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Kevin Lowell Quoted on DOJ's Increased Scrutiny of FDA-Regulated Companies, including Drugmakers, in STAT

Subtitle
"Justice Department Targets Drugmakers in Crackdown on White-Collar Fraud"

STAT

Kevin Lowell discussed in STAT the Department of Justice's (DOJ's) new directive identifying the Federal Food, Drug, and Cosmetic Act (FDCA) as an enforcement priority in its efforts to combat white-collar fraud. Lowell described the move as "a subtle but significant expansion of their jurisdiction," explaining that it brings FDA-regulated companies more clearly within the National Fraud Enforcement Division's focus. He noted that "the directive brings into focus all of the FDA-regulated companies" and highlights a part of the healthcare industry that "has not previously been a focus." Lowell suggested the division may pursue cases involving misbranded medicines, kickbacks, and conduct that leads to false claims submitted to Medicare or Medicaid.