Y 4. G74/7:084/30 PROMOTION OF DRUGS AND MEDICAL DEVICES FOR UNAPPROVED USES HEARING BEFORE THE HUMAN RESOURCES AND INTERGOVERNMENTAL OF THE COMMITTEE ON GOVERNMENT OPERATIONS ONE HUNDRED SECOND CONGRESS FIRST SESSION JUNE 11, 1991 Printed for the use of the Committee on Government Operations For sale by the U.S. Government Printing Office Superintendent of Documents, Congressional Sales Office, Washington, DC 20402 ISBN 0-16-038381-1 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 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) CONTENTS Beauchamp, Richard, M.D., Texas Department of Health.... Katz, Robert, M.D., private practitioner, clinical assistant professor of dermatology, Georgetown University School of Medicine.. Kessler, David, M.D., Commissioner, Food and Drug Administration, ac- companied by Ann Witt, Acting Director, Division of Drug Marketing, Advertising and Communications, Center for Drug Evaluation and Re- search; Kenneth Feather, Branch Chief, Drug Advertising Regulation; Robert Sheridan, Director, Office of Device Evaluation, Center for De- vices and Radiological Health; Joseph Arcarese, Director, Office of Training and Assistance; Margaret Jane Porter, assistant general coun- sel, Food and Drugs Division, Office of General Counsel; and Dr. Nirmal Mishra, Division of Surgical and Rehabilitation Devices.. Solomon, Lawrence M., M.D., professor of dermatology, University of Weiss, Hon. Ted, a Representative in Congress from the State of New York, and chairman, Human Resources and Intergovernmental Rela- Katz, Robert, M.D., private practitioner, clinical assistant professor of dermatology, Georgetown University School of Medicine: Prepared statement and article from British Journal of Dermatology Kessler, David, M.D., Commissioner, Food and Drug Administration: Pre- Weiss, Hon. Ted, a Representative in Congress from the State of New York, and chairman, Human Resources and Intergovernmental Rela- Article dated August 1991, from FDA Backgrounder entitled "Colla- Letters, statements, etc., submitted for the record by-Continued Weiss, Hon. Ted, a Representative in Congress from the State of New York, and chairman, Human Resources and Intergovernmental Rela- Article dated July 27, 1989, from the New England Journal of Medi- cine entitled "Embryonic Retinoid Concentrations After Material Article describing underreporting of adverse reactions, coauthored by 223 FDA document describing problems with Dow Corning study. FDA Memorandum dated September 10, 1990, and letter dated Sep- tember 21, 1990, describing research problems.... Litigation of Celia Anderson, regarding liquid silicone injections.......... Material selected from press conference..... Memorandum dated February 9, 1983, regarding meeting with Dr. Al Memorandum dated July 26, 1984, regarding Orentreich investiga- Pamphlet from Collagen Corp. entitled "Injectable Collagen. The end Press release describing the NIH consensus conference conclusions..... Appendix 1.-Collagen Corp.'s response to invitation to testify. Appendix 2.-Additional information provided by FDA... Appendix 3.-Honoraria and other payments to researchers re Retin-A. Appendix 4.-CDC review of collagen and PM/DM.. Appendix 5.-Additional documents regarding Collagen Corp.......... 160 167 183 213 PROMOTION OF DRUGS AND MEDICAL DEVICES FOR UNAPPROVED USES TUESDAY, JUNE 11, 1991 HOUSE OF REPRESENTATIVES, HUMAN RESOURCES AND INTERGOVERNMENTAL RELATIONS SUBCOMMITTEE OF THE COMMITTEE ON GOVERNMENT OPERATIONS, Washington, DC. The subcommittee met, pursuant to notice, at 10 a.m., in room 2247, Rayburn House Office Building, Hon. Ted Weiss (chairman of the subcommittee) presiding. Present: Representatives Ted Weiss and Donald M. Payne. Also present: James R. Gottlieb, staff director; Diana M. Zuckerman, professional staff member; Ann Marie Atkins, staff assistant; Nancy Prather, clerk; and Stephen D. McMillan, minority professional staff, Committee on Government Operations. OPENING STATEMENT OF CHAIRMAN WEISS Mr. WEISS. Good morning. The Subcommittee on Human Resources and Intergovernmental Relations is now is session. First, our apologies for starting late. There are five subcommittees that are meeting at this very same time that are on my schedule alone, so it is a very busy day. The House will be in session, as well. We will try to handle the hearing as expeditiously as we possibly can. Every day, thousands of lives are unnecessarily put at risk by the improper use of drugs or medical devices that have not been approved by the Food and Drug Administration. While these risks may be acceptable if we are treating life-threatening diseases like AIDS or cancer, it is much harder to justify those risks if the potential benefits are cosmetic. At today's hearing, we will look at the promotion of drugs and devices for cosmetic purposes and precancerous skin treatments that have not been approved by the FDA. We will hear about the widespread use of these products that has resulted from illegal and improper promotion and the life-threatening diseases and disfigurement that can result. By law, the FDA is charged with protecting the public from unsafe and ineffective drugs and devices; however, a drug or device that is approved by the FDA for one use is not necessarily safe or effective for other uses. Such "off-label" uses are not regulated by the FDA, and physicians prescribe many drugs and devices for unapproved uses. (1) |