Life Science Compliance Update



September 2015: Life Science Compliance Update

Written by , Posted in September 2015 LSC Update, This Month in Compliance

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September 2015 LSCU Cover

The September issue of Life Science Compliance Update provides the life sciences industry with important news and analysis, covering:

* In-depth analysis on the implications of Amarin v. FDA
* Global Fair Market Value challenges
* International enforcement update
* Medicines Australia Transparency Code
* Update on UK bribery investigation

Issue Summary

The September issue of Life Science Compliance Update provides an important update on international compliance issues affecting the life sciences industry. The issue looks at global transparency initiatives, including the potential for new legislation in the United Kingdom, as well as updates to Medicines Australia’s disclosure requirements. We also provide an update on enforcement for bribery and other problematic promotion abroad, both from U.S. authorities and foreign authorities, such as in China.

Also in this month’s edition, Dakota Gallivan and Mario Prohasky of Polaris Management Partners contributed an article entitled “Global Fair Market Value and Its Challenges.” The article provides insight into the many considerations that go into an effective FMV program, from hourly rate development to implementation.

The issue also features an article that analyzes the implications of Amarin v. FDA, an important case that confirms a manufacturers First Amendment right to promote truthful off-label information about their products. Two authorities in this area contributed their insight to the article: Marc Scheineson, a former FDA Associate Commissioner and current partner at the Washington, DC law firm Alston & Bird where he heads the Food and Drug Law Practices, and John Kamp, the Executive Director of the Coalition for Healthcare Communication.

Table of Contents


Amarin v. FDA: What Are the Implications of Amarin’s First Amendment Victory?


UK Sunshine Act? Undercover Investigation Prompts Discussion of Mandatory Disclosure Law


Global Fair Market Value and Its Challenges

Dakota Gallivan and Mario Prohasky, Polaris Management Partners


Update From the Outback: Medicines Australia Releases Transparency Code, Includes Novel “Informed Consent” Policy


International Enforcement Update

  • Insight from the SEC on FCPA Priorities

  • Enforcement Abroad: China Continues Clampdown on Foreign Pharma Companies

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