Policy & Medicine Compliance Update
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DECEMBER 2019 Issue
Issue Summary:
As 2019 draws to a close, our focus for this month’s issue is looking at the compliance profession. First, we start with a retrospective look at the major developments in life science compliance over the past 20 years. Then we examine the need for the profession to embrace social responsibility as part of its role.
Next, we look at an emerging risk involving the use of third-party conduit organizations by pharmaceutical companies. Rounding out the issue, we examine the beginning of France’s Mediator criminal trial and calls from the Washington Legal Foundation to reform the MDL process.
FEATURE
Turning 20 – A Retrospective Look at Life Science Compliance
By Dr. Seth B. Whitelaw and Nicodemo Fiorentino, Esq.
Summary: Adapted from a piece originally written for the 20th Annual Pharmaceutical and Medical Device Compliance Congress, we thought it was a good time for our readers to look back at the major developments in life science compliance since the first Congress was held in 2000.
TAGS: Compliance, Operations, History
OPERATIONS
Rethinking the Pharma Compliance Profession II: Moving Beyond Ethics, Compliance & Risk towards Social Responsibility
By Dr. Seth B. Whitelaw and John A. Murphy, Esq.
Summary: As the events of 2019 have shown, the pharmaceutical industry is under increasing pressure to broaden its focus beyond shareholders to better and more visibly include the interests of other stakeholders such as patients, employees, and communities. Accordingly, pharmaceutical compliance must broaden its focus too, by more robustly embracing social responsibility and incorporating its ethos within the traditional roles of ethics, compliance, and risk management.
TAGS: Operations, Risk, Compliance, Social Responsibility
Emerging Risk
Are Third-Party Conduits the Next Big Compliance Focus? – Senator Grassley & Others Think So
By Carolyn Greene, Staff Writer and Dr. Seth B. Whitelaw, Editor
Summary: While PAPs and independent patient co-pay charities have been the subject of AKS scrutiny for some time, Capitol Hill and the media have recently turned their attention to other financial relationships between drug manufacturers and third-party conduits, such as patient advocacy organizations. We believe third-party conduits represent the next big compliance challenge facing the industry.
TAGS: PAPs, Co-pay Charities, AKS, Third-Party
INTERNATIONAL
The U.S. is Not Alone: The Criminal Trial Begins in the French Mediator Scandal
By Gwendolyn Ball, Staff Writer
Summary: Like the U.S., France has experienced its share of scandals involving the pharmaceutical industry. This article examines the Mediator scandal and the recent commencement of the criminal trial involving government regulators and company executives
TAGS: France, Mediator, Criminal, Drug Safety
litigation
The Opioid Fallout Continues with a Call to Reform the Multi-District Litigation (“MDL”) Process
By Robert N. Wilkey, Esq., Senior Staff Writer, and Dr. Seth B. Whitelaw, Editor
The Washington Legal Foundation has proposed substantive reforms to the multi-district litigation (“MDL”) process in the United States. This article reviews the current MDL landscape and the Foundation’s comments in detail. Given that the MDL process has operated largely unchanged for many years, any efforts to foster a more merit-based, fair, and transparent MDL process will certainly have long-term legal implications.
TAGS: Opioids, MDL, WLF, Reform
