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DOJ Memo Limits the Use of Agency Guidance in FCA Enforcement

Client Alert | 1 min read | 02.22.18

A recent memorandum issued by Associate Attorney General Rachel Brand (Brand Memo) prevents Department of Justice (DOJ) civil litigators from relying on agency guidance documents to demonstrate violations of the False Claims Act (FCA).  Specifically, the Brand Memo prohibits using noncompliance with agency guidance documents to presumptively or conclusively establish violation of the underlying law or regulation.  The Brand Memo references an earlier memorandum issued by Attorney General Jeff Sessions (Sessions Memo) that prohibits DOJ agencies from creating binding standards in guidance documents without engaging in notice-and-comment rulemaking.  The Brand Memo reiterates the core premise of the Sessions Memo – that guidance documents cannot create legal obligations.  It also expands on the Sessions Memo by directing DOJ litigators to apply that premise when interpreting other agencies’ guidance documents in civil enforcement actions.  While DOJ litigators may continue using agency guidance for “proper purposes,” such as to establish that a party had the requisite knowledge of a legal mandate because the party was familiar with a guidance document that explained it, this new policy represents a distinct limitation on the use of agency guidance in FCA enforcement.    

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Client Alert | 2 min read | 09.18.25

FDA Announces Intention to Initiate an Aggressive Enforcement Campaign Against Misleading Pharmaceutical Advertising

On September 9, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (HHS) issued a news release announcing an “aggressive[]” “crackdown” on direct-to-consumer pharmaceutical advertising. This release came on the heels of a Presidential Memorandum President Trump issued the same day directing HHS to “ensure transparency and accuracy in direct-to-consumer prescription drug advertisements,” and the FDA to “take action to enforce legal requirements that advertisements for prescription drugs be truthful and not misleading.”...