The Department of Health & Human Services' Office of Inspector General (HHS OIG) and U.S. Department of Justice (DOJ) have published important guidance and recommendations for pharmaceutical companies to develop and implement effective compliance programs. Both HHS OIG and DOJ have made it absolutely clear that robust, multifaceted compliance programs are a must for pharmaceutical companies. Akin has compiled this guide to help in-house counsel and compliance professionals navigate the evolving compliance guidance provided by both agencies.
In 2023, HHS OIG published the General Compliance Program Guidance (GCPG), providing insights which complement the 2003 Compliance Program Guidance for Manufacturers guidance. The GCPG addresses new issues such as financial arrangements, civil monetary penalties, beneficiary inducements, exclusionary authority, information blocking, Health Insurance Portability and Accountability Act (HIPAA) privacy and security rules, and the role of compliance committees and boards of directors in ensuring compliance. It also emphasizes the inclusion of patient safety and product quality issues in compliance programs. It remains to be seen when HHS OIG might publish an update to the 2003 CPG for Manufacturers as an Industry-Specific Compliance Program Guidance.
Similarly, guidance published by the DOJ's Criminal Division helps inform prosecutors' evaluation of corporate compliance programs. The DOJ's Evaluation of Corporate Compliance Programs guidance provides a roadmap for prosecutors to assess the effectiveness of compliance programs and make informed decisions regarding resolutions, penalties, and obligations, and thus serves as a roadmap for counsel and compliance professionals in designing, maintaining and testing corporate compliance programs. The DOJ guidance has been updated multiple times, with the 2023 version introducing new considerations such as non-disclosure agreements, messaging platforms, autonomy and resources for compliance functions, compensation structures and the use of data to demonstrate program effectiveness.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.