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September 2018 Issue Summary
This month we begin with the fact that we have a new name. It is my great pleasure to announce that going forward the LIFE SCIENCE COMPLIANCE UPDATE is combining forces with POLICY & MEDICINE with a new name and eventually a new website. With a nod to both our past and our future, our new name is POLICY & MEDICINE COMPLIANCE UPDATE, and this change we are now are truly part of the P&M family. Therefore, let me welcome all of you to the inaugural issue of POLICY & MEDICINE COMPLIANCE UPDATE and to our bright future!
Building from last month’s article comparing compliance between the FINANCIAL SERVICES and LIFE SCIENCES, this month continue with PART II examining how banks ORGANIZE their COMPLIANCE FUNCTIONS.
On the enforcement front, we get a look at the potential increase in FCPA ENFORCEMENT as the DOJ expects more effort from SENIOR MANAGEMENT to combat bribery and corruption. Next, we look at the recent DOJ SUBPOENA for SANOFI around the marketing of MS DRUGS, followed by an article about the efforts to reform the 340B DISCOUNT PROGRAM by increasing TRANSPARENCY. Finally, not forgetting the importance of the plaintiff’s bar, we examine a novel plaintiff’s GENERIC PHARMACEUTICAL product LIABILITY theory called INNOVATOR LIABILITY.
By: Jenny McVey, Ph.D.
Tags: Banking, Compliance operations, Financial Services
By Michael Trahar
Tags: Criminal, Enforcement, FCPA, Third-party
By Carolyn Greene, Esq.
Tags: AKS, MS, Sanofi, Subpoena
By Gwendolyn Ball
Tags: 340B, Drug pricing, Transparency
By Kaitlin Fallon Wildoner, Esq.
Tags: Generics, Innovator liability, Plaintiffs, Products liability