Policy & Medicine Compliance Update
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For November, we begun our coverage by examining a recent California Superior Court ruling that potentially could reconfigure the familiar landscape of product liability. Under the ruling, pharmaceutical manufacturers arguably can be liable for not pursuing known, safer alternatives to existing approved products.
Next, we examine the latest decision from the Fourth Circuit applying the Safeco decision to False Claims Act cases. However, despite the lack of a circuit split, the U.S. Supreme Court is reviewing the matter and thus the outcome is unclear.
Shifting gears, we explore the latest Medicare drug price negotiation developments authorized under the Inflation Reduction Act. The Centers for Medicare and Medicaid Services recently announced a new organizational structure, but potential pharmaceutical industry challenges threaten to delay or even derail the process.
This month we also discuss the need to rethink compliance education. Although clearly important, there are a host of challenges facing the delivery of high-quality learning programs.
Finally, we revisit an article from the October 2016 issue that remains relevant in 2022. The topic involves the Justice Department’s views of NPAs and DPAs, and we examine the landscape in 2016 together with the most recent policy updates.
Articles
FEATURE
Sharp Curve Ahead
Holding Pharmaceutical Companies Liable for “Non-Defective Drugs”
By Robert N. Wilkey, Esq., Senior Staff Writer and Dr. Seth B. Whitelaw, Editor
Summary: In denying motions for summary judgment, the California Superior Court has constructively held that drug manufacturers can be liable for arguably “non-defective” drugs. The case, now on appeal, has prompted several notable amicus briefs from industry and other business stakeholders.
Tags: Product Liability, Gilead, WLF, U.S. Chamber of Commerce, Amicus Briefs, California Superior Court, “Non-Defective” Drugs
LITIGATION & Enforcement – False claims
Simple in Concept; Difficult in Practice
Fourth Circuit Adopts Safeco Standard for False Claims Cases
By Dr. Seth B. Whitelaw, Editor, and Kaitlin Fallon Wildoner, Esq., Senior Staff Writer
Summary: Recently, an en banc panel of the Fourth Circuit Court of Appeals upheld the application of the Safeco willfulness standard in FCA cases and further clarified what “authoritative guidance” means in the context of that standard. The issue is now before the U.S. Supreme Court, whose decision will have important implications for future healthcare FCA cases.
Tags: Kickbacks, False Claims, scienter, state of mind, Supreme Court, Grassley, Amicus Brief, Scienter, Safeco, SuperValu, Congress, fourth circuit
LEGISLATIVE UPDate – inflation reduction act
Now the Hard Work Begins
CMS Begins Implementing the Inflation Reduction Act
By Gwendolyn A. Ball, Staff Writer
Summary: Now that the IRA has passed, the hard work of implementing the drug negotiation provisions begins. Implementation is well underway at CMS, but potential legal challenges threaten to make the process even more complicated.
TAGs: Inflation Reduction Act, Drug Pricing, Medicare, Price Negotiations, Rebates, CMS, Medicare drug rebate and negotiations Group, litigation, fifth amendment, eighth amendment, supreme court
Governance & Operations – education
The Need for Precision
Rethinking Compliance Learning, Education, and Training
By Kirt Kraeuter, Staff Writer
Summary: In the aftermath of the COVID-19 pandemic, compliance learning, education, and training is increasingly important. However, delivering high-quality learning presents a significant challenge for even the best-resourced compliance program. Thus, it is essential that compliance professionals rethink how compliance learning can be improved.
Tags: learning, education, training, soft-skills, universities, business school, executive educaton, compliance education, Federal Sentencing guidelines, DOJ Guidance
retrospective
October Flashback
A Look at What We Were Discussing in 2016
By Dr. Seth B. Whitelaw, Editor
Summary: Back in 2016, Policy & Medicine Update covered the Justice Department’s views on NPAs and DPAs. Now six years later, we have reprinted that article and re-examined it in today’s context.
Tags: NPA, DPA, DOJ, Corporate Criminal Advisory Group, Monaco, Polite, Criminal Enforcement Policies, Accountability
From all of us here (virtually) at Policy & Medicine Compliance Update, we hope all our readers and their families are safe and healthy. And as always, thank you for subscribing and for your continuing support in making us the most comprehensive, up-to-date compliance publication for life science compliance professionals.
Wishing you all the best,
Dr. Seth B. Whitelaw
Editor