Policy & Medicine Compliance Update
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Issue Summary:
Not unexpectedly, our focus for May is on COVID-19 and how the pandemic is changing both operations and compliance in the pharmaceutical and medical device industries. We begin with a discussion of drug shortages, and old problem that may become more acute with the pandemic. Next, we discuss FDA’s new COVID-19 guidance for clinical trial sponsors and investigators.
From a Governance and Operations perspective, we have an article from John Auerbach, Michael Jelen, and Jenny McVey discussing tele-compliance as a practical strategy for dealing with enforced social distancing. We also have another article in our Back-to-Basics series by Eric Baim and Amanda Holst with Dovetail Consulting Group on ownership and accountability in the written standards ecosystem.
Finally, rounding out this issue, is a detailed look at industry “wins” by Novartis, Schering-Plough and Takeda in their kickback and false claims cases.
Articles
FEATURE
Drug Shortages – Long Term Problem Becomes an Emerging Crisis
By Gwendolyn A. Ball, Staff Writer and Dr. Seth B. Whitelaw, Editor
Summary: The U.S. drug supply has long suffered from period shortages of critical drugs resulting from lengthy international supply chains, lack of investment in quality control, and use of contract manufacturing. These same factors may contribute to shortages caused by the COVID-19 pandemic. Fortunately, widespread shortages have not materialized. However, supply chain improvements and the underlying economics of the pharmaceutical industry need to change to achieve lasting systemic solutions.
TAGS: COVID-19, PANDEMIC, SUPPLY CHAIN, DRUG SHORTAGES, FDA, MANUFACTURING,
RESEARCH
Continuing Medical Research in a Pandemic – FDA’s New Flexibility for Clinical Trials Will Help
By Gwendolyn A. Ball, Staff Writer and David Vulcano, Editorial Board Member
Summary: Like everything else, the COVID-19 pandemic has impacted existing and future clinical trials’ ability to be run pragmatically and in full regulatory compliance. FDA has issued guidance to assist with the continuity of clinical trials during the pandemic response period as well as provide some enforcement discretion for pandemic related deviations. After the emergency period is declared over, the enforcement discretion likely will be withdrawn. If so, trial requirements will return to the pre-pandemic normalcy, but many of the new practices enacted may need to remain.
TAGS: COVID-19, PANDEMIC, RESEARCH, CLINICAL TRIALS, FDA
GOVERNANCE & OPERATIONS
Compliance During a Crisis – Have You Incorporated Tele-Compliance into Your Business Continuity Plans?
By John Auerbach, Michael Jelen, and Jenny McVey, Ph.D.
Summary: As the world continues to navigate through the pandemic, businesses have put their business continuity plans into action. For many compliance functions, COVID-19 has exposed the need to operate more effectively in a virtual environment. Compliance program leaders should use this moment as an opportunity for long term strategic planning towards a next-generation operating model, if not already done. Therefore, compliance programs will need to identify technologies that enable better interaction with both the virtually connected people within and the vast stores of data generated by the modern enterprise. This article is first in a series on practical strategies for building a more virtual compliance function that captures the value of data in more effective ways.
TAGS: COVID-19, PANDEMIC, Business CONTINUITY, TELE-COMPLIANCE, OPERATIONS
Back-to-Basics – Driving Ownership and Accountability in the Written Standards Ecosystem
By Eric M. Baim, Managing Director, and Amanda Holst, Manager, Dovetail Consulting Group LLC
Summary: Written standards, such as policies and procedures, and their development process, are part of a broader, dynamic ecosystem consisting of Governance, Access, and Content, all of which drive cross-functional compliance ownership and accountability. This article focuses on those three features and includes case study examples of leveraging the written standards ecosystem to transform the compliance culture of three different organizations.
TAGS: GOVERNANCE, WRITTEN Standards, Back-to Basics, Transformation, Cross-FunctionaL
ENFORCEMENT
The Government Is Not Invincible – Novartis, Merck, Schering-Plough, and Takeda Avoid Kickback & False Claims Liability
By Kaitlin Fallon Wildoner, Esq., Senior Staff Writer
Summary: In late March and early April of this year, we saw rare legal “wins” for the pharmaceutical industry. Novartis AG had a whistleblower suit against it dismissed, and Merck, Schering-Plough, and Millennium all had a kickback suit dismissed for the third time.
tags: kickbacks, AKS, false claims, whistleblower, qui tam, merck, schering-plough, takeda, millennium, dismissal, ENFORCEMENT
