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OIG chief counsel offers tips to pharmaceutical companies

Pharma Compliance Alert, November 21, 2007

Editor's note: This is the second in a two-part series on OIG Chief Counsel Lewis Morris' remarks at the recent Pharmaceutical Regulatory and Compliance Congress.

OIG chief counsel Lewis Morris provided pharmaceutical insiders with tips to protect themselves and their companies when it comes to off-label marketing of pharmaceutical products during the recent Pharmaceutical Regulatory and Compliance Congress.

According to Morris, pharmaceutical companies should:

• Look at corporate integrity agreements to determine where other companies have had problems
• Identify which products are at the highest risk for off-label promotion
• Look at how sales representatives are communicating with healthcare professionals
• Establish real-world practical training
• Establish systems to track questions received from healthcare providers
• Watch for inconsistencies in the message the company sends to sales representatives
• Review how marketing and sales revenue goals are determined

Morris said the OIG wants to support compliance efforts and will continue to pursue fraud cases.

For more information on training your sales force on the off-label rules and regulations, click here.

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