Life Science Compliance Update



November 2015: Life Science Compliance Update Volume 1.9

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The November issue features an article on the latest qui tam case involving Takeda, which breaks new ground as the plaintiff is a customer as well as an investigative author.  Nicodermo (Nico) Fiorentino, Senior Advisor, Research & Compliance, for G&M Health LLC., contributed a great roundup on the EU Data Privacy and the impact of the invalidation of the US-EU Safe Harbor Framework.  We also take a look at the state of medical device preemption after the case of Caplinger v. Medtronic, Inc., and delve into the muddy waters of FDA’s social media guidance.

Finally, in a new section called the Editor’s Corner, our new editor, Seth Whitelaw reflects on what it takes to find and engage a good life sciences compliance officer.

To view the table of contents for this issue, click here.



September 2015: Life Science Compliance Update Volume 1.7

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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.

To view the table of contents for this issue, click here.



April 2015: First Issue of Life Science Compliance Update

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On Monday, April 6, and on the first Monday of each month going forward, we will publish the latest issue of Life Science Compliance Update. This issue covers the latest enforcement trends coming out of the Department of Justice, a comprehensive update on HHS-OIG activity, and a thorough breakdown of important state transparency laws and new state bills that could have a big impact on life science companies.

The featured article in April’s issue provides the most comprehensive review of states’ “Right to Try” acts available. David Vulcano, industry regulatory expert and the Responsible Executive for Clinical Research at HCA, the nation’s largest private healthcare provider, has analyzed eleven states’ Right to Try laws, and compared and contrasted them in clear, concise charts. His article also analyzes other regulatory requirements and market forces that could affect the impact these state laws have on fulfilling their ultimate goal: to provide treatments quickly to terminally ill patients.

To view the table of contents for this issue, click here.



Sample Issue of LSC Update: A Look Back On A Busy 2014

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The sample issue of Life Science Compliance Update looks back on what was a busy 2014 for the pharmaceutical and device industry.

On the enforcement front, the Department of Justice was very active negotiating settlements involving kickback allegations. We look at the government’s activity in this space. The Physician Payments Sunshine Act was also a priority for the life science industry in 2014—this issue examines the rocky roll-out, the Open Payments data, and CMS’s often confusing interpretation of the continuing medical education reporting requirement. In keeping with the increasingly global nature of transparency, we also provide a useful resource for compliance with the EFPIA Disclosure Code. Finally, this issue provides an overview of three central antitrust issues facing the pharmaceutical industry, including the latest cases and legislation affecting competition.

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