Policy & Medicine Compliance Update
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Summary: Like 2019 and 2020 before it, 2021 was an extraordinarily busy year for life science compliance professionals. Although a few new focus areas emerged, most critical developments aligned with previous trends from 2019 and 2020. We expect 2022 will be another active year with multiple challenges facing the industry and its compliance professionals. We also believe that it is essential for companies to make investments in their compliance functions to weather the unrelenting onslaught of external scrutiny amidst rapidly evolving industry practices—mainly driven by an evolving health care ecosystem.
Litigation & Enforcement
Chaos in the Courts
Two Crucial 340B Topics Dominate the Federal Courts
By Gwendolyn A. Ball, J.D. Ph.D., Staff Writer and Dr. Seth B. Whitelaw, Editor
Summary: The 340B program is currently enmeshed in litigation. Pharmaceutical companies and HHS are litigating whether the agency has the authority to allow hospitals to distribute 340B drugs through contract pharmacies. Meanwhile, participating hospitals are suing CMS over the decision to lower the reimbursement rate for 340B drugs. The latter case is particularly relevant for compliance professionals, having risen to the Supreme Court as a potential test of Chevron deference.
Off-the-Air for Good
Pharma Bro Martin Shkreli Loses to the FTC
By Robert N. Wilkey, Esq., Senior Staff Writer
Summary: In January 2022, U.S. District Judge Denise Cote issued an extensive opinion upholding an FTC injunction against “Pharma Bro” Martin Shkreli, including a lifetime industry ban. Shkreli and several co-defendants were found to have engaged in various anticompetitive actions and unfair trade restraints to block generic competition for the life-saving pharmaceutical Daraprim. Unfortunately, anticompetitive behavior continues to be a hallmark of the pharmaceutical industry that will require renewed efforts of life science compliance professionals to eradicate.
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.
Wishing you all the best,
Dr. Seth B. Whitelaw
Editor