Life Science Compliance Update

November

2015

November 2015: Life Science Compliance Update

Written by , Posted in New This Month, November 2015 LSC, This Month in Compliance

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October 2015 LSCU Cover

Issue Summary

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.

Table of Contents

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Letter from the Editor

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Editor’s Corner: Reflections On Finding and Engaging a Good Compliance Officer

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Litigation: Takeda Qui Tam Breaks New Ground

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Data Privacy: Sailing with No Safe Harbor In Sight:  What is the Next Destination for US-EU Data Privacy?

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Medical Devices: Federal Preemption and Medtronic: The Seemingly Endless Merry-Go Round

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Social Media: A Journey Without End? FDA and Social Media Guidance

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Transparency: Academics On The Board – A True Problem Or A Hammer Looking For A Nail?

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Briefly Noteworthy

  • Who says crime doesn’t pay
  • Whistleblowing UK-style
  • Getting it backwards – guilty until proven innocent
  • Even the government cheats

April

2015

April 2015: First Issue of Life Science Compliance Update

Written by , Posted in Blog Post, Issue Archive, New This Month

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.

January

2015

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

Written by , Posted in Blog Post, Issue Archive, New This Month

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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