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Life Science Compliance Update
Europe Moves to the Next Level in Protecting Personal Data – The GDPR…
As cross-border business and technology advances, the European Union’s need to address data privacy protection continually rises.…
The Battle Over Patient Assistance Programs Heats Up
Patient assistance programs have been in the spotlight for the past few years as the drug pricing controversy comes to a head.…
“White Coat” Marketing Gone Awry
Achieving patient adherence to prescribed medication through clinical educator programs is not a new concept. Neither is the U.S.…
Fighting Back – Pharma Objects to FDA’s Last Minute Obama-Era Guidances
As we noted in last month’s issue, the FDA issued a slew of last-minute Obama Administration guidances. Overlooked among all the…
A Port in Any Storm – Adding New Safe Harbors to the Anti-Kickback Statute
On December 7, 2016, the HHS Office of the Inspector General ("OIG") approved new safe harbors to the federal anti-kickback…
Improving Outcomes – Analyzing a Compliance Training Curriculum to Reduce…
Life sciences compliance departments are under constant pressure to roll out updated and comprehensive training that addresses a…
The Financial Risk of Waiting – 340B, Duplicate Discounts and Diversion
The purpose of this article is to give manufacturers some initial background on the topics and some tools that could be…
Changing the Rules Again: The MedTech Europe Code & Third-Party…
Although the new code of conduct for member medical device and in-vitro diagnostic companies operating in the European marketplace…
Whack a Mole: Pricing Bills Keep Popping Up Everywhere
Over the last several years, the pharmaceutical industry has seen a steady increase in state legislation targeting the cost of…
The Murky Future of Physician Owned Distributorships (“PODs”)?
On January 9, 2017, a physician was sentenced for his role in a criminal health care fraud scheme totaling approximately $2.8…