FDA: Cómo ir a la carcel...

The FDA has just released its long-awaited criteria for criminal prosecutions under the Park doctrine, which allows the government to seek a misdemeanor conviction against a corporate officer for alleged violations of the FDCA—even if the officer was neither involved in or even aware of the statutory violation. We’ve discussed the Parkdoctrine before here and here.

One point from these criteria is especially worth highlighting: the FDA apparently concedes that a Park doctrine conviction is obtained “without proof that the corporate official acted with intent or even negligence.” This is unquestionably a true statement of the law. But then why is HHS attempting to use a mere Park doctrine conviction as a basis for excluding three pharmaceutical executives from participation in federal health care programs?

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FDA: Ceo´s a la carcel por promoción off-label (cont.)