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.