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Life Science Compliance Update
Like the Little Drummer Boy, the Beat Goes on as OIG Enforcement Shows Few…
As life science compliance professionals know, it is important to monitor what the HHS OIG focuses on. This article reviews the…
A Compliance New Year’s Resolution – Assess the Company’s Culture
The topic of ‘company culture’ is certainly not new, but it continually emerges as a hot topic within regulatory circles. An…
Will Your Whistle Be Heard at Home?
The distinct split between the Second and Fifth Circuit Courts’ interpretation as to when whistleblower protections are allowed…
Getting Serious About Fraud – The DOJ Charges 412
With the new administration, there appears to be a renewed commitment to enforcing anti-kickback rules against healthcare…
UPDATE: Round 2 with Ohio’s Drug Sample Verification Requirements
In the September issue of the Life Science Compliance Update, the authors discussed the new Ohio drug distribution verification…
The Expanding Frontier – Commercial Interactions with Patients and…
Over the past two decades, the role that patients play in their health care has dramatically shifted. As a result, there is an…
Coming Soon to a State or Even City Near You – Part 1 Pricing…
As opposition to and concern about the activities of drug manufacturers continue to mount, increasingly states, and even cities,…
The Never-Ending Saga of Off-label Promotion
The concern of misbranded products leading to patient harm and potential fraud is inarguable. The FDA has held a long-standing…
Fresenius to the U.S. Government: When It Comes to the FCA, You Snooze You…
In a nearly decade long lawsuit involving the dialysis company Fresenius, and allegations that the company violated the False…
To Disclose or Not to Disclose… That is the Question: The DOJ’s FCPA Pilot…
It has been over one-year since the US Department of Justice has launched its pilot program aimed to incentivize companies to…