The February 2016 issue of Life Science Compliance Update, available here (subscription required), explores the impact technology has on the world of compliance departments and their operations.
Issue Summary
This issue brings many outside voices to the fray, writing on a wide variety of topics, such as the new European Generic Medicines Association Code, a white paper issued by Seton Hall Law’s Center for Health and Pharmaceutical Law & Policy on the role federal and state agencies and their relationships with relators affect enforcement of off-label promotion rules, and AdvaMed’s new compliance app for mobile devices.
Table of Contents
In the Global Issues portion of the subscription, Editor Seth Whitelaw, Ph.D., and Staffer Mohamed Gorrafa, J.D., write up the new EGA Code and some of its novel tenets.
In the Enforcement section, Charles Sullivan, a professor of law at the Seton Hall University School of Law discusses the white paper mentioned above, which analyzes the role of federal and state agencies, and their relationship with relators in both direct and indirect enforcement of off-label promotion.
Some of the team at Huron Life Sciences collaborated on an article that gives five “thoughtful controls” to consider with your specialty pharmacy relationships.
Since this is a compliance publication, the “meat” of the issue focuses on compliance. Katherine Norris, the Director of the Berkeley Research Group goes through the history of CIAs, and some significant milestones that have been made along the way. Seth Whitelaw educates us on AdvaMed’s new app that was developed with the intention of facilitating understanding and use of the AdvaMed Code. James Bone, the Executive Director of TheGRCBlueBook.com, writes about the way smart systems are being used in the life science industry to reduce risk and solve complex problems. Lastly, Kaitlin Fallon, J.D., summarizes for readers a roundtable discussion that recently took place at the Sixteenth Annual Pharmaceutical Compliance Congress and Best Practices Forum on joint ventures and co-promotes and best practices from a compliance perspective.
This month’s transparency focus is presented by Timothy M. Moore, Esq., an attorney with Shook, Hardy & Bacon, LLP, and hypothesizes some possible reasons as to why even though the Sunshine Act allows for Civil Monetary Penalties (CMP), CMS has yet to bring a single CMP action.
Subscription
If you are interested in subscribing to the Life Science Compliance Update, annual individual subscriptions are available for $1,200.00, with multiple subscriber-based discounts available. For a limited time, new subscribers can get 15% off of their subscription with the code “CHARTER15.”