FDA PROPOSALS TO EASE RESTRICTIONS ON NOVI 1307 HEARING BEFORE A SUBCOMMITTEE OF THE COMMITTEE ON ONE HUNDREDTH CONGRESS FIRST SESSION APRIL 29, 1987 Printed for the use of the Committee on Government Operations 75-752 U.S. GOVERNMENT PRINTING OFFICE WASHINGTON : 1987 U.S. Government Printing Office, Washington, DC 20402 COMMITTEE ON GOVERNMENT OPERATIONS JACK BROOKS, Texas, Chairman JOHN CONYERS, JR., Michigan FRANK HORTON, New York CARDISS COLLINS, Mlinois ROBERT S. WALKER, Pennsylvania GLENN ENGLISH, Oklahoma WILLIAM F. CLINGER, JR., Pennsylvania HENRY A. WAXMAN, California AL MOCANDLESS, California TED WEISS, New York LARRY E. CRAIG, Idaho MIKE SYNAR, Oklahoma HOWARD C. NIELSON, Utah STEPHEN L. NEAL, North Carolina JOSEPH J. DIOGUARDI, New York DOUG BARNARD, JR., Georgia JIM LIGHTFOOT, Iowa BARNEY FRANK, Massachusetts BEAU BOULTER, Texas TOM LANTOS, California DONALD E. "BUZ" LUKENS, Ohio ROBERT E. WISE, JR., West Virginia AMORY HOUGHTON, JR., New York MAJOR R. OWENS, New York J. DENNIS HASTERT, Ilinois JON L. KYL, Arizona JAMES M. INHOFE, Oklahoma WILLIAM M. JONES, General Counsel HUMAN RESOURCES AND INTERGOVERNMENTAL RELATIONS SUBCOMMITTEE TED WEISS, New York, Chairman THOMAS C. SAWYER, Ohio JIM LIGHTFOOT, Iowa JOHN CONYERS, JR., Michigan ERNEST L. KONNYU, California HENRY A. WAXMAN, California JAMES M. INHOFE, Oklahoma BARNEY FRANK, Massachusetts Ex OFFICIO FRANK HORTON, New York DANIEL W. SIGELMAN, Counsel (II) Page Hearing held on April 29, 1987 Brook, Dr. Itzhak, professor of pediatrics and surgery, Uniformed Serv- ices University of the Health Sciences, and chairman, FDA's Anti- Infective Drugs Advisory Committee..... Cooper, Richard M., Esq., Chief Counsel, 1977–79, Food and Drug Admin- Hirsch, Dr. Martin S., infectious disease unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, and chairman, Steering Committee, AIDS Treatment Evaluation Program.... 55 Moertel, Dr. Charles G., Purvis and Roberta Tabor Professor of Oncology, Mayo Clinic and Mayo Medical School, and chairman, North Central Raub, Dr. William F., Deputy Director, National Institutes of Health, accompanied by Dr. William Friedewald, Associate Director for Disease 16 131 York, and chairman, Human Resources and Intergovernmental Rela- 1 Young, Dr. Frank E., Commissioner, Food and Drug Administration, accompanied by Dr. Paul D. Parkman, Acting Director, Center for Drugs and Biologics; Dr. Donald B. Burlington, Acting Director, Divi- sion of Biological Investigational New Drugs, Center for Drugs and Biologics; Thomas Scarlett, General Counsel, Food and Drug Division; Joseph A. Levitt, Executive Assistant to the Commissioner; and John A. Norris, Deputy Commissioner ...... Letters, statements, etc., submitted for the record by: Cooper, Richard M., Esq., Chief Counsel, 1977–79, Food and Drug Admin- istration: Prepared statement ..... Hirsch, Dr. Martin S., infectious disease unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, and chairman, Steering Committee, AIDS Treatment Evaluation Program: Moertel, Dr. Charles G., Purvis and Roberta Tabor Professor of Oncology, Mayo Clinic and Mayo Medical School, and chairman, North Central 41-54 tute for Allergy and Infectious Diseases: Information concerning proposed regulations prior to their being announced on March 10........... 18 Information concerning preclearance of a certain reproposal at any 20 132-133 Young, Dr. Frank E, Commissioner, Food and Drug Administration: Exchange of information concerning FDA and NIH. Information concerning who in OMB was involved in decision to |