DOJ expands fraud enforcement to include drug and device makers under FD&C Act
The Justice Department's National Fraud Enforcement Division released a new directive aimed at combating white-collar fraud, highlighting violations of the Federal Food, Drug, and Cosmetic Act.
In the past, the agency has mainly pursued cases involving health-care providers, clinics, and similar entities. By specifically referencing the FD&C Act, it signals that pharmaceutical and medical-device companies may now be subject to heightened enforcement.
Legal analysts say the change represents a subtle but significant expansion of the DOJ's jurisdiction, prompting firms to reassess compliance and risk-management practices.
This writeup was produced by pharmadog from original reporting by STAT.
Original headline: “STAT+: Justice Department targets drugmakers in new directive on combating white-collar fraud”
read at STAT ↗
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