Bae v. Shalala

COFFEY, Circuit Judge. Petitioner Kun Chae Bae, the former president of a generic drug manufacturing company, appeals the final order of the Food and Drug Administration (""FDA"") under the Generic Drug Enforcement Act of 1992 (""GDEA""), 21 U.S.C. §§ 335a-335c, permanently debarring him from ""providing services in any capacity to a person that has an approved or pending drug product application."" The GDEA mandates permanent debarment for any individual ""convicted of a felony under federal law for conduct . . . relating to the development or approval, . . . or . . . [other] regulation of any drug product"" under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-395.1 The FDA debarred Bae because of his 1990 felony conviction for aiding and abetting interstate travel in aid of racketeering, which arose from allegations that, in 1987, Bae provided an FDA official with an ""unlawful gratuity"" in exchange for ""official acts performed and to be performed"" by the FDA official. This case presents the question of whether and under what circumstances a civil debarment penalty may constitute retroactive punishment prohibited by the Ex Post Facto Clause of the United States Constitution.2 We affirm. I. BACKGROUND