FDLI

Food, drug and medical device companies selling their products outside the U.S. face particularly acute risks of running afoul of the Foreign Corrupt Practices Act (FCPA) and similar anti-corruption laws of other countries.  These laws impose civil and potentially criminal liability for improper payments to foreign government officials.   In recent years, the U.S. Securities and Exchange Commission and the U.S. Department of Justice have specifically targeted drug and medical device companies in FCPA enforcement actions.  Multi-million dollar fines have been imposed, particularly for payments, gifts and entertainment provided to employees of state-owned hospitals, as these persons are considered to be “government officials” under the FCPA.  Companies have also found themselves responsible for the actions by sales agents and other intermediaries, even where those actions were not authorized.  These legal risks can be significantly reduced, however, by well-designed compliance policies and procedures.  If an improper payment occurs despite such measures, law enforcement officials are likely to be relatively lenient in any action taken against the company.  By the same token, however, U.S. officials now expect that every company doing business internationally will have taken meaningful steps to prevent improper payments.  If they find a violation by a company that has failed to do so, the consequences will be more severe.

Approximate run time 1.5 hours.