Review Outlines Critical Need to Integrate Effective Compliance Controls in the Ongoing Opioid Settlements

When Money and Doritos Don't Suffice - The Crucial Imperative for Integrating Effective Compliance Controls in the Ongoing Opioid Settlements.

​​​​​The current U.S. opioid epidemic has been branded as “the worst drug crisis in America’s history” and a “man-made plague.” According to the Centers for Disease Control and Prevention (“CDC”), the current public health crisis has claimed more than 351,000 lives to opioid overdoses since 1999 with no end in sight. The crisis also has generated an enormous amount of federal, state, and local litigation, much of which is ongoing, and involves many of America’s largest pharmaceutical manufacturers, distributors and retail chain pharmacies.

As the settlements and verdicts continue rolling in, Dr. Seth B. Whitelaw examines these settlements and verdicts in his latest article, When Money and Doritos Don’t Suffice – The Crucial Imperative for Integrating Effective Compliance Controls in the Ongoing Opioid Settlements.

Featured in the October issue of the Policy & Medicine Compliance Update, Dr. Whitelaw writes that:

“If we accept the fact that there is not enough corporate liquidity to fund the critical actions required to stem the crisis (e.g., funding systemic addiction treatment or repaying local emergency response costs for opioid overdoses), and we acknowledge that at least the larger companies involved in the manufacture, sale, distribution and dispensing of opioid products cannot, and probably should not, be driven into extinction because of the greater harm it will cause, then we are left with the need to craft a solution that accepts full monetary recompense is not possible, and many of the former defendants in the opioid cases will continue to manufacture, sell, distribute, and dispense pharmaceutical products.”

Thus, he contends that “other controls and mechanisms are essential to address the prior inappropriate activities involving executives and employees of those defendants, which will continue operating in the aftermath of the settlements, trials, and appeals. While complex, the goal of establishing truly effective controls to curb these unwanted behaviors, decisions, and actions is achievable.”  However, at this moment, neither plaintiffs’ counsel, State Attorneys General, Federal regulators, or even judges are focusing on this aspect to achieve a potential comprehensive solution.

With more than 30 years working in the industry, Dr. Whitelaw started his career in life sciences compliance in 1993, encompassing a wide variety of roles from an in-house compliance officer (C.R. Bard, Inc., SmithKline Beecham NA, GlaxoSmithKline, and Misonix, Inc.) to an industry consultant (Deloitte). He currently serves as the editor for Policy & Medicine Compliance Update, while maintaining his own life sciences compliance advisory firm (Whitelaw Compliance Group, LLC), a Senior Fellow and Adjunct Professor of Compliance at Mitchell Hamline School of Law.   

The Policy & Medicine Compliance Update is a monthly publication providing comprehensive, up-to-date compliance information for pharmaceutical, biotechnology, and device manufacturers. Each issue covers important news and analysis from top compliance officers and healthcare attorneys across the industry. 

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Source: Policy and Medicine