SOURCE: Cutting Edge Information

June 24, 2008 07:22 ET

OIG Guidelines Significantly Impact Pharmaceutical Compliance Departments

RESEARCH TRIANGLE PARK, NC--(Marketwire - June 24, 2008) - Compliance departments at pharmaceutical companies have had to be even more stringent in their governance of the way they handle their off-label discussions since the introduction of the Office of the Inspector General's (OIG) guidelines, according to a new report by Cutting Edge Information. The study, "Monitoring and Ensuring Pharmaceutical Compliance," reveals that the guidelines, which came out in 2003, have had a significant impact on company practices at 75% of the companies surveyed.

Compliance groups have been chartered to make sense of the guidelines, educate the company on how they impact the business and act as consultants for colleagues who may be challenged by the guidelines. For example, sales and medical affairs teams are affected by the guidelines and look to compliance groups for support. While 62% of companies indicate a significant impact to their compliance efforts, another 13% have indicated an overhaul of company practices. Only 6% of companies report very little impact to operations.

"Compliance groups are now taking proactive roles in their companies," says David Richardson, senior analyst for Cutting Edge Information and lead author of the study. "By taking a dynamic approach to training and monitoring, the compliance team encourages compliant practices throughout the organization."

The 104-page report makes its case with 300+ metrics and numerous insights and industry best practices for managing these three aspects of the regulatory landscape:

--  Structure, Headcounts and Investment -- Provides up-to-date
    structuring strategies, headcounts and investments of top compliance groups
--  Monitoring and Ensuring Compliance -- Details companies' strategies
    regarding monitoring, training, testing, documentation, firewalls, and much
--  Activities and Challenges -- Examines the focus and reach of top
    compliance functions as well as the impact and reactions companies have
    made to recent regulations. Survey respondents also rate the challenges
    facing compliance efforts forward

Key metrics and topic areas in the new pharmaceutical report include:

--  Compliance structures
--  Compliance training and testing methods
--  Firewalls
--  Corporate Integrity Agreements
--  Standard Operating Procedures
--  Risk Assessment
--  Audits
--  Live monitoring
--  Functions trained by compliance departments
--  Benefits of documentation
--  Impact of regulations on companies' practices

To download a free, online summary of this report, visit

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