Wited States 0469 PROBLEMS WITH FDA'S REGULATION OF THE NOISTATO IDE FEB -6 1992 HEARING BEFORE THE HUMAN RESOURCES AND INTERGOVERNMENTAL OF THE COMMITTEE ON GOVERNMENT OPERATIONS ONE HUNDRED SECOND CONGRESS FIRST SESSION APRIL 10, 1991 Printed for the use of the Committee on Government Operations 47-872 U.S. GOVERNMENT PRINTING OFFICE WASHINGTON: 1992 For sale by the U.S. Government Printing Office Superintendent of Documents, Congressional Sales Office, Washington, DC 20402 ISBN 0-16-037227-5 COMMITTEE ON GOVERNMENT OPERATIONS JOHN CONYERS, JR., Michigan, Chairman CARDISS COLLINS, Illinois TED WEISS, New York STEPHEN L. NEAL, North Carolina ROBERT E. WISE, JR., West Virginia GERALD D. KLECZKA, Wisconsin ROSA L. DELAURO, Connecticut JOHN W. COX, JR., Illinois FRANK HORTON, New York CHRISTOPHER SHAYS, Connecticut C. CHRISTOPHER COX, California ILEANA ROS-LEHTINEN, Florida WILLIAM H. ZELIFF, JR., New Hampshire SCOTT L. KLUG, Wisconsin BERNARD SANDERS, Vermont (Independent) Graboys, Thomas B., M.D., Lown Cardiovascular Group, Harvard Medical Pitt, Bertram, M.D., chief, Division of Cardiology, University of Michigan Temple, Robert J., M.D., Director, Office of Drug Evaluation, Food and Drug Administration, accompanied by Raymond J. Lipicky, M.D., Di- rector, Cardio-Renal Division; Sughok K. Chun, M.D., reviewing medi- cal officer; Kenneth R. Feather, Chief, Drug Advertising Branch; Wil- liam V. Purvis, consumer safety officer, Drug Advertising Branch; David G. Adams, associate chief counsel for drugs; and Denver Presley, former consumer safety officer.. Weiss, Hon. Ted, a Representative in Congress from the State of New Pitt, Bertram, M.D., chief, Division of Cardiology, University of Michigan 17 |