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BAE v. SHALALA

No. 94-1373.

44 F.3d 489 (1995)

Kun Chae BAE, Petitioner, v. Donna E. SHALALA, Secretary of the United States Department of Health and Human Services and David Kessler, Commissioner of the United States Food and Drug Administration, Respondents.

United States Court of Appeals, Seventh Circuit.

Decided January 4, 1995.

Attorney(s) appearing for the Case

Ann C. Tighe, Cotsirilos, Stephenson, Tighe & Streicker, Steven M. Kowal (argued), Burditt & Radzius, Chicago, IL, for petitioner.

Donna Morros Weinstein, Dept. of Health and Human Services, Region V, Office of the Gen. Counsel, Chicago, IL, Douglas Letter, Dept. of Justice, Civ. Div., Appellate Section, Washington, DC, Eric M. Blumberg, Federal Drug Admin., Rockville, MD, Donna E. Shalala, Dept. of Health and Human Services, Washington, DC, Margaret Porter, Annamarie Kempic, Andrew Clark, Lawrence G. McDade (argued), Dept. of Health & Human Services, Chief Counsel, Food & Drug Div., Rockville, MD, for Donna E. Shalala.

Douglas Letter, Dept. of Justice, Civ. Div., Appellate Section, Washington, DC, Eric M. Blumberg, David Kessler, Federal Drug Admin., Rockville, MD, Margaret Porter, Annamarie Kempic, Andrew Clark, Lawrence G. McDade, Dept. of Health & Human Services, Chief Counsel, Food & Drug Div., Rockville, MD, for David Kessler.

Before COFFEY and ROVNER, Circuit Judges, and FOREMAN, District Judge.

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...

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