DOJ Expands Fraud Enforcement to Target Drugmakers — SkimNews
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- The Department of Justice issued a new directive last week on combating white-collar fraud, warning life sciences companies it will pursue violations of the Federal Food, Drug, and Cosmetic Act.
- The National Fraud Enforcement Division has historically pursued health fraud cases against providers, clinics, home health agencies, and hospices — and the directive signals a shift toward drug and device makers.
- Kevin Lowell, a former DOJ deputy chief in the NFED's health care fraud section who spent a decade at the agency and now practices at Miller & Chevalier, called the move "a subtle but significant expansion of their jurisdiction."
- The directive marks the first time the NFED has expressly included the Federal Food, Drug, and Cosmetic Act in its enforcement framework, placing pharmaceutical and medical-device companies more clearly in the agency's fraud crosshairs.
Why it matters: Drug and device manufacturers now face DOJ fraud scrutiny under a statute historically tied to product safety, not financial misconduct. A former deputy chief in the NFED's health care fraud section called the move a "subtle but significant expansion," meaning life sciences companies should expect closer review of FDCA compliance and potentially steeper penalties for violations that previously fell outside the division's focus.
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