The December 2015 issue of Life Science Compliance Update, available with a subscription here, offers a more in-depth look at several recent enforcement and legislation actions affecting the compliance world.
Issue Summary
In this month’s issue, you’ll find a thorough look at the enforcement activity against Warner Chilcott, as well as insight into enforcement issues on the horizon relating to the Government’s new push for individual accountability. The issue also features an article on the Yates Memo, with insight from Paul Kalb, of Sidley Austin, as well as how the DOJ, FBI, and OIG view it.
The issue also features an article on Sanofi’s Corporate Integrity Agreement, which was signed with no fanfare from the compliance community. We also hear from a panel of five Chief Compliance Officers what life is like after the CIA ends. Finally, we have updates on key First Amendment cases and the Prevor combination products case.
Table of Contents
Back to the Future Compliance Style
The Yates Memo: This seems all too familiar
The New Gilded Age of Individual Accountability – Views from the Enforcers
Sanofi (finally) signed their Corporate Integrity Agreement
How not to move the needle – Lessons from the Warner Chilcott Settlement
Bipartisan Budget Act Increases Civil Monetary Penalties
Speaking Frankly – Post CIA Insights from Five Chief Compliance Officers
FDA v. the 1st Amendment – The Saga Continues
Strike Two – HRSA’s 340B Orphan Drug Policy Struck Down Again
Allowing Industry to Decide Its Own Regulatory Fate? Evaluating the Long-Term Significance of the Prevor Case
Subscription
An annual individual subscription of twelve electronic issues is available for $1,200.00 U.S., with multiple subscriber-based discounts available. To learn more and purchase, visit www.lifescicompliance.com. A free sample issue is available for download by visiting www.lifescicompliance.com.