The shock waves from Pfizer’s 2009 recordbreaking $2.3 billion settlement for off-label marketing continue to reverberate. For example, as part of the recent settlement of a lawsuit filed after paying the huge civil and criminal fine, Pfizer agreed to create a “Regulatory and Compliance Committee” of the Board of Directors, and fund it with a $75 million budget. The Committee will oversee compliance program activities and policies and have the authority to require management to take remedial actions. This new compliance committee goes beyond what OIG required in Pfizer’s corporate integrity agreement (CIA) and is intended to require board engagement in direct oversight of the activities that created problems in the past.

As the number and size of settlements with pharma and medical device companies has increased in recent years, terms in CIAs have evolved to require greater accountability and improvements in compliance program effectiveness. Pfizer’s supplemental agreement to create a “Regulatory and Compliance Committee” is a good example.