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ISSUE SUMMARY:
In the Hot Seat Again
Two More Settlements and a New CIA for Novartis
By Kaitlin Fallon Wildoner, Esq., Staff Writer and Dr. Seth B. Whitelaw, Editor
Summary: Novartis recently agreed to two significant settlements and a new CIA that we believe will reshape industry practices. The cases also serve as an excellent case study for life sciences companies and their compliance professionals that wish to avoid a similar fate.
Litigation
Helping Patients or The Bottom Line?
The Regeneron Co-Pay Foundation Case
By Craig B. Bleifer
Summary: The Regeneron co-pay foundation case filed by the Department of Justice reveals detailed internal company documents and a story of a patient assistance program motivated by profit and “return on investment.” There is also evidence that the company understood that its relationship with a foundation was improper and that executives took steps to cover up that truth. The case will impact co-pay foundation relationships, legal issues on damages and individual liability, and implicates general compliance program principles
Agreement in Principle
Merit Medical & Its Whistleblowing Compliance Officer
By Kirt Kraeuter, Staff Writer
Summary: The Merit Medical settlement is another example of the medical device industry, drawing increased attention from the Department of Justice. However, equally important is the qui tam relator, who previously served as Merit’s Chief Compliance Officer, bringing comparisons to the Olympus Medical case in 2016.
Governance & Operations
Probing Below the Surface of Gift Bans
What Does Maine’s Experience Signal for Industry?
By Nicodemo Fiorentino, Associate Editor
Summary: Maine’s healthcare practitioner gift ban law has been in effect since 2017. However, it took until 2020 for the Maine Board of Pharmacy to finalize the implementing regulations. Maine’s experience is not unique, and the idea of banning gifts to HCPs is gaining favor. Also, depending on the outcome of the 2020 presidential election, we could see national gift. These developments could spell trouble for the drug and device industries if they fail to address the issue proactively.
It’s Time to Revisit Third-Party Monitoring
Taking a Fresh Look at Third-Party Bribery and Corruption Risks
ByBen Schein, Staff Writer
Summary: The DOJ & SEC are having an active year with regards to enforcing and issuing updated compliance guidance for the United States anti-bribery/anti-corruption laws, mainly targeting the same high-risk markets and business practices as in years prior. However, the U.S. regulators’ actions in 2020 also provide life sciences companies with a new level of clarity surrounding the Government’s expectations for compliance programs, especially as they relate to historically challenging areas such as successor liability in M&A deals. This year’s FCPA settlements thus far serve as a set of real-time case studies from which compliance leaders can gain important, up-to-date insights and points of reference for guiding their companies forward in developing markets.