May 13, 2021

Volume XI, Number 133

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Regulatory Disputes With HHS: When to Negotiate and When to Litigate [VIDEO]

For healthcare and life sciences companies, regulatory disputes with the US Department of Health and Human Services (HHS) and its operating divisions can present significant economic costs and reputational risks. Efficient resolution of such disputes is always preferable and requires a thorough grasp of both the law and the institutional relationships among the relevant HHS operating divisions, other parts of the Executive Branch, and agency personnel. When a company cannot reach an efficient resolution through negotiation and litigation is the only option, the company must vindicate its rights in a principled way that mitigates reputation risks.

In this webinar, McDermott partners Brian R. Stimson and Brian J. Malkin draw on their backgrounds with HHS and the US Food and Drug Administration, respectively, to help in-house healthcare and life sciences lawyers successfully navigate regulatory disputes with HHS and its operating divisions. Read on for select highlights from this insightful discussion.

  1. The Administrative Procedure Act (APA) sets out the operating principles around which HHS is organized and gives litigators a lens through which they can assess agency efforts to implement policy. Among other things, the APA defines the parameters and procedures for bringing an action against the agency.

  2. Stakeholders generally have the best chance of successfully litigating under the APA when they can challenge an agency action as contrary to the law. “Once you veer into the agency’s deference in interpreting the law, or the agency’s deference in administering a statute, it becomes very difficult under the APA to prevail, because the agency is deemed to have expertise and is deemed to act in good faith,” Stimson said.

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© 2021 McDermott Will & EmeryNational Law Review, Volume XI, Number 99
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About this Author

Brian R. Stimson Corporate Healthcare Litigation Attorney McDermott Will & Emery Law Firm
Partner

Brian Stimson is the former Acting General Counsel and Principal Deputy General Counsel (second-ranking lawyer) for the US Department of Health and Human Services (HHS) in Washington, DC. He represents health and life sciences clients in litigations, arbitrations and government investigations nationwide. As part of his practice, Brian counsels clients on how to navigate complex disputes that present overlapping legal, regulatory, public policy and business considerations. His collaborative and pragmatic approach draws on his work as a high-level HHS official and a...

1 202 756 8477
Brian J. Malkin Biotech Lawyer McDermott Will & Emery Law Firm
Partner

Brian Malkin counsels pharmaceutical and biologic clients on Food and Drug Administration (FDA) regulatory matters and intellectual property (IP) law, with an emphasis on patent litigation. His practice at the intersection of FDA- regulated products and patent law makes him a valuable partner to drug manufacturers, biotechnology clients, medical device companies and cannabis companies as they develop new products and protect their innovations though life cycle management, bring their products to market and pursue transactional opportunities.

...

202-756-8045
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