Policy & Medicine Compliance Update
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JANUARY 2019 Issue
Issue Summary:
Happy New Year everyone! This month we thought it appropriate to take a step back and examine the evolution of compliance programs and what the future might hold. We also take a detailed look at the revisions to the Common Rule and the implications for all research. Next, we dive into successor liability both from FCPA perspective as well as Medtronic’s recent AKS settlements. Finally, we round out the month with a look once more at Commercial Free Speech and its limits as articulated in U.S. v. Harkonen.
FEATURE
COMPLIANCE PROGRAM OPERATIONS
Winning the Innovation Race – Can Compliance Programs Evolve Quickly Enough?
By Kristin Rand, Vice President and Compliance Officer, Seattle Genetics, (history provided by Dr. Seth B. Whitelaw, Policy & Medicine Compliance Update Editor)
Summary: Just like the rest of business, compliance officers and their staffs must continually innovate and adapt to keep pace and to remain useful. Absent flexible thinking, continual learning, and a desire to experiment, the compliance program can easily become a dinosaur. TAGS: Innovation, history, design, federal sentencing guidelines,
Research
Knowing the New Common Rule – It Is Not Just for Government Funded Research
by David Vulcano, LCSW, MBA, CIP, RAC, Vice President, Research Compliance & Integrity, HCA Healthcare
Summary: Revisions to the Common Rule (45 C.F.R. part 46) are slated to take effect on January 22, 2019 after seven years of work. However, since the Common Rule impacts more than just government-funded research, compliance officers in life sciences organizations should take note of this long-awaited update. Tags: Research, common rule, government funded research, clinical trials, informed consent
Successor Liability
Putting the Cart Before the Horse – DOJ Extends Self-Disclosure Protection to Successor Companies
By Robert N. Wilkey, Esq., Senor Staff Writer for Policy & Medicine Compliance Update
Summary: In August 2018, the DOJ extended its self-disclosure policy to successor companies, allowing voluntary self-disclosure protection for pre-acquisition violations of the target company. Despite the implementation of the DOJ’s self-reporting program, uncertainties remain, and it unclear what the future impact of the DOJ’s program will be. tags: Successor liability, doj, self-disclosure, fcpa
Caveat Emptor – Medtronic Settles Three Successor Liability Cases for $50.9 Million and a Guilty Plea
By Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Policy & Medicine Compliance Update
Summary: In December 2018, the Department of Justice announced three separate settlements with Medtronic PLC relating to actions taken by two of its subsidiaries prior to its acquisition of the companies. This article outlines the settlements, including the criminal conduct that one subsidiary pled guilty to as a misdemeanor charge. TAGS: Successor Liability, aks, criminal plea
Commercial Free Speech
U.S. v. Harkonen – A Look Back at the Limits of Free Speech in a Regulated Industry
By Carolyn Greene, Staff Writer, Policy & Medicine Compliance Update
Summary: The FDA has traditionally strictly prohibited drug manufacturers from promoting their drugs for off-label use. Many in the industry disagree with the FDA’s public health policy justification for this regulation, arguing that this position unconstitutionally restricts free speech. In a recent case involving allegations of off-label promotion, US v. Harkonen, the defendant unsuccessfully used such free speech arguments to defend statements regarding the off-label use of his company’s drug. tags: free speech, off-label, supreme court
