compliance that begins at the executive level and filters throughout the organization. The OIG's guidance includes seven fundamental elements to an effective compliance program:

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

Endo's Corporate Compliance and Business Practices department has established a core mission and strategy to create and maintain a culture of compliance through establishment of a robust corporate compliance program that reflects these seven elements.

Corporate Compliance & Business Practices - Mission

Maintain a company-wide culture of ethics and compliance through a program that enables Endo to achieve our strategic vision while maintaining compliance with our policies and procedures as well as with all applicable legal, regulatory, and industry standards.

Corporate Compliance & Business Practices - Strategy

  • Foster a culture guided by "The Endo Way" – honesty, fairness, integrity and personal accountability with a focus on quality and patient safety.
  • Partner with business leadership to drive annual compliance goals.
  • Collaborate with business partners to create policies and procedures that enable the business to operate in a compliant manner.
  • Provide effective training on our Code of Conduct, company policies and procedures and industry standards and regulations.
  • Promote continuous improvement of our compliance program through monitoring and auditing.
  • Provide open lines of communication to allow concerns to be raised in a safe environment and oversee a fair and objective investigation and corrective action process.