Monthly Archives: December 2012

SEC Charges Lilly with Corruption Abroad: A Taste of Fines to Come

The Securities and Exchange Commission filed charges on Eli Lilly and Co. yesterday for violations of the Foreign Corrupt Practices Act (FCPA) that allege the drug maker’s subsidiaries overseas bribed foreign officials in Russia, China, Brazil and Poland. The settlement totaled $29 million after an investigation of activities reaching as far back as 1994, assessed […]
Posted in Emerging Markets, Global, Legal, Regulatory | Tagged | 1 Comment

The Year to Come: EMA's Plans Announced

At the end of last month, the European Medicines Agency approved its budget and work program for the coming year, promising to implement measures to increase operational efficiency, enhance transparency and communication with stakeholders, and improve the quality and consistency of rulemaking. With a 4.1% increase in budget to €231.6 million and an anticipated 54 […]
Posted in Europe, Regulatory, Safety, Strategy | Tagged , , , | Leave a comment

Compliance and Legal Not Always Eye-to-Eye

As the role and stature of the compliance officer grows, legacy senior management structures and hierarchies can accidentally pit lawyers against one another. What is strictly legal in the context of sales and marketing practices, working with government officials in global markets, and running and reporting on clinical programs, may not always be the last […]
Posted in compliance, Corporate Responsibility, Legal, Marketing, Regulatory, Sales, Strategy | Tagged , , , , | Leave a comment

Saving Greece's Healthcare System: A Harbinger for Europe?

A just-published report from the European taskforce trying to help Greece crawl out of its crisis makes clear just how significant a role health reform is supposed to play in restoring health to the economy. It is, in a very acute form, a harbinger of what is around the corner for the other countries of […]
Posted in Europe, Global, Guest Blog, healthcare | Tagged , , , , , , | Leave a comment

Questions About the 2013 Implementation of IPAB

by Tom Norton With the general election behind us, the anticipated avalanche of ObamaCare regulations has begun.  Last week, it was reported that more than 13,000 pages of rules and regulations have been issued by HHS since Nov. 6th.   A huge amount of activity, to be sure, but as stated, not surprising.  That’s because the […]
Posted in FDA, healthcare, Legal, Market Access, pricing, Regulatory | Tagged , , , , , , , | Leave a comment
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