DOJ Memorandum Addressing Agency Guidance

8 March 2018
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Key takeaways
  • In January, the Department of Justice (“DOJ”) released a memo that generally prohibits DOJ from relying on noncompliance with agency guidance documents to prove a defendant’s violation of applicable law in civil actions. In the past, agencies have used guidance documents as a means to circumvent formal rulemaking requirements.
  •  The DOJ memo may have particular significance for actions brought under the False Claims Act (“FCA”). The memo will likely reduce – if not eliminate – circumstances in which DOJ brings FCA cases that are predicated on failures to comply with agency guidance documents. In the past, agency guidance has factored prominently into cases involving the life sciences, healthcare and mortgage sectors. Instead, DOJ will have to prove failures to comply with the applicable statutes or regulations.
  •  The DOJ memo does not formally apply to criminal actions or to administrative enforcement actions. But the logic of the memo – that agency guidance documents cannot create binding obligations – should apply to all types of government enforcement actions.