Policy & Medicine Compliance Update
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FEBRUARY 2020 Issue
Issue Summary:
As we highlighted in our January issue, 2019 was a landmark year for compliance. This month we feature the second part of the 2019’s Top 10 Compliance Milestones, and what they mean for 2020. Katherine Norris and Jennifer Vondee continue their detailed analysis of the remaining Top 10 developments.
For the remainder of this month’s Update, Gwendoly Ball takes another look at the Granston memo’s impact on False Claims Act qui tam cases, and why the Supreme Court and Congress may need to step in . Next, Kaitlin Fallon looks at the recent antitrust case against Sun Pharma and Ranbaxy. Finally, Carolyn Greene examines the current privacy landscape in the context of consumer genetic testing in light of GSK’s recently announced partnership with 23 and Me.
FEATURE
Looking Back on a Landmark Year: 2019’s Remaining Top Ten Compliance Milestones (and what they mean for 2020)
By Katherine Norris and Jennifer Vondee
Summary: 2019 was a watershed year for ethics and compliance. This article identifies the ten most significant events of 2019 and assesses the remaining five topics relative to their implications for 2020 and beyond.
TAGS: 2019, TOP TEN, Compliance Milestones
Litigation – Qui TAM Cases
DOJ v. Whistleblowers – Evaluating the Application and Future of the Granston Memo
By Gwendolyn A. Ball, Staff Writer
Summary: First announced in November 2017, the Granston Memorandum appeared to signal a change in the Justice Department’s attitude and policy towards False Claims Act qui tam cases. There is now general agreement that there has been an “uptick” in DOJ dismissals, and the courts have generally supported the DOJ’s power to dismiss actions in which it does not intervene. Consequently, congressional supporters of the role of whistleblowers in the oversight of federal programs are now questioning the DOJ’s policy. Thus, questions remain, and it will likely require the U.S. Supreme Court and now Congress to resolve them.
Tags: False Claims, Qui Tam, Dismissals
Enforcement
Antitrust, FDA & Sun Pharma – The Suit Goes On
By Kaitlin Fallon Wildoner, Esq., Senior Staff Writer
Summary: In November 2019, a federal district judge in Massachusetts ruled that the MDL antitrust lawsuit can continue against Sun Pharmaceutical Industries, Ltd. and its subsidiary, Ranbaxy, Inc. This article outlines the lawsuit and the judge’s decision to allow the claim to move forward.
TAGS: Antitrust, sun pharma, Ranbaxy, Fda
PRIVACY
Genetic Testing and Privacy – The New Frontier of Patient Engagement
By Carolyn Greene, Staff Writer
Summary: GSK recently announced a partnership with 23andMe, a consumer genetic testing service, to mine 23andMe’s huge database of genetic information. This partnership highlights how technology has evolved faster than privacy laws in this space.
TAGS: Privacy, genetic testing, 23andme, GSK, Consumers
