"FDA Posts Criteria For Targeting Individual Execs As "Responsible Officers"

Article preview from "The Gray Sheet" - February 7, 2011

Almost a year after signaling its intent to target more executives with misdemeanor prosecutions when their companies have broken the law, FDA has published its criteria for pursuing such cases.

"FDA Posts Criteria For Targeting Individual Execs As "Responsible Officers"

Article preview from "The Gray Sheet" - February 7, 2011

Almost a year after signaling its intent to target more executives with misdemeanor prosecutions when their companies have broken the law, FDA has published its criteria for pursuing such cases.

The criteria, which make up a newly added section of the agency's "regulatory procedures manual," include a handful of factors that may drive FDA to recommend that federal attorneys go after individuals rather than just a corporation when Federal Food, Drug and Cosmetic Act violations are alleged.

Among the considerations: the individual's position and authority within a company; whether a violation is likely to have harmed the public; the obviousness of the violation; and more practical-minded considerations like "whether the proposed prosecution is a prudent use of agency resources."

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