Justice Department directive targets drugmakers in white-collar fraud enforcement
STAT News reports the Justice Department's new fraud directive names the Federal Food, Drug, and Cosmetic Act, a federal law that tightly regulates the pharmaceutical industry.
Key facts
- STAT News reported on 7 October 2026 that the U.S. Department of Justice had issued a new directive on combating fraud the previous week.
- According to STAT News, the directive notes the agency will pursue violations of the Federal Food, Drug, and Cosmetic Act, a federal law that tightly regulates the pharmaceutical industry.
- STAT News reported that the Justice Department's National Fraud Enforcement Division has typically pursued health fraud cases centered on providers, clinics, home health agencies and hospices.
- According to STAT News, expressly including the law in the directive appears to place drug and device makers, among others, more clearly within the division's enforcement scope.
- Kevin Lowell of the Miller & Chevalier law firm said: 'This is a subtle but significant expansion of their jurisdiction.'
STAT News reported on 7 October 2026 that the U.S. Department of Justice had issued a new directive on combating fraud the previous week. According to STAT News, the directive notes the agency will pursue violations of the Federal Food, Drug, and Cosmetic Act, a federal law that tightly regulates the pharmaceutical industry. STAT News described the directive as a warning to life sciences companies.
According to STAT News, the Justice Department's National Fraud Enforcement Division has typically pursued health fraud cases centered on providers, clinics, home health agencies and hospices. STAT News reported that by expressly including the Federal Food, Drug, and Cosmetic Act in the directive, the division appears to be placing drug and device makers, among others, more clearly within its enforcement scope.
Kevin Lowell, a member of the Miller & Chevalier law firm, said: 'This is a subtle but significant expansion of their jurisdiction.' According to STAT News, Lowell spent a decade at the Justice Department, where he most recently served as deputy chief of the National Fraud Enforcement Division's health care fraud section.
Context
The Federal Food, Drug, and Cosmetic Act is the federal law that regulates the pharmaceutical industry, according to STAT News. STAT News reported that the Justice Department's health fraud cases have typically centered on providers, clinics, home health agencies and hospices.
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