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Lindsey Manufacturing, Senator Stevens and Prosecutorial Misconduct

Lindsey Manufacturing, Senator Stevens and Prosecutorial Misconduct

Prosecutors occupy a unique and powerful position in the criminal justice system. They decide what charges to bring, what plea bargain to offer, what evidence to present at trial, and what sentence to request. In making these decisions, prosecutors must strike the difficult balance between zealously pursuing the conviction of the guilty while remaining objective so as not to overlook evidence of innocence or mitigation....

The Bribery Act and FCPA Summit in Houston — December 7, 2011

The Bribery Act and FCPA Summit in Houston — December 7, 2011

World Compliance – FCPA Houston Event 2011 Join us Join us Wednesday December 7th at the Hilton Houston Post Oak  for a comprehensive look at the lessons learned over the past four years. Learn how DPAs and NPA can help guide your FCPA policy.   Bribery Act and FCPA SummitThe UK Bribery Act has been described as “The FCPA on Steroids.”  For global companies, and for...

Off-Label Marketing Enforcement: The Government's Focus on Medical Device Manufacturers and the Implications for Healthcare Providers

Off-Label Marketing Enforcement: The Government's Focus on Medical Device Manufacturers and the Implications for Healthcare Providers

December 6, 2011 Webinar:  Register Today https://cc.callinfo.com/cc/s/showReg?udc=1siwtt5servd7 Join me and Huron Consulting Group for a webinar discussing current enforcement trends related to off-label marketing of medical devices and the publicity and purchasing oversight implications for healthcare providers. The presentation will focus on: Understanding the off-label marketing prohibition Activities prohibited under off-label marketing prohibition Current enforcement trends and what medical device manufacturers can learn from past investigations into pharmaceutical...

Corruption Risks for Drug and Medical Device Companies

Corruption Risks for Drug and Medical Device Companies

The Justice Department has let everyone know that they are focusing FCPA enforcement on drug and medical device companies.  They have made it clear since at least 2008 that they have a number of companies under investigation.  There has been no let up in this enforcement focus, and DOJ’s efforts in 2012 and 2013 will continue. Pharma and medical device companies have significant corruption risks. ...

Getting Third-Party Agents Under "Control"

Getting Third-Party Agents Under "Control"

You would think that knowing the corruption risks created by use of third-party agents that every company — big and small — would focus on due diligence and anti-corruption compliance for its third-party consultants and agents.   But that is not the case.  Numerous companies have faced the daunting task of applying anti-corruption controls to its third-party agents.  It takes perseverance and commitment.  A dedicated compliance or...

Corporate Governance:  Getting It Right

Corporate Governance: Getting It Right

Without effective corporate governance there cannot be effective compliance.  A good maxim to follow and a basic point which makes sense.  The number of articles, books and thought leaders dedicated to corporate governance is overwhelming.  But somehow we read every week about some new scandal, and how a corporate board was dysfunctional.  Compliance is just one small aspect of corporate governance but a compliance program...

How to Leverage Transparency and Documentation

How to Leverage Transparency and Documentation

“No brilliance is required in law, just common sense and relatively clean fingernails,” John Mortimer (author and creator of Rumpole of the Bailey). Lawyers and compliance professionals like to pat themselves on the back.  Or as I like to say — “don’t break your arm patting yourself on the back.” In the anti-corruption compliance area, we professionals like to advise everyone  to “document, document and...

SEC's Enforcement Division Activity Increases

SEC's Enforcement Division Activity Increases

The SEC is starting to repair its image.  The Madoff scandal dealt a terrible blow to the reputation and morale of the SEC staff. The SEC is quietly increasing its enforcement efforts.  For fiscal 2011, the SEC brought a record number of enforcement cases.  While such figures are impressive, some critics claim that the SEC’s cases do not match the impact of cases brought in the...

DOJ Guidance — What to Expect

DOJ Guidance — What to Expect

The Justice Department bought itself some time to try and help themselves in the FCPA enforcement area.  The Chamber of Commerce and others have criticized DOJ for its failure to provide clear guidance on the meaning of the FCPA and how to comply with the law. The news from the last FCPA industry meeting was supposedly big – Assistant Attorney General Breuer announced that DOJ...

How to Comply In High-Risk Corruption Countries

How to Comply In High-Risk Corruption Countries

Common sense ain’t common.  — Will Rogers Corruption challenges should rarely prevent a company from entering a country’s market.  Assuming that the business case can be made for entering the market, a decision not to enter a market because of corruption reflects a lack of problem solving and compliance creativity.   It is easy to say “no” and list all the reasons not to enter a...