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Shifting Gears
Recent news accounts have been replete with large corporate settlements for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Some corporate plea arrangements and deferred prosecution agreements require companies to accept responsibility and pay a large fine. However, their officers are not prosecuted. That is changing, especially in the healthcare and pharmaceutical context. Increasingly, the focus is on senior executives who, under 21 U.S.C.
” 331 and 333(a)(1), can be held strictly liable as “responsible corporate officers” for the actions of persons under their supervision. The responsible corporate officer (RCO) doctrine is now forming the basis for significant civil and administrative ramifications.
The Park Doctrine
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