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Life Science Compliance Update
Are We Seeing the End of OPDP?
The FDA OPDP issued enforcement letters have been on a steep decline since 2010. This article examines the numbers of OPDP letters…
The Dilemma of Co-Pay Charities and Patient Access to Medication
Increasingly creative methods are being used by big pharma to increase sales. Drug manufacturers are donating billions of dollars…
Retaliation, Pre-taliation, and Whistleblower Hotlines: How Compliance…
Handling whistleblowers is one of the biggest challenges facing most compliance officers. Furthermore, recent actions taken by the…
Tracking Towards a Banner Year for FCPA and FCA Enforcement
There are some strong indicators to suggest that 2016 is on track to be a real banner year regarding Foreign Corrupt Practices Act…
GSK & China – The Latest FCPA Settlement Isn’t the End
GlaxoSmithKline (“GSK”) reached a settlement with the Chinese government in 2014 related to bribes and improper actions taken by…
Examining the FY2015 Report on Medicaid Fraud Control Units
Medicaid Fraud Control Units play an important, if often overlooked, role in the Government’s continuing effort to control…
SEC Provides Explicit Whistleblower Guidance – Hunting Season Is Now Open
The SEC’s Office of the Whistleblower recently announced that its whistleblower awards have now exceeded over $100 million…
Value Based Contracts and Government Pricing
Value Based Contracts are becoming increasingly important and commonplace. VBCs also have important implications for Government…
Helping the Patient – Co-Pay Reimbursement Can Be Okay in Certain…
The OIG’s recent Advisory Opinion suggest that under certain circumstances patient co-pay reimbursement programs are allowable.…
The Blue Ribbon Panel Raises the Bar on Ethics & Compliance
According to the Ethics & Compliance Initiative (ECI), ethics and compliance programs should not be “check the box programs”…