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DEFENSE & GOVERNMENT CONTRACTING

Pharmaceutical advertising compliance

Pharmaceutical advertising compliance in Defense & Government Contracting sits at an unusual crossroads: contractors who manufacture, distribute, or procure pharmaceutical products for federal programs face scrutiny from both the U.S. Food and Drug Administration's Office of Prescription Drug Promotion and the U.S. Department of Defense's Defense Health Agency, which applies its own overlay of acquisition and formulary rules on top of FDA's promotional standards. The False Claims Act exposure alone makes this a serious liability vector for any defense contractor touching pharmaceutical supply chains or co-promotion arrangements under government contracts.

Watch

  • FDA OPDP untitled and warning letters citing fair balance failures in government-adjacent promotional materials
  • Defense Health Agency formulary compliance requirements affecting contractor-supplied drug promotion
  • False Claims Act enforcement patterns tied to off-label promotion in federal healthcare programs
  • Federal Acquisition Regulation Part 31 cost allowability rules for pharmaceutical marketing expenses
  • DoD contractor disclosure obligations when promotional claims conflict with approved labeling

Recent material activity in Defense & Government Contracting

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