DOJ cautions pharmaceutical companies on increased FCPA enforcement
In the months and years ahead the Department of Justice (DOJ) will continue to focus on the pharmaceutical industry in its criminal enforcement of the Foreign Corrupt Practices Act (FCPA), according to the head of the DOJ's Criminal Division. In speeches at the November 12 Annual Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum and again at the November 17 National Forum on the Foreign Corrupt Practices Act, Assistant Attorney General Lanny Breuer noted that, due to the deep involvement of governments in many foreign health care systems, virtually all physicians in many foreign countries may be considered foreign officials under the FCPA. As a result, pharmaceutical companies need to exercise care in their dealings with health care professionals in other countries, due to the substantial risk that certain relationships might be viewed as violations of the FCPA's prohibition on bribery of foreign government officials. The Justice Department believes that any arrangements that, in the United States, would violate the Anti-Kickback Act would, outside the United States, be viewed as violating the FCPA.
Mr. Breuer also emphasized that, in addition to pursuing enforcement actions against corporations, the DOJ increasingly is focusing on investigating and prosecuting senior executives. This point of emphasis was echoed by the head of the DOJ's Civil Division, Assistant Attorney General Tony West, who stated that the DOJ would pursue criminal cases against individuals responsible for illegal conduct whenever possible. Recent enforcement activity corroborates these claims, as individuals were convicted of violating the FCPA's anti-bribery provisions in several recent cases.
As a result of this increased focus on the pharmaceutical industry and enforcement against individuals, pharmaceutical companies operating internationally should re-assess the adequacy of their compliance programs, including conducting appropriate due diligence on their international business partners and other third parties that represent them or act on their behalf.
Popular related articles
-
A female employee of our company filed a Charge with the EEOC that she has been discriminated against because one of our executives is involved in a relationship with a subordinate female employee.
-
HR professionals will tell you that an exit interview is a valuable tool for learning what a company is and is not doing well; what they may not tell you is that exit interviews are also an important tool for managing the risks of the electronic workplace.
-
Most employers assume that any intellectual property ("IP") created by an employee in connection with the employee's job duties will automatically become the exclusive property of the employer.
-
Last week a federal district court in California granted Cisco Systems, Inc. summary judgment on its Computer Fraud and Abuse Act (“CFAA”) claim against an ex-employee who “on multiple occasions and without authorization, . . . used a Cisco employee’s password to gain access to Cisco’s computer systems and download Cisco’s proprietary and copyrighted software.”
-
Open source software has not historically generated much litigation.
-
The Supreme Court has accepted seven labor and employment-related cases to be heard in the Court's next term, which begins in October 2010.
-
This week, President Obama signed into law the "Dodd-Frank Wall Street Reform and Consumer Protection Act" (the "Act").
-
Two recent decisions by United States federal courts serve as useful reminders to companies and their advisors of the rules regarding disclosure of merger negotiations.
-
Spiderman, James Bond, Wonder Woman, Batman – these iconic heroes remain among the best-known fictional characters of our time, and, as characters, are afforded copyright protection, independent of the works in which they appear.
-
In Wisbey v Lincoln, a city employer lawfully (a) required a depressed emergency services dispatcher to submit to a fitness-for-duty exam and (b) fired her when she failed the exam.
-
The Patient Protection and Affordable Care Act of 2010 ("PPACA"), signed into law on March 23, 2010, contains many provisions affecting health care providers.
-
A health care provider that relies on state laws relating to patient preferences to justify making race-based assignments may be creating a hostile work environment and subjecting itself to liability.
-
The funding difficulties for the biotechnology are well known, but financiers have come up with new and innovative ways to respond to these funding challenges - namely the Standby Equity Distribution Agreement ("SEDA").
-
Lifecycle management involving product development and regulatory and/or patent protection for successor drugs is an important aspect of the business plan of most research-based pharmaceutical manufacturers.
-
The federal agencies responsible for Healthcare Reform regulations have recently issued significant guidance, including several model notices, applicable to some of the provisions under the Patient Protection and Accordable Care Act (PPACA) as amended by the Health Care and Education Reconciliation Act of 2010 (the Reconciliation Act; together, the Healthcare Reform Law).
