News & Analysis as of

Medical Devices Pharmaceutical Industry GlaxoSmithKline

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - March 2024

WilmerHale on

Calls for Removal of Device Patents Listed in the Orange Book Continue. FTC and Congressional action scrutinizing allegedly “improper” Orange Book listings continued apace in the first few months of 2024. ...more

Thomas Fox - Compliance Evangelist

Corruption in China: Part 3 – Red Flags

I continue with the multi-part blog post series based upon the New York Times (NYT) article by Alexandra Stevenson and Sui-Lee Wee, entitled “Selling CT Scanners with Bricks of Bills in China”, which details allegations of...more

Thomas Fox - Compliance Evangelist

Corruption in China: Part 2 – The Bribery Schemes

After a sidetrack into the ethical train wreck detailed by the SEC Cease and Desist Order re: KPMG yesterday, I am returning to the blog post series I am running based upon the New York Times (NYT) reporting by Alexandra...more

Baker Donelson

Update on Regulatory Compliance in the Global Health Care Industry

Baker Donelson on

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

Bass, Berry & Sims PLC

FCA Issues to Watch: Pharmaceutical and Device Developments | INSIDE THE FCA

Bass, Berry & Sims PLC on

The government’s FCA enforcement efforts have continued to focus on key areas concerning the pharmaceutical and medical device industries. In fact, drug and device manufacturers accounted for nearly half of the enforcement...more

The Volkov Law Group

GSK Settles SEC FCPA Case for $20 Million

The Volkov Law Group on

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

Thomas Fox - Compliance Evangelist

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

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - February 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

The Volkov Law Group

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

The Volkov Law Group on

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

Searcy Denney Scarola Barnhart & Shipley

Is Off-Label Drug Promotion Protected Free Speech?

It is a very common practice. Drug sales reps visit a client, usually a hospital, a clinic or a doctor, with the sole purpose of selling a drug or medical device. That is the primary way a doctor learns about a drug or...more

Thomas Fox - Compliance Evangelist

What Hath GSK Wrought? More Compliance Lessons From China

In an article, entitled “GSK China probe flags up wider worries”, in the Wednesday edition of the Financial Times (FT) reporters Andrew Jack and Patti Waldmeir discussed the ongoing bribery and corruption scandal involving...more

The Volkov Law Group

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

The Volkov Law Group on

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

Thomas Fox - Compliance Evangelist

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

The Volkov Law Group

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

The Volkov Law Group on

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

The Volkov Law Group

Bad News For The Drug And Device Industries: Glaxo’s Systemic Breakdown In China (Part I Of III)

The Volkov Law Group on

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...more

Mintz - Health Care Viewpoints

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

Patrick Malone & Associates P.C. | DC Injury...

Getting the Best Medical Care: a Newsletter from Patrick Malone - July 2013

In This Issue: - Is There a Problem? Let Us Count the Ways - A Growing Awareness - Getting Objective Information - Recent Health Care News You Should Know About - Excerpt from Navigating Through Medical...more

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