DOCUMENT RESUME ED 294 093 CG 020 759 TITLE Medical Devices and Drug Issues. Hearing before the Subcommittee on Health and the Environment of the Committee on Energy and Commerce, House of Representatives, One Hundredth Congress, First Session (April 8, 21, and May 4, 1987). INSTITUTION Congress of the U.S., Washington, DC. House Committee on Energy and Commerce. PUB DATE 87 NOTE 405p.; Serial No. 100-34. Portions contain small/marginally legible print. AVAILABLE FROMSuperintendent of Documents, Congressional Sales Office, U.S. Government Printing Office, Washington, DC 20402. PUB TYPE Legal/Legislative/Regulatory Materials (090) EDRS PRICE MF01/PC17 Plus Postage. DESCRIPTORS *Costs; *Drug Legislation; *Drug Therapy; *Drug Use; *Ethics; Hearings; Technological Advancement IDENTIFIERS Congress 100th; *Medical Devices ABSTRACT The text of three separate Congressional hearings on medical devices and drug issues is presented in this document. The first hearing considers the need for legislation to control potential abuses and illegal diversion of human growth hormone which is produced by using recombinant deoxyribonucleic acid (DNA) technology. The second hearing investigates the dramatic and continuing price increases for prescription drugs, particularly whether the reasons cited by the drug industry for these increases have any basis in fact. The third hearing is on the Federal Drug Association's implementation of the Medical Devices Amendments of 1976. Testimony from 33 witnesses, including government regulators, representatives from advocacy groups, victims and their relatives, representatives from industry, and medical experts is presented. Materials submitted for the record are included. (ABL) *****************************************************f***************** * Reproductions supplied by EDRS are the best that can be made * * from the original document. * *********************************************************************** MEDICAL DEVICES AND DRUG ISSUES HEARINGS BEFORE THE SUBCOMMITTEE ON WEALTH AND THE ENVIRONMENT OF THE COMMITTEE ON ENERGY AND COMMERCE HOUSE OF REPRESENTATIVES ONE HUNDREDTH CONGRESS FIRST SESSION APRIL 8, 21, AND MAY 4, 1987 Serial No. 100-34 Printed for the use of the Committee on Energy and Commerce U.S. GOVERNMENT PRINTING OFFICE 77-494 rs WASHINGTON : 1987 For sale by the Superintendent of Documents. Congressional Sales Office US. Government Printing Office. Washington, DC 20402 COMMITTEE ON ENERGY AND COMMERCE JOHN D. DINGELL,Michigan, Chairman JAMES H, SCHEUER, New York NORMAN Z. LENT, New York HENRY A. WAXMAN, California EDWARD R. MADIGAN, Illinois PHILIP R. SHARP, Indiana CARLOS J. MOORHEAD, California JAMES J. FLORIO, New Jersey MATTHEW J. RINALDO, New Jersey EDWARD J. MARKEY, Massachusetts WILLIAM E. DANNEMEYER, California THOMAS A. LUKEN, Ohio BOB WHITTAKER, Kansas DOUG WALGREN, Pennsylvania THOMAS J. TAUKE, Iowa AL SWIFT, Washington DON RITTER, Pennsylvania MICKEY LELAND, Texas DAN COATS, Indiana CARDISS COLLINS, Illinois THOMAS J. BLILEY, JR., Virginia MIKE SYNAR, Oklahoma JACK FIELDS, TeEBS W.J. "BILLY" TAUZIN, Louisiana MICHAEL G. OXLEY, Ohio RON WYDEN, Oregon