backManufacturers and distributors of pharmaceuticals, biologics, medical devices and diagnostics regularly face challenges that may require an internal investigation to determine the root cause of an issue. Such investigations help companies evaluate how best to remediate and guard against future occurrences of a potentially harmful event. These challenges may be industry-specific, such as those related to quality and safety, product labeling and promotion in compliance with the Food, Drug and Cosmetic Act, whistleblower and False Claims Act (FCA) matters, HIPAA protections, supply chain compliance. They may also be 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 is 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.
