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2.14.2008 - 10:41am ET

CSR News from:	OCEG - Open Compliance & Ethics Group
News Categories:	Business Ethics
	Corporate Governance

OCEG Launches Pharmaceutical Sales and Marketing Supplement for Public Industry Comment

(CSRwire) PHOENIX, AZ. February 14, 2008 – The Open Compliance and Ethics Group (OCEG) today launched the public exposure draft of the Pharmaceutical Sales and Marketing Supplement, an interactive database designed to assist the pharmaceutical industry in understanding legal and regulatory requirements, as well as core business practices, of the Pharmaceutical Sales and Marketing Compliance Program. OCEG will accept public comments on the Supplement through March 31, 2008 at http://www.oceg.org/View/PharmaSM.

"Understanding and implementing the requirements for a company's compliance program can be a daunting task for any executive," says OCEG CEO Scott Mitchell. "The Pharmaceutical Sales and Marketing Supplement public exposure draft gives executives an opportunity to provide commentary on guidelines that are intended to be the gold standard for compliance issues in the pharmaceutical industry. The public exposure and commentary period serves as an opportunity for those most impacted to express their views on the issues around practical business implementation of these guidelines."

Best practices addressed in the Supplement include:

Appropriate interactions with health care professionals on activities associated with independent research, drug samples, and business courtesies

Company support for charitable grants and patient assistance programs

Messaging for promotional materials and scientific information exchange

Government interactions with third party vendors and consumer privacy

OCEG worked with Ernst & Young LLP and the law firm of Hogan & Hartson LLP in writing the Supplement. Members of both firms donated their time to develop the content. They were supported by an Advisory Board of experts who offered comments in the initial scoping of the Supplement structure and reviewed drafts of the guidance.

"This resource will help companies navigate the global compliance waters," says Ted Acosta, Health Sciences Leader in Ernst & Young's, Fraud Investigations & Dispute Services.. "On one hand, users will learn the codes and regulations and the consequences of non-compliance. Yet on the other, it will offer practices and tools from companies with tried and true compliance programs."

"The Supplement is about going beyond the basics of compliance," says Hogan & Hartson Partner Helen Trilling. "Our goal in working with OCEG was to provide in-depth guidance – that surpasses the resources available to date – to assist companies in developing compliance policies geared to meeting applicable legal requirements, government guidance, and industry standards."

"Whether a start-up pharma or biotech company is investigating how to build a compliance infrastructure or a big pharma company is assessing the effectiveness of its compliance program, this will be a global online resource with insights into which programs are practiced around the world," says Dave DeMarco, Ernst & Young Pharmaceutical OCEG Domain Leader. "We anticipate the standards and insights provided will spawn a healthy dialogue between the audit and compliance organizations." The OCEG Pharmaceutical Sales and Marketing Supplement is available to review at http://www.oceg.org/landing/ExposureDrafts.aspx#

BACKGROUND

OCEG is the only nonprofit organization that provides

Common Governance, Risk Management and Compliance (GRC) language and structure − a Framework that can be followed to assess risks then design and evaluate controls for them

Compliance Metrics − Measurements to ensure performance aligns with company objectives

Online Access – a searchable database that provides ready access to key legal requirements (and to the laws and regulations themselves), clearly stated practices to aid with compliance, and tools and resources to make the process easier

A community of practice to share ideas, ask questions, and benchmark against peers OCEG helps organizations drive Principled Performance.(TM) www.oceg.org

For more information please contact:

Carole Switzer, President
OCEG
520 232 0952
520-360-0016
www.oceg.org

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