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Securities and Exchange Commission (SEC) Compliance Pharmaceutical Industry

Morrison & Foerster LLP

Top 10 International Anti-Corruption Developments for June 2025

Designed for busy in-house counsel, compliance professionals, and anti-corruption lawyers, this newsletter summarizes some of the most important international anti-corruption law and enforcement developments from the past...more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - May 9th - 10th, New York, NY

Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...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

American Conference Institute (ACI)

[Virtual Event] FCPA & Anti-Corruption for the Life Sciences Industry - April 14th, 10:00 am - 6:00 pm EDT

Virtual Forum on the FCPA & Anti-Corruption for the Life Sciences Industry will take place on April 14, 2021 (Eastern Daylight Time). This is the only practical, comprehensive anti-corruption event that is truly tailored to...more

Morrison & Foerster LLP

Top 10 International Anti-Corruption Developments For July 2020

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

The Volkov Law Group

Episode 149 -- A Deep Dive into Alexion's SEC Settlement for FCPA Violations

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Notwithstanding the pandemic and remote working arrangements, the Securities and Exchange Commission is continuing to bring FCPA enforcement actions. In its latest action, the SEC settled with Alexion Pharmaceuticals for $21...more

The Volkov Law Group

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

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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

The Volkov Law Group

Novartis and Alcon Settle FCPA Violations for $345 Million (Part I of III)

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Even during this difficult time of the pandemic, economic uncertainty and social unrest, the Justice Department and the SEC have concluded a major FCPA enforcement action....more

A&O Shearman

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

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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

Foley Hoag LLP - White Collar Law &...

White Collar Year in Preview: Healthcare Fraud Trends in 2020

Editors’ Note: This is the second in our start-of-year series examining important trends in white collar law and investigations in the coming year. Our previous entry discussed SEC enforcement in 2020. Up next: a look at...more

The Volkov Law Group

2019 FCPA Enforcement Highlights (Part II of III)

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In a record year, there are bound to be numerous interesting enforcement actions and principles.  I picked out a few to highlight....more

The Volkov Law Group

FCPA 2019: A Record Year in Enforcement and Compliance (Part I of III)

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Happy New Year!! In the FCPA arena, 2019 was a record year – in enforcement and compliance. Many continuing trends are becoming more than trends – meaning they are turning into established practices....more

Skadden, Arps, Slate, Meagher & Flom LLP

Cross-Border Investigations Update - September 2019

This issue of Skadden’s semiannual Cross-Border Investigations Update takes a close look at recent cases, regulatory activity and other key developments, including a review of the first year of GDPR enforcement, analysis of...more

The Volkov Law Group

Fresenius Pays $231 Million to Resolve Long-Standing FCPA Enforcement Action (Part I of III)

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Fresenius Medical, the largest supplier of dialysis equipment and services agreed to pay $231 million to the Justice Department and the SEC to resolve FCPA violations in 17 countries in Africa, the Middle East and Europe....more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Eighth Annual Pharmaceutical and Medical Device Seminar

On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....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

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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

Thomas Fox - Compliance Evangelist

Tribute to Hawking: Black Holes Everywhere

Holmes was one of the most famous women to come out of Silicon Valley. She founded Theranos, hyped the fraudulent blood testing scam and became for a short time a billionaire. Now all of that is gone, gone, gone. ...more

The Volkov Law Group

Anti-Corruption Risks and Drug and Device Companies

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For years, the Justice Department and the Securities and Exchange Commission touted the FCPA “sweep” of the pharmaceutical and medical device industries. With good reason, DOJ and the SEC turned the drug and medical device...more

Baker Donelson

Update on Regulatory Compliance in the Global Health Care Industry

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A comprehensive understanding of the constantly evolving layers that make up federal anti-corruption statutes, sanctions regulations and export control restrictions is imperative for both the pharmaceutical and health care...more

The Volkov Law Group

The FCPA Enforcement Run Continues into 2017

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Just when we thought 2016 was over and we could all breathe a sigh of relief, DOJ and the SEC have continued to run with a string of new enforcement actions. To all of those prognosticators, paparazzi, commentators, chicken...more

The Volkov Law Group

Badda Bing, Badda Boom!! — DOJ and SEC Make 2016 a Record Year for FCPA Enforcement (Part I of III)

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We begin the New Year with a three-part series on the FCPA: (1) A review of FCPA enforcement in 2016; (2) Trends from 2016 FCPA enforcement; and (3) Predictions for FCPA enforcement in 2017....more

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