On January 29, 2013, Deputy Assistant Attorney General Maame Ewusi-Mensah Frimpong spoke at the 2013 CBI Pharmaceutical Compliance Congress and stated that drug safety is a top focus of the Department for 2013. The department is concerned with on-going promotional claims that are not substantiated with clinical data (misbranding) and failure to follow CGMPs. She used examples from Merck, Abbott, and GSK, where these companies promoted their drugs for treatments that had not been approved by FDA. The goal was to increase the bottom line without regard for patient safety. Frimpong also stated that DOJ will be looking at violations of CGMPs where patients are placed at an unacceptably high risk of harm. She suggested focusing on the following 4 points:
- Do you have the right people?
- Do your people have the right incentives to see problems, to report problems, and to fix problems?
- Are your people satisfied and engaged?
- Are your people and policies working in harmony?
- Do you have visibility into what your people are actually doing?
She concluded with “We encourage you to continue to think creatively about how to create a deep and effective culture of compliance within your organizations.”