In July of 2012, pharmaceutical giant GlaxoSmithKline (GSK) entered into a Corporate Integrity Agreement (CIA) with the U.S. government. The agreement followed a massive settlement in which GSK agreed to pay $3 billion to resolve allegations that it had engaged in illegal and unethical marketing practices.
The CIA was designed to ensure that GSK would take steps to prevent future illegal and unethical conduct. Among other things, the agreement required GSK to establish a Compliance Committee, hire a Compliance Officer, and implement various measures aimed at promoting transparency and accountability.
One of the key provisions of the CIA was a requirement that GSK submit annual reports to the government detailing the company`s compliance efforts. These reports were to include information such as the names and titles of individuals responsible for compliance, the results of audits and risk assessments, and any corrective actions taken in response to identified compliance issues.
The CIA also required GSK to implement various training and educational programs aimed at promoting compliance with legal and ethical standards. For example, GSK was required to provide training on the False Claims Act, anti-kickback laws, and other relevant laws and regulations.
In addition, the CIA required GSK to make certain changes to its sales and marketing practices. For example, the company was required to stop providing financial incentives to sales representatives based on the number of prescriptions written for certain drugs. GSK was also required to implement procedures for reviewing and approving promotional materials before they were distributed to healthcare professionals.
Overall, the CIA represented a significant commitment on the part of GSK to improve its corporate culture and promote ethics and compliance throughout the organization. While the agreement was in effect, GSK was subject to ongoing monitoring and oversight by the government, which helped to ensure that the company remained committed to its compliance obligations.
The GSK CIA serves as a powerful example of the importance of corporate integrity and the need for strong compliance programs in the pharmaceutical industry. By taking proactive steps to address past wrongdoing and promote ethical behavior, GSK has set an example for other companies to follow and helped to ensure that patients receive safe and effective medication from trustworthy sources.