General Counsel Internal Investigations Decision Tree for the Life Sciences Industry

Manufacturers and distributors of health care products, including pharmaceuticals, biologics, medical devices and diagnostics regularly face challenges that may require an internal investigation to determine the root cause of an issue in order to evaluate how best to remediate and guard against future occurrences of a potentially harmful event. These range from industry-specific concerns, such as those related to quality and safety, product labeling and promotion in compliance with the Food, Drug and Cosmetic Act, federal and state healthcare program reimbursement, whistleblower and False Claims Act (FCA) matters, HIPAA protections, supply chain compliance, to more general corporate concerns equally applicable to the entire life sciences industry, such as import/export controls, Foreign Corrupt Practices Act (FCPA) compliance, product liability issues, data breaches, environmental catastrophes and human resource issues. While having a robust compliance program can help avoid many issues, not all issues can be foreseen or avoided. This internal investigations playbook has been designed to facilitate the identification and remediation of issues and is an important complement to a well-designed and functioning compliance program. It also will facilitate the in-house team’s communications with outside counsel, who have a range of experience guiding companies through these precarious situations. In addition, adherence to a well-crafted playbook helps companies meet the expectations of enforcement authorities, such as the Department of Justice (DOJ), the Department of Health and Human Services Office of Inspector General (OIG), the Food and Drug Administration (FDA), the Securities and Exchange Commission (SEC) and state attorneys general (as well as others), which can materially mitigate potential enforcement efforts and sanctions.