-
On February 17, 2009, President Obama signed the American Recovery and Reinvestment Act of 2009, referred to in the press as the Economic Stimulus Act.
-
Tougher laws are set out in the Bribery Act enacted in April 2010 which will have the effect of imposing extra regulation on the pharmaceutical industry.
-
On 1 July 2010, the General Court issued its long-awaited ruling in the AstraZeneca case.
-
Employers that provide retiree prescription drug coverage should analyze the increased future tax liability and the current accounting charges necessary to retain retiree prescription drug coverage, and evaluate the practical and legal risks of eliminating this benefit.
-
CMS's annual summer tome, the proposed Physician Fee Schedule published this year on July 13, 2010, contains a significant new proposal that if adopted would affect the physicians, hospitals outpatient departments and others that bill for drugs and biologics under Medicare Part B.
-
A decision of the Federal Court provides some useful reminders about misrepresentations by financial brokers and reliance on statements passed on by those brokers.
-
Settlements
(Dorsey & Whitney LLP)
A joint venture between Snamprogetti Netherlands B.V (Snamprogetti), Kellogg Brown & Root Inc. (KBR), Technip S.A (Technip) and the Japanese engineering and construction company (JGC) was formed to bid for and to obtain engineering, procurement and construction (EPC) contracts worth more than $6 billion in Nigeria.
-
On 17 June 2010, Michael Shephard, property developer and Kevin Steele former partner at law firm Mischon de Reya, were charged with offences of conspiracy to defraud relating to the use of falsified bank documents to obtain a bank loan of €22 million.
-
Tougher laws are set out in the Bribery Act enacted in April 2010 which will have the effect of imposing extra regulation on the pharmaceutical industry.
-
The Comprehensive Iran Sanctions, Accountability, and Divestment Act of 2010 (CISADA or "the Bill") was passed by Congress on June 24, 2010, with a vote of 99-0 in the Senate and 408-8 in the House of Representatives.
-
A few months ago, the United States Sentencing Commission unanimously passed amendments to Chapter 8 of the Federal Sentencing Guidelines regarding sentencing of organizations.
-
The Criminal Justice (Money Laundering and Terrorist Financing) Act, 2010 ("the Act") which implements the Third Money Laundering Directive 2005/60/EC ("the Directive") was signed into law on 5th May 2010 and will come into force today, 15th July.
-
AJCongress was founded 91 years ago to fight anti-Semitism and protect civil rights.
-
The Bribery Act 2010 (the Act) was passed on 8 April 2010, but has not yet come into force.
-
It's no secret that the investigation and prosecution of Foreign Corrupt Practices Act (FCPA) violations is drawing increased attention.
-
On July 21, 2010, President Obama signed into law the Dodd-Frank Wall Street Reform and Consumer Protection Act (the "Act").
-
The Comprehensive Iran Sanctions, Accountability, and Divestment Act of 2010 (CISADA or "the Bill") was passed by Congress on June 24, 2010, with a vote of 99-0 in the Senate and 408-8 in the House of Representatives.
-
L'Oreal is the owner of the registered UK, Community and International trademarks for the words TRESOR, MIRACLE, ANAIS-ANAIS and NOA NOA and depictions of the packaging of those brands, all registered in class 3 for perfumes.
-
Damages inquiries in patent cases in Europe are rare.
-
Fraudulent online traps are a phenomenon frequently encountered in Germany.
-
On 1 May 2010, the London Agreement on the Application of Article 65 EPC affecting the requirement to provide translations of European patents (the "London Agreement"), came into force in France.
-
On July 21, President Obama signed the Dodd-Frank Wall Street Reform and Consumer Protection Act (the Act).
-
On July 15, Congress passed the Dodd-Frank Wall Street Reform and Consumer Protection Act ("Act"), which President Obama is scheduled to sign into law on July 21.
-
The FTC announced a consent agreement on 14 May 2010 in which Agilent Technologies, Inc., and Varian, Inc., agreed to certain divestitures in conjunction with Agilent's proposed acquisition of Varian.
-
The Court of Appeals for the Federal Circuit held, in a case of first impression, the determination of whether a protective order should include a patent prosecution bar is a matter governed by Federal Circuit law.
If you are interested in submitting an article to Lexology, please
contact Andrew Teague at ateague@lexology.com.
