Regulatory Disputes with HHS: When to Negotiate and When to Litigate - McDermott Will & Emery

Regulatory Disputes with HHS: When to Negotiate and When to Litigate


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For healthcare and life sciences companies, regulatory disputes with the U.S. Department of Health and Human Services (HHS) and its operating divisions can present significant economic costs and reputational risks. Efficient resolutions of such disputes are always preferable and require an understanding of the law, the institutional relationships between the relevant HHS operating division and 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.

Arm in-house healthcare and life sciences lawyers with the knowledge they need to navigate regulatory disputes with HHS and its operating divisions. Learn from former senior government officials:

  • The basics of the governing legal framework, which is the Administrative Procedure Act
  • Best practices for dispute resolution through advocacy at the division level and department levels and through litigation
  • A Case Study: APA negotiation and litigation approaches with one key HHS operating division, the U.S. Food and Drug Administration (FDA)
  • Regulatory areas that may give rise to disputes in the Biden Administration

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12:00 pm – 1:00 pm EST

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