Life Science Compliance Update

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May 02, 2016

Do Gold-Standard CIAs Get Blue Ribbon Approval?

Corporate Integrity Agreements are thought to set the standard for compliance programs, but when viewed against the norms set out by a new report from the Ethics and Compliance Initiative's Blue Ribbon Panel, CIAs fall short. This article is the first in a series examining the gap between the compliance programs outlined in CIAs and the Blue Ribbon Panel ethics and compliance (E&C) guidelines, and what companies can do to move their program from a CIA-standards based program to a Blue Ribbon "high-quality" E&C program.

Corporate integrity agreements have long set the standard for comprehensive and effective compliance programs within the life science community. It also is where those seeking to stay ahead of government enforcement look for guidance on how to build their programs. Given that in the event of an investigation, federal officials will look for these elements, they are important considerations for companies looking to maintain an effective compliance program that is eligible for mitigating credit under the Federal Sentencing Guidelines. However, when viewed against the standards set out in the Ethics and Compliance Initiative's (ECI) new report, CIAs fall short of meeting the "exemplary" standard set out by the ECI's Blue Ribbon Panel of practitioners, former enforcement officials, academics, legal experts and public officials. The draft special report issued by ECI's Blue Ribbon Panel in December guides organizations wishing to improve their ethics and compliance ("E&C") programs, identifying what panelists believe to be the characteristics of "exemplary" E&C efforts.8 According to the Blue Ribbon Panel, there are five principles of a high-quality E&C program ("HQP")

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