Policy & Medicine Compliance Update
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January 2021
Issue Summary:
We begin our first issue of the year with the first installment of a two-part series on the Top Ten compliance issues in 2020, and the potential implications for 2021.
This month we also focus on research. Beginning our look at research, we have an excellent, in-depth article from David Vulcano highlighting the complex world of data in the context of de-identified patient data, limited data sets, and data use agreements. Next, we turn to the issue of industry’s use of disqualified or debarred FDA clinical researchers that has resurfaced once again.
Finally, we close out our opening issue of 2021 with an in-depth examination of the latest OIG Special Fraud Alert that targets speaker programs.
Top Ten Compliance Issues of 2020 (Part 1)
COVID-19 Dominated 2020, but Compliance Developments Unfolded at Furious Pace
By Katherine Norris
Summary: In January 2020, we identified 2019 as a watershed year for the life sciences ethics & compliance profession based on the number and significance of the developments we observed in that period. In retrospect and compared to 2020, 2019 was the tip of the iceberg. This article is the first of a two-part series discussing the Top 10 compliance issues of 2020 and the potential implications for 2021.
Governance & Operations – Research
Back to Basics – The Complex World of Data
Understanding De-Identified Patient Data, Limited Data Sets, and Data Use Agreements
By David Vulcano, LCSW, MBA, CIP, RAC
Summary: Researchers often refer to a desired data set to be “de-identified” or “limited.” However, those words have strict regulatory definitions and thus take on a very different context when used in a regulated setting. By fully understanding and harmonizing with those definitions, researchers can decrease the cost, time, and risk in obtaining the data they need.
A Nightmare Scenario and Industry Black Eye
FDA-Disciplined Doctors Still Receive Industry Funding
By Kirt Kraeuter, Staff Writer
Summary: Two recent articles by Charles Piller in Science Magazine documented payments still flowing to physicians from pharmaceutical and medical device companies after FDA disciplinary actions and alleged that FDA disciplinary processes fail to correct substantial investigator conduct issues. While the articles suggest a primary cause is the industries’ incompetence or focus on bottom-line matters, the current situation is a more complex situation for nearly all parties involved.
Litigation & Enforcement
Speaker Programs in the Crosshairs
The OIG Issues a New Special Fraud Alert
By Kirt Kraeuter, Staff Writer
Summary: In November 2020, the OIG issued a Special Fraud Alert focused solely on speaker programs. The new guidance is a logical evolution of their thinking dating back to 1994 but updated to reflect lessons gleaned from numerous recent enforcement actions and settlements. The message for life sciences companies is that they either need to demonstrate the importance of speaker programs as legitimate educational services or consider abandoning them altogether.
From all of us here (virtually) at Policy & Medicine Compliance Update, we hope all our readers and their families are safe and healthy during these challenging times. And as always, thank you for subscribing and for your continuing support making us the most comprehensive, up-to-date compliance publication for life science compliance professionals.