Internal Investigations, Audits and Self Disclosure
We have deep experience handling internal investigations and helping life sciences and healthcare clients avoid, and, if necessary, defend government investigations. We have represented companies on-site during extended hostile inspections of multiple facilities, conducted numerous sensitive internal investigations, managed high-profile congressional inquiries, and represented clients in scientific misconduct and disqualification/exclusion matters. Although our goal is to prevail against the government whenever possible, we have also negotiated landmark consent decrees with FDA and settlements and Corporate Integrity Agreements with the Department of Justice, Department of Health and Human Services (HHS) Office of Inspector General (OIG), and state regulators. We routinely assist clients in developing corrective action plans for various types of regulatory noncompliance, and a major aspect of our practice involves proactive compliance reviews and audits intended to reduce risks and avoid enforcement.
PLI's Medical Devices Law and Regulation Answer Book 2014-15. Ed. By Suzan Onel and Karen Becker