International Trade General Business Health

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Put the Candle Back: the AstraZeneca FCPA Enforcement Action

I am back from a two-week summer study program at Oxford, run by Michigan State University through its Odyssey to Oxford program. It was a great experience. My class was on The Tudors in film and print so not only did I...more

Lessons Learned from AstraZeneca’s $5.5 Million SEC FCPA Settlement

Last week, the SEC added another pharmaceutical company to its list of FCPA violators when AstraZeneca agreed to a $5.5 million settlement with the SEC. AZ is now the 25th drug or medical device company to pay an FCPA penalty...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

Changes in Cuba May Impact the Insurance Industry

While much remains to be determined, the recent easing of U.S. restrictions on travel to and trade with Cuba may bring opportunities for U.S. and global insurance companies. However, many questions and obstacles remain. This...more

Headlines from Mid-Year FCPA Enforcement Review

Just to add my voice to the cottage industry surrounding FCPA enforcement and compliance, I wanted to take a deep breath and offer some observations on FCPA enforcement in 2016. There are a few significant headlines...more

Colombian Organizations Send Letter to CEWG Regarding Imatinib Compulsory License

In letter from three Colombian organizations to the Chairman of the World Health Organization (WHO) 2016 Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) (posted on the...more

China Competition Authority Initiates Drug Pricing Investigation

On May 22, 2015, the National Development and Reform Commission (the NDRC) of China promulgated a notice (the Pricing Investigation Notice) announcing that it would carry out a nationwide drug pricing investigation on...more

Your daily dose of financial news The Brief – 4.11.16

The UK’s Daily Mail is reportedly joining Verizon in the field of suitors for Yahoo’s assets – WSJ - It’s no surprise when mega mergers attract the government’s attention, as we’ve seen in past weeks around here. But...more

Novartis FCPA Enforcement Action, Part II

Yesterday, I used a quotation from the Oscar winning animator, Chuck Jones who described two of his well-known creations, Roadrunner and Wily E. Coyote, by referring to philosopher George Santayana’s description of fanaticism...more

Novartis Coughs Up $25 Million to SEC for China FCPA Violations

Last week, the SEC announced another FCPA settlement involving the pharmaceutical industry for bribery in China. The SEC’s settlement filing represents yet another example of the pharmaceutical industry run amok in China,...more

Novartis FCPA Enforcement Action, Part I

The philosopher George Santayana is usually best remembered for the pithy saying, ‘Those who cannot remember the past are condemned to repeat it.” Santayana was an essayist, poet, professor and novelist. According to...more

Foreign Corrupt Practices Act Alert

Busy Q1 Yields Several Significant FCPA Resolutions - Overview - On February 19, during the US Securities and Exchange Commission’s (SEC) annual “SEC Speaks” conference, Kara Brockmeyer, Chief of the SEC’s FCPA...more

AGG Food and Drug Newsletter - March 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

New EU/US Privacy Shield Details Announced Program Includes Provisions for Pharmaceutical and Medical Products

On February 29th, the European Commission (the “Commission”) published the details of the new EU/US Privacy Shield program (“Privacy Shield”) which is intended to replace the EU/US Safe Harbor (“Safe Harbor”) program that was...more

The Olympus Debacle: Why Internal Whistleblowing is a Good Thing for Compliance

The U.S. Department of Justice announced last week that Olympus Corporation of the Americas (OCA) agreed to pay $646 million to resolve three cases relating to its longstanding practice to bribe doctors and hospitals in the...more

Cuba: The Risks and Rewards for U.S. Businesses

Background - Last week, the Obama Administration announced that the President intends to visit Cuba next month. He will find a political mixed bag of optimism and resignation. American businesses will find an equally...more

CHINA REGULATORY ENFORCEMENT QUARTERLY - Q4 2015

Legal and regulatory developments in Q4 2015 continue to reject attempts by the Chinese government to respond to the significant challenges presented by the slowing market economy and other domestic crises, while the country...more

Blood on the Tracks Hits No. 1 and the Lessons Learned from SciClone

On this week in 1975, Bob Dylan’s 15th studio album, Blood on the Tracks, reached the Number 1 album slot on the Billboard charts. This was in spite of no song rising above the 31st slot on the single charts. It came out in...more

The 37th International Conference of Data Protection & Privacy Commissioners – Some Observations

The annual conference of the world’s data protection regulators is a three day exercise, with half of the conference being “closed door” for the regulators only, and the other half being a series of side meetings and...more

FCPA Compliance and Ethics Report-Episode 210-Don Sinko, Chief Integrity Officer at the Cleveland Clinic [Video]

In this episode I visit with Don Sinko, the Chief Integrity Officer of the Cleveland Clinic, a world wide health care and health services provider. He talks about some of the challenges of ethics and compliance in such an...more

You Can Check Out Anytime You Want, But You Can Never Leave: FDA Import Detentions and Recommendations to Minimize Delays

In The Eagles’ song, “Hotel California,” Don Henley sings, “You can check out anytime you want, but you can never leave.” Life science companies can try to import all they want, but that doesn’t mean the products will make it...more

Trans-Pacific Partnership Has Challenges, Opportunities for U.S. Companies

The U.S. and its 11 negotiating partners – Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore and Vietnam – reached preliminary agreement on October 5, 2015, on the Trans-Pacific...more

Australia Biotech Week showcases sophistication and growth

On October 9, Australia's biotech community completed its annual pilgrimage to Melbourne at the conclusion of Australia Biotech Invest 2015 and AusBiotech 2015. This year's conferences once again evidenced the primacy and...more

Trans-Pacific Partnership: Compromise on Biologics Exclusivity Unclear

Earlier this month, a final agreement was reached on the Trans-Pacific Partnership that could provide for as little as five years of exclusivity for biologics. In recent months, it was reported that the biologics exclusivity...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

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