Bae v. Shalala

44 F.3d 489 (1995)

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Bae v. Shalala

United States Court of Appeals for the Seventh Circuit
44 F.3d 489 (1995)

AR

Facts

Kun Chae Bae (plaintiff) was president of a generic-drug company. Bae pleaded guilty to bribing a Food and Drug Administration (FDA) administrator who was evaluating the company’s new-drug applications. After Bae pleaded guilty, the FDA notified Bae that he would be debarred from participation in the generic-drug industry. The FDA offered Bae a hearing to contest the issue if he provided specific facts relevant to his debarment. Bae failed to do so, and the FDA issued an order permanently debarring Bae. Bae sued, arguing that the debarment was a penalty in violation of the Ex Post Facto Clause of the United States Constitution.

Rule of Law

Issue

Holding and Reasoning (Coffey, J.)

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Casebooks

Food and Drug Law

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