FDA PROPOSALS TO EASE RESTRICTIONS ON NOV 13 1307 HEARING BEFORE A SUBCOMMITTEE OF THE GOVERNMENT OPERATIONS HOUSE OF REPRESENTATIVES 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 For sale by the Superintendent of Documents, Congressional Sales Office KF 27 CONTENTS 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, Raub, Dr. William F., Deputy Director, National Institutes of Health, accompanied by Dr. William Friedewald, Associate Director for Disease Prevention, Office of the Director; Dr. Maureen W. Myers, Chief, AIDS Treatment Branch, National Institute for Allergy and Infectious Dis- eases; and Dr. Charles R. McCarthy, Office for Protection from Re- search Risks, Office of the Director Robinson, Marty, member, Lavender Hill Mob, Lesbian and Gay Libera- Weiss, Hon. Ted., a Representative in Congress from the State of New 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, 41-54 18 Robinson, Marty, member, Lavender Hill Mob, Lesbian and Gay Libera- 20 132-133 |