Justice Department issues new directive targeting drugmakers for white-collar fraud
The U.S. Department of Justice issued a new directive last week to combat white-collar fraud by explicitly including pharmaceutical manufacturers under federal law.
Shift in enforcement focus
The National Fraud Enforcement Division previously concentrated on providers, clinics, and hospices. This latest directive expressly includes the Federal Food, Drug, and Cosmetic Act to regulate drug and device makers. Kevin Lowell of Miller & Chevalier described this move as a significant expansion of agency jurisdiction.
Legal basis for action
The agency will now pursue violations of the federal law that tightly regulates the pharmaceutical industry. This change places life sciences companies more clearly in the crosshairs of federal investigations. The directive serves as a direct warning to the life sciences sector.
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