News & Analysis as of

White Collar Crimes › Federal Food Drug and Cosmetic Act (FFDCA) › Pharmaceutical Industry

Skadden, Arps, Slate, Meagher & Flom LLP

Core False Claims Act Theories Top the List of DOJ Criminal Enforcement Priorities

Skadden, Arps, Slate, Meagher & Flom LLP on

The May 12, 2025, memo from the head of the Department of Justice’s (DOJ’s) Criminal Division highlights 10 “high-impact” areas as the focus of DOJ’s criminal enforcement efforts. (See our May 14, 2025, client alert “In a New...more

Troutman Pepper Locke

Did Congress Intend to Criminalize Off-Label Promotion? One District Judge Suggests the Issue Is Ripe for Review

Troutman Pepper Locke on

A judge in the District of Massachusetts recently questioned whether Congress intended to criminalize off-label promotion through misbranding and adulteration statutes. In an order denying a Rule 29 motion brought by two...more

Cadwalader, Wickersham & Taft LLP

The Responsible Corporate Officer Doctrine in the Wake of DeCoster

Cadwalader, Wickersham & Taft LLP on

Executive Summary: The most important Park doctrine case in over forty years may be heading to the Supreme Court – but not if the federal government has its way. The Responsible Corporate Officer doctrine (“RCO doctrine”),...more

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