FCPA Compliance and Ethics Report-Episode 121-FCPA Year in Review, Part II
FCPA Compliance and Ethics Report-Episode 82, continued fallout from GSK in China
FCPA Compliance and Ethics Report-Episode 15-GSK in China: a Game Changer in Compliance
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
About the PTAB Life Sciences Report: We will periodically report on developments at the PTAB involving life sciences patents. Abbott Laboratories v. Edwards Lifesciences Corp. PTAB Petition: IPR2020-00480; filed January...more
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
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
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 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 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
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
GlaxoSmithKline (GSK) announced that it is partnering with Verily Life Sciences LLC to form Galvani Bioelectronics. According to the press release, GSK and Verily will contribute IP rights and an investment of $712.7 million...more
Welcome to March's edition of our EU & Competition Law Bulletin covering recent legal developments impacting upon you and your business: - ..United Kindgdom: Large pay for delay fine imposed by CMA. ..Germany and...more
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
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
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
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
Ed. Note-this article is one of a continuing series of interviews of thought leaders in FCPA, Bribery Act and anti-corruption/anti-bribery. In this blog post, I interview Amy Sommers, partner in the Shanghai office of K&L...more
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
What is a sweep? It is certainly a well-known and relevant term in the sporting world....more
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
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
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
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