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Internal Controls Compliance Pharmaceutical Industry

Health Care Compliance Association (HCCA)

[Event] Healthcare Basic Compliance Academy - September 8th - 11th, Scottsdale, AZ

Grounded in the OIG’s General Compliance Program Guidance and DOJ’s Evaluation of Corporate Compliance Programs, our immersive, three-and-a-half-day, classroom-style Healthcare Basic Compliance Academy equips compliance...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Basic Compliance Academy - July 21st - 24th, Nashville, TN

Grounded in the OIG’s General Compliance Program Guidance and DOJ’s Evaluation of Corporate Compliance Programs, our immersive, three-and-a-half-day, classroom-style Healthcare Basic Compliance Academy equips compliance...more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - July 21st - 22nd, Boston, MA

ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more

Thomas Fox - Compliance Evangelist

Novartis FCPA Enforcement Action: Fines, Penalties and the Cost of Recidivism

This week I am reviewing the Foreign Corrupt Practices Act (FCPA) enforcement action involving the Swiss pharmaceutical company Novartis AG, its Greek subsidiary Novartis Hellas S.A.C.I. (Novartis Greece) and Alcon Pte Ltd.,...more

The Volkov Law Group

Novartis and Alcon FCPA Enforcement Action: Lessons Learned (Part III of III)

The Volkov Law Group on

At the outset, Novartis is “lucky” – the settlement is relatively positive, despite its 2016 SEC enforcement action in China.  Given Novartis weak culture of compliance (if anything, a better description may be a culture of...more

Thomas Fox - Compliance Evangelist

Novartis FCPA Enforcement Action: Internal Controls

This week I am reviewing the Foreign Corrupt Practices Act (FCPA) enforcement action involving the Swiss pharmaceutical company Novartis AG, its Greek subsidiary Novartis Hellas S.A.C.I. (Novartis Greece) and Alcon Pte Ltd.,...more

A&O Shearman

SEC Reaches $8.8 Million Settlement With Pharmaceutical Company To Resolve Allegations Of FCPA Violations

A&O Shearman on

On February 28, 2020, the U.S. Securities and Exchange Commission (“SEC”) announced a settled administrative proceeding with an Ohio-based pharmaceutical company, Cardinal Health, Inc. (“Cardinal”) over alleged violations of...more

The Volkov Law Group

Avanir Pharmaceuticals Pays More than $108 Million to Settle Kickback Violations

The Volkov Law Group on

Just to repeat myself – pharmaceutical and medical device firms face extraordinary risks of enforcement under the False Claims Act.  While everyone likes to write and focus on FCPA or anti-corruption risks for global drug and...more

Thomas Fox - Compliance Evangelist

Stryker FCPA Enforcement Action: Compliance Lessons For Distributors and Dealers – Part II

Over this two-part blog post series, I have been considering the Stryker Corporation 2018 Foreign Corrupt Practices Act (FCPA) enforcement action brought by the Securities and Exchange Commission (SEC)....more

Thomas Fox - Compliance Evangelist

Stryker FCPA Enforcement Action: Compliance Lessons For Distributors and Dealers – Part I

Last month, Stryker Corporation joined a rather ignominious list of recidivists under Foreign Corrupt Practices Act (FCPA) enforcement annuls....more

A&O Shearman

Medical Device Manufacturer Enters Into Second FCPA Settlement In Five Years With SEC

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On September 28, 2018, the Securities and Exchange Commission (“SEC”) announced a settlement with a Michigan-based manufacturer and distributor of medical devices, over allegations that the company had violated the books and...more

The Volkov Law Group

Stryker Suffers “Strike Two” and Settles SEC FCPA Case

The Volkov Law Group on

Stryker Corporation has suffered a second FCPA enforcement action, and will now bear the stigma of FCPA “recidivist.” In reaching a settlement with the SEC and agreeing to pay a $7.8 million civil penalty, Stryker will now...more

The Volkov Law Group

Sanofi Coughs Up $25 Million to Settle SEC FCPA Charges

The Volkov Law Group on

Well, add another pharmaceutical company to the FCPA healthcare “sweep.” Frankly, the term “sweep” makes it sound like a coordinated enforcement effort – instead, it is more accurate to think of it as multiple prosecutions...more

The Volkov Law Group

SciClone Pharmaceuticals: A Textbook Case of FCPA Violations for Gifts, Meals, Entertainment and Travel

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The Securities and Exchange Commission continues its steady march as the prominent FCPA enforcement agency against corporations.  The Justice Department has not brought any enforcement actions this year and continues to...more

Thomas Fox - Compliance Evangelist

Bristol-Myers Squibb FCPA Enforcement Action

Yesterday, the Securities and Exchange Commission (SEC) announced a Foreign Corrupt Practices Act (FCPA) enforcement action against Bristol-Myers Squibb Company (BMS) for the actions of the company’s joint venture (JV) in...more

Thomas Fox - Compliance Evangelist

Lessons from GSK in China – Internal Controls, Auditing and Monitoring

One of the questions that GSK will have to face during the next few years of bribery and corruption investigations is how an allegedly massive bribery and corruption scheme occurred in its Chinese operations? The numbers went...more

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