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