Policy & Medicine Compliance Update
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JULY 2019 Issue
Issue Summary:
For July, we are featuring a thought-provoking piece by Patrik Florencio and Donna Boehme discussing the future of pharmaceutical compliance profession. In addition to examining the history and evolution of the profession, the authors argue that it needs to transform itself from being simply compliance-based to a broader risk-based profession. We also take an in-depth review of the recent cases of Insys Therapeutics and Indivior PLC to examine what are the important compliance lessons from each that transcend the opioid crisis. Finally, we examine the recent Supreme Court case on the statute of limitations for False Claim Act cases and what it signals for the future of qui tam litigation.
FEATURE
Rethinking the Pharma Compliance Profession: Where Should We Go from Here?
By Patrik Florencio & Donna Boehme
Summary: The pharmaceutical compliance profession has reached an important crossroads. This article examines how the profession was born, how it has evolved, and why it should transform from a narrow compliance-based department into a broad risk-based profession.
TAGS: Operations, Risk, Compliance
ENFORCEMENT
Transcending the Opioid Crisis – Insys as a Compliance Cautionary Tale
By Carolyn Greene, Staff Writer
Summary: Insys Therapeutics recently filed for bankruptcy following a settlement with the DOJ regarding its sales and marketing practices related to its fentanyl sublingual spray, Subsys. In addition, four senior executives, including the Insys founder, were convicted of conspiracy and racketeering charges related to those sales practices, and two other senior executives previously pled guilty. The DOJ investigation, which began as five separate qui tam FCA cases, reveals that poor company culture and a pattern of systemic compliance failures ultimately can result in a company’s demise.
TAGS: Opioids, Bankruptcy, Subsys, Qui Tam
Transcending the Opioid Crisis II – Indivior As Another Case Study
By Robert N. Wilkey, Esq., Senior Staff Writer for Life Science Compliance Update
Summary: On April 9, 2019, a federal grand jury sitting in Abingdon, Virginia, indicted Indivior Inc. (“Indivior”) for engaging in an illicit nationwide scheme to increase prescriptions of Suboxone Film, an opioid drug used in the treatment of opioid addiction. However, the case is more than just another opioid enforcement and is another important case study for life science professionals to review.
TAGS: Opioids, Suboxone, Reckitt, Suboxone, FDA, Promotion
Litigation
Caveat Emptor – The Supreme Court Upholds an Extended Statute of Limitations for FCA Related Cases
By Robert N. Wilkey, Esq., Senior Staff Writer for Life Science Compliance Update
Summary: The U.S. Supreme Court case of Cochise Consultancy, Inc., et al. v. U.S. ex rel. Hunt, determined that relators can in certain limited circumstances file cases for conduct allegedly violating the FCA ten-years after the fact. Although the net effect of such ruling from the High Court remains to be seen, the Cochise case represents a clear legal win for FCA whistleblowers and life science companies should take note.
TAGS: Statute of Limitations, False Claims, Qui Tam, Supreme Court
