In response to the Glaxo controversy and the continuing risks of aggressive FCPA enforcement, drug and device companies need to review and enhance their anti-corruption compliance programs.  No hemming and hawing – this is a must for every company involved in these industries.  To ignore the current situation, is to do more than just put a head in the sand – you might as well bury...

As the Glaxo controversy unravels each day, it is important to remember the enforcement context in which the current prosecution in China is occurring.  The Glaxo case will go down in FCPA enforcement history as the equivalent of the Siemens and Wal-Mart case — it represents a new, and risky trend in anti-corruption enforcement: China is now entering the arena with its enforcement muscle.  For...

Mark Twain, one of my favorite authors, always said it best – “Do the right thing. It will gratify some people and astonish the rest.” For drug and device companies, Mark Twain’s observation is becoming the industry standard.  Since 2009, the drug and device industry has been the proverbial punching bag for FCPA enforcement.  While the overall numbers are less than the major FCPA cases...

Large companies have the resources and the incentive to implement risk management systems.  With the increase in compliance by medium and small-sized companies, chief compliance officers and internal auditors are developing and implementing risk management systems.  I have never been a fan of complicating or confusing compliance and risk management.  After all, risk management naturally belongs in the compliance program functions.  Creating a whole new...

The growing global battle against corruption is finding increasing influence by promoting the link between corruption and human rights.  International organizations are pushing the idea that corruption is antithetical to primary rights, such as political and civil rights, but to so-called “secondary” socio-economic rights which derive from economic opportunity, fair distribution of wealth, and related concepts. The corrupt management of public resources restricts the ability...

Corporate boards are under increasing government and shareholder scrutiny.  The government is climbing the corporate ladder by prosecuting senior executives for civil and criminal violations.  It is only a matter of time until the government will find the right set of facts to try to prosecute a Chairman, or Committee Chair, for a criminal violation. The Dodd-Frank Act increased shareholders’ ability to hold corporate directors...

In the face of unprecedented enforcement risks, Chief Executive Officers are embracing the Chief Compliance Officer. CEOs recognize that they need CCOs to keep the company out of trouble.  General Counsels are still available and important to address legal issues to ensure compliance, but CEOs recognize that CCOs can keep the company out of any trouble.  As a result, more CCOs are reporting directly to...

Pharmaceutical and medical device manufacturers (as well as group purchasing organizations “GPOs”) have a major compliance challenge ahead — the Physician Payment Sunshine Act regulations.  The Sunshine Act requires drug and device manufacturers and GPOs to report to HHS/CMS any “payment or other transfer of value” to physicians and teaching hospitals. The Payment Sunshine Act reporting is scheduled to start on March 31, 2014, for...

We have all watched the familiar scene on Capitol Hill – the latest public scandal like officials from the Internal Revenue Service are dragged up to Capitol Hill to appear before a Committee, raise their right hands, take the oath and then assert their Fifth Amendment right against self-incrimination.  Senators and Congresspersons make comments on the scandal, vilify the witnesses, and promise a thorough Congressional...