Agency Best Practice in Regulatory Compliance

The pharmaceutical industry imposes higher standards on advertising, PR, and medical education agencies than any other industry, except perhaps the financial services sector. Agencies need to keep up with constantly changing rules for advertising and promoting drugs or devices.

Pharmaceutical companies are hyper-focused on compliance. They cannot afford the high costs of noncompliance, which can include criminal prosecution, corporate integrity agreements, negative media attention, loss of business, and damage to product reputation—not to mention high legal fees and penalties. In the past five years, pharma paid well over $3 billion in government fines. Yet even as regulatory compliance becomes a greater priority for pharmaceutical companies, communications agencies fail to understand the urgency of the issues.

"Agencies that represent drugs or devices must carefully protect their client's reputation, and that means preventing the likelihood of any regulatory violations," says Lynn O'Connor Vos, president and CEO, Grey Healthcare Group. Vos, named 2005 Woman of the Year by the Healthcare Businesswomen's Association (HBA), focused her acceptance speech on strategies to repair people's trust in the industry. "Compliance know-how is clearly an important step for agencies to take as they help restore the tarnished image of the pharmaceutical industry."

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Author(s): 
Wayne L. Pines , Ilyssa Levins .
Journal: 
Pharmaceutical Executive, Feb 2, 2006.