United States Fourth Circuit

FDA did not act unlawfully in approving generic versions of a drug for an indication that was no longer protected by market exclusivity under the Orphan Drug Act, 21 U.S.C. sections 360aa-ee; the FDA is not obligated to assume bad faith on the part of generic manufacturers at the beginning of the approval process.

Appellate Information

• Argued 04/03/2002
• Decided 05/02/2002
• Published 05/02/2002

Judges

• Before WILKINSON, Chief Judge, WIDENER, Circuit Judge, and Walter K. STAPLETON, Senior Circuit Judge of the United States Court of the United States Court of Appeals for the Third Circuit, sitting by designation.

Court

• United States Fourth Circuit

Counsel

• For Appellees:
  
• ARGUED:  Mark D. Gately, Hogan & Hartson, L.L.P., Baltimore, Maryland, for Appellant.  Barbara Jeanne Stradling, Office of Consumer Litigation, United States Department of Justice, Washington, D.C., for Federal Appellees;  David G. Adams, Venable, Baetjer, Howard & Civiletti, L.L.P., Washington, D.C., for Appellee Gensia Sicor.   ON BRIEF:  Steven F. Barley, Hogan & Hartson, L.L.P., Baltimore, Maryland;  Catherine E. Stetson, Hogan & Hartson, L.L.P., Washington, D.C., for Appellant.  Robert D. McCallum, Jr., Assistant Attorney General, Larry D. Adams, Assistant United States Attorney, Office of Consumer Litigation, United States Department of Justice, Washington, D.C.;  Daniel E. Troy, Chief, Carl I. Turner, Associate Chief, United States Food and Drug Administration, Washington, D.C., for Federal Appellees.