Category: OIG Compliance Program Guidance for Pharmaceutical Manufacturers

Developing the Compliance Program Guidance for Pharmaceutical Manufacturers

On June 11, 2001, the OIG published a solicitation notice seeking information and recommendations for developing compliance program guidance for the pharmaceutical industry (66 FR...

Background

SUPPLEMENTARY INFORMATION: Compliance program guidance is a major initiative of the OIG in its effort to engage the health care community in preventing and reducing...

Endnotes

1. The term ‘‘Federal health care programs,’’ as defined in 42 U.S.C. 1320a– 7b(f), includes any plan or program that provides health benefits, whether directly,...

III. Conclusion

In today’s environment of increased scrutiny of corporate conduct and increasingly large expenditures for prescription drugs, it is imperative for pharmaceutical manufacturers to establish and...

II. Compliance Program Elements Reporting

Where the compliance officer, compliance committee, or a member of senior management discovers credible evidence of misconduct from any source and, after a reasonable inquiry,...

II. Compliance Program Elements H. Responding to Detected Problems and Developing Corrective Action Initiatives

Violation of a pharmaceutical manufacturer’s compliance program, failure to comply with applicable federal or state law, and other types of misconduct threaten the company’s status...

II. Compliance Program Elements G. Enforcing Standards Through Well-Publicized Disciplinary Guidelines

An effective compliance program should include clear and specific disciplinary policies that set out the consequences of violating the law or the pharmaceutical manufacturer’s code...

II. Compliance Program Elements F. Auditing and Monitoring

An effective compliance program should incorporate thorough monitoring of its implementation and an ongoing evaluation process. The compliance officer should document this ongoing monitoring, including...

II. Compliance Program Elements E. Developing Effective Lines of Communication

1. Access to Supervisors and/or the Compliance Officer In order for a compliance program to work, employees must be able to ask questions and report...

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