Device and pharmaceutical compliance officers have, over the years, worried that their foreign employees might unwittingly trigger a multi-million dollar fine over a cup of coffee or an innocent cab ride.
Last August, Pfizer agreed to pay $60 million for illegal payments made by its subsidiaries to foreign officials to obtain regulatory approvals, sales and prescriptions for its products.
For the past two years, industry groups have called for a new detailed written Foreign Corrupt Practices Act (FCPA) guidance. Heeding their calls, in November 2012 the DOJ and SEC released a 130-page resource guide.
The guidance breaks new ground and clarifies lingering concerns regarding:
Discover how to overcome this latest compliance challenge while doing business internationally. FDAnews presents a 90-minute CD/Transcript where you can gain piece of mind in understanding the most comprehensive FCPA guidance.
In light of the new guidance from DOJ and the SEC, companies should consider re-evaluating their current FCPA compliance programs.
Now, more than ever, you need expert opinion regarding how DOJ and the SEC have exercised their prosecutorial discretion, how they might treat numerous hypothetical situations, and how they interpret key sections of the FCPA.
Noted attorney Keith Korenchuk of Arnold & Porter LLP shares with you his proactive, proven plan for FCPA compliance. You will understand:
While the guide may clarify many issues regarding how DOJ and the SEC exercise their prosecutorial discretion, it does not make FCPA compliance any easier.Compliance and due diligence are becoming increasingly complex as companies are facing increasingly divergent regulatory environments in the different jurisdictions where they do business. Get your proactive FCPA plan in place before it’s too late.
This is a must for professionals in drug, biotech, device, biologics and diagnostics companies, including:
Keith Korenchuk, partner with Arnold & Porter, LLP, counsels and advises global companies on regulatory and compliance matters worldwide, with a focus on compliance program effectiveness, compliance program implementation, operations and evaluation, and related regulatory counseling and advice. He works in a wide variety of industries and sectors, including consumer products, electronics, energy, financial services, life sciences, medical devices, pharmaceuticals, and technology.
Mr. Korenchuk's prior experience includes serving as the CEO of a company that focused on pharmaceutical and healthcare sector compliance, as well as the CEO of a research and development company that focused on homeland security technologies. Since 2001, Mr. Korenchuk has been included in The Best Lawyers in America® and holds an M.P.H. from Harvard and a J.D. from the University of Virginia.
Samuel Witten, counsel with Arnold & Porter, LLP has an extensive background in international law, the development and implementation of corporate compliance programs, international dispute settlement, and international law enforcement cooperation. Before joining Arnold & Porter, he served in the U.S. Department of State for 22 years, including 19 years in the Office of the Legal Adviser where he was Deputy Legal Adviser from 2001-2007. He also held three senior State Department foreign policy positions, including Acting Assistant Secretary of State, where he managed the State Department's international refugee assistance programs and the resettlement of refugees into the United States.
Mr. Witten helps companies develop and implement compliance programs and corrective actions related to the Foreign Corruption Practices Act, the UK Bribery Act, and other legislation. He advises companies on issues of corporate social responsibility. He also represents domestic and international clients in litigation and arbitrations and in domestic enforcement and regulatory matters, and has represented foreign governments in dispute resolution and public international law matters. His practice also includes economic sanctions and issues relating to international law enforcement cooperation.
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