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
more
-- 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
http://www.cuttingedgeinfo.com/pharmacompliancemanagement/PH113_Download.asp#body.
Contact Information: CONTACT INFORMATION:
David Richardson
919-433-0216