United States Fourth Circuit

A claim that the FDA has a duty to ensure the accuracy of listings in its Approved Drug Products With Therapeutic Equivalence Evaluations publication, and that the agency's refusal to do so violates the Administrative Procedure Act, was properly dismissed based on the FDA's mere ministerial role regarding those listings.

Appellate Information

• Argued 02/25/2002
• Decided 07/10/2002
• Published 07/10/2002

Judges

• Before MICHAEL, Circuit Judge, JACKSON, United States District Judge for the Eastern District of Virginia, sitting by designation, and FRIEDMAN, United States District Judge for the Eastern District of Virginia, sitting by designation.

Court

• United States Fourth Circuit

Counsel

• For Appellees:
  
• ARGUED:  James C. Burling, Hale & Dorr, L.L.P., Washington, D.C., for Appellant.  Howard Stanley Scher, Appellate Staff, Civil Division, United States Department of Justice, Washington, D.C., for Appellees.   ON BRIEF:  Mark A. Heller, Hale & Dorr, L.L.P., Washington, D.C.;  James D. Myers, Richard P. Vitek, Myers, Bigel, Sibley & Sajovec, P.A., Cary, North Carolina, for Appellant.  Robert D. McCallum, Jr., Assistant Attorney General, Douglas N. Letter, Appellate Staff, Civil Division, United States Department of Justice, Washington, D.C.;   Daniel E. Troy, Chief, Eric M. Blumberg, Deputy Chief for Litigation, Michael N. Druckman, Associate Chief for Enforcement, United States Food and Drug Administration, Rockville, Maryland, for Appellees.  Dan Hartzog, Gregory Brown, Cranfill, Sumner & Hartzog, L.L.P., Raleigh, North Carolina;  George C. Lombardi, Christine J. Siwik, James F. Hurst, Winston & Strawn, Chicago, Illinois;  Robert W. Spearman, Parker, Poe, Adams & Bernstein, L.L.P., Raleigh, North Carolina;  Edgar H. Haug, Daniel G. Brown, Frommer, Lawrence & Haug, L.L.P., New York, New York, for Intervenors.