Global Pharmaceutical Manufacturer’s Reactive Response to a Corporate Integrity Agreement

Background and Challenge

While a global pharmaceutical company was under a Corporate Integrity Agreement (CIA), an associated brand was issued Risk Evaluation Mitigation Strategies (REMS) requirements. The compliance team had recently gone through substantial personnel and leadership changes. They needed a better way to coordinate, track, and document their oversight activities to demonstrate CIA and REMS adherence. They also needed an effective method to monitor the activities of their Medical Liaisons and Promotional Speaker programs.

The company turned to WLH for compliance support and the I GLASS™ Field Based Monitoring system. The goal was to quickly design a process that incorporated the best practices of pharmaceutical compliance and fully supported the CIA and REMS requirements for the brand. During the initial engagement, WLH also recognized the need for the compliance team to better engage with the sales and brand marketing teams. As a result, WLH supported the organizational alignment of these functions.

Approach and Deliverables

WLH conducted a rigorous evaluation of the promotional materials and approved scientific literature in place to support the brand. WLH then completed an analysis of the company’s compliance procedures related to training, product promotion, and meeting internal and external reporting requirements. The company requested WLH to deliver:

• Improvements to the structure, alignment, and responsibilities of the compliance department
• Documented working agreements to foster greater collaboration between Compliance, Sales, and Marketing
• Updated SOPs to communicate company compliance expectations for interactions with prescribers
• Behavior-based training to advance the capabilities of the compliance monitors
• Product-specific assessment audits to be used during field based monitoring
• I GLASS™ field based monitoring process
• Automated compliance data collection process to facilitate delivery of REMS data to the US Government
• Customized reports to identify trends and validate compliance requirements

Results

The organization further expanded the scale of their Compliance team and implemented a new, web-based approach to field based monitoring. WLH was then asked to expand the I GLASS™ System to support the compliance needs of the company’s other brands. Manual data collection and storage processes were eliminated.