Quarterly Compliance Reviews under a Federal Corporate Integrity Agreement

Quarterly Compliance Reviews under a Federal Corporate Integrity Agreement

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Case Studies

Advice and Resources

An Extensive Second Request Review Conducted On Time and Over $1M Under Budget

An Extensive Second Request Review Conducted On Time and Over $1M Under Budget

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Non-party FTC CID, 300,000+ document review for large international retailer.

Non-party FTC CID, 300,000+ document review for large international retailer.

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Summary

Client industry:

Pharmaceutical Manufacturing

Business challenge:

Complex substantive framework; reviews every three months

Highlights/outcomes:

Special Counsel has conducted nearly a dozen consecutive reviews; keeping our client compliant with the CIA while meeting timeframe and budgetary targets

Opportunity

Resolving allegations of improper marketing practices for FDA-approved proprietary medications, Special Counsel’s client, a global pharmaceutical manufacturer, entered a 2011 civil settlement with the U.S. Government alongside a Corporate Integrity Agreement (“CIA”). Pursuant to the CIA, the company must retain an independent review provider to conduct quarterly compliance reviews of its internal and external communications. Each review is framed by federal regulations, state laws and corporate policies, while disease state, product information, promotional materials and job descriptions drive the compliance review themes. The company must track and report the findings of each review to the federal government to remain compliant.

The client hired Special Counsel to complete its quarterly compliance reviews beginning in April 2014. Special Counsel has since successfully completed reviews every three months, keeping our client in compliance with the provisions of the CIA.

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