Justice Department expands fraud enforcement to target drug and device manufacturers
The U.S. Department of Justice issued a new directive that adds the Federal Food, Drug, and Cosmetic Act to its fraud-combating toolkit, signaling a broader focus on pharmaceutical and medical-device companies.
In a recent warning, the DOJ’s National Fraud Enforcement Division released guidance that now treats violations of the Federal Food, Drug, and Cosmetic Act as fraud offenses. Historically, the division concentrated on health-care providers such as clinics and hospices. By explicitly naming drug and device makers, the agency is widening its jurisdiction. Kevin Lowell, a former deputy chief of the division and now with Miller & Chevalier, described the move as a subtle but important shift.
Why it matters
The directive could lead to more criminal investigations of pharmaceutical and device makers, affecting industry practices and consumer safety.
In this story
