The U.S. Department of Justice (DOJ) and Securities and Exchange Commission (SEC) have made enforcement of the Foreign Corrupt Practices Act (FCPA) a top priority, especially as it relates to pharmaceutical and medical device manufacturers. No pharmaceutical and device manufacturer can expect to evade a government investigation indefinitely. Even smaller companies need to be able to demonstrate that they exercise due diligence, either in the event of an investigation or if they ever seek to partner or merge with a larger company.

This audio conference presentation provides guidance for companies with international operations on how best to develop and implement a set of internal controls to reduce enforcement risk under the FCPA and other international anti-corruption laws.

This audio conference covers:

• How an FCPA investigation comes about
• How to conduct a self-assessment of FCPA risk
• Balancing FCPA and anti-corruption obligations with international privacy regulations
• Essential elements of an FCPA compliance policy
• What to do about hospitality and entertainment of foreign officials
• How to deal with foreign sales agents or distributors
• Common FCPA questions and answers

About the speaker:

Jesse A. Witten is a partner in the Washington office of Drinker Biddle & Reath. He previously served as Deputy Associate Attorney General of the United States, where his duties including co-chairing the DOJ’s health care fraud enforcement task force.

In private practice, Jesse counsels medical device companies on marketing and promotion issues, including off-label marketing and compliance with the Anti-Kickback Statute and the Foreign Corrupt Practices Act. He has also defended medical device and pharmaceutical manufacturers, and health care providers, in litigation and investigations under the False Claims Act predicated on a wide range of alleged violations, including fraud on the FDA, promotion of non-FDA-approved devices, Anti-Kickback violations, and Medicaid and Medicare Part B price reporting.

Who should attend?

• General Counsel
• Assistant General Counsel
• Associate General Counsel
• Vice Presidents of Marketing
• Vice Presidents of Sales
• Internal Audit Directors
• Compliance Officers