The Foreign Corrupt Practices Act Medical Devices

The Foreign Corrupt Practices Act is a United States Federal law enacted in 1974 to create transparency and prevent bribery for U.S.-based corporations conducting business overseas.
News & Analysis as of

GSK Settles SEC FCPA Case for $20 Million

The SEC finished with the last nail in GSK China’s coffin by announcing a $20 FCPA million settlement for GSK’s violations in China. The Justice Department declined to prosecute this case. In 2014, a Chinese court...more

The Oscar Meyer Wiener Theme and Revisiting GSK in China

Last week a true American original died when Richard Trentlage passed away. If you do not know his name you certainly know signature contribution to American culture, the Oscar Meyer Weiner Song. Rather amazingly Trentlage...more

Corporate Investigations and White Collar Defense - August 2016

Spotlight on the False Claims Act - Why it matters: This month, we review a recent Ninth Circuit case that allowed a qui tam relator’s action against various Medicare Advantage organizations to proceed, holding that the...more

Top Ten International Anti-Corruption Developments for June 2016

In order to provide an overview for busy in-house counsel and compliance professionals, we summarize below some of the most important international anti-corruption developments from the past month, with links to primary...more

Battle of the Somme Week – Part I: The Analogic FCPA Enforcement Action

I have not written much in honor of the centennial of the First World War (WWI). However this week I will to remedy this oversight by focusing on the Battle of the Somme, leading up to the first day of the long battle, which...more

AGG Food and Drug Newsletter - June 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Justice Department Announces Largest Settlement Ever For Violations Of The Anti-Kickback Statute By A Medical Device Company

On March 1, 2016, the United States Department of Justice (DOJ) announced that Olympus Corp. of the Americas (OCA), the nation’s largest distributor of endoscopes and related equipment, had agreed to pay $623.2 million to...more

Washington Healthcare Update

This Week: The President took a victory lap in Wisconsin, announcing that 20 million people have gained health insurance through the Affordable Care Act... That figure includes people newly covered through insurance...more

Drug and Medical Device Corruption Risks in China

Medical device and pharmaceutical companies know the risks of conducting business in China. Company after company has had to settle FCPA enforcement actions in China. Many of these enforcement actions include fact patterns...more

Olympus: A Culture of Bribery and Kickbacks

When compliance officers read about a major Justice Department settlement action, we can all hear the collective sigh of relief – “Thank goodness, that did not happen here in my company.”...more

China Regulatory Enforcement Quarterly - Q3 2015

On August 12, a series of explosions in the northern port-city of Tianjin killed over one hundred people and injured hundreds of others. The explosions were allegedly caused by hazardous chemical materials in shipping...more

Four Clear Messages from Bristol Meyers Squibb FCPA Enforcement Action

The SEC’s FCPA enforcement action for $14.6 million against Bristol Meyers Squibb (“BMS”) in China provides a textbook example of how things can go wrong in China. For the compliance practitioner (as well as CEO and...more

Highway 61 Revisited-Tombstone Blues and Corporate Integrity Agreements

I conclude my tribute to my favorite Bob Dylan album, Highway 61 Revisited with a look at the most surreal song on the disc, Tombstone Blues. I want to use it to contrast the most excellent article that appears today as a...more

FAS Russia official recommendations on the commercial policies of manufacturers of pharmaceuticals and medical devices holding a...

On June 30, 2015 on its official site FAS Russia published recommendations for entities holding a dominant position on pharmaceuticals markets and medical devices markets (hereinafter together “pharmaceutical companies”) to...more

SEC Enforcement Director Discusses Issues for Pharmaceutical and Medical Technology Companies

In a wide-ranging speech on Tuesday, Securities and Exchange Commission Director of Enforcement Andrew Ceresney discussed recent SEC actions and current concerns involving the pharmaceutical and medical technology industries....more

The FCPA Year in Review: Twist and Shout (Part I of II)

We all like annual reviews and predictions for the upcoming year – it is a New Year’s rite of passage and one that brings perspective and a sense of order to our otherwise chaotic lives....more

Red Notice Newsletter - November 2013

INTRODUCTION - Welcome to the November 2013 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP. On the anticorruption front, a Swiss tech company’s former exec is charged in the US...more

Ten Required Steps To Ensure Effective Compliance Programs By Pharmaceutical And Medical Device Companies (Part III Of III)

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. ...more

Astros Swept Again – Is A China Sweep Coming Next?

What is a sweep? It is certainly a well-known and relevant term in the sporting world....more

Pharmaceutical And Medical Device Companies: Taking It On The Chin (Part II Of III)

As the Glaxo controversy unravels each day, it is important to remember the enforcement context in which the current prosecution in China is occurring. ...more

Chinese Detain Pharmaceutical Company Managers in Economic Crime Probe

This week, reports have arisen that Chinese authorities in the cities of Shanghai, Beijing, and Changsha detained high-level GlaxoSmithKline (GSK) managers as part of an investigation into potential “economic crimes.” The...more

Clinical Trials And Corruption Risks

Pharmaceutical and medical device companies have enough to worry about when it comes to enforcement risks....more

Pharmaceutical And Medical Device Compliance: Domestic And Foreign Bribery

Pharmaceutical and medical device companies have a raw deal when it comes to domestic and foreign bribery. ...more

Focus on Health Care Firms in FCPA Investigations

I am seeing a lot of interest from health care clients regarding the Foreign Corrupt Practices Act (FCPA). I usually stay away from this topic because so many others cover it in detail. However, I want to point out that in...more

Three Important Lessons from the FCPA Guidance for Pharmaceutical and Medical Device Companies

The US Chamber of Commerce “praised” the FCPA Guidance. The Chamber did not get what it wanted but it had to recognize that the FCPA Guidance was helpful for businesses. The FPCA Guidance provides important information for...more

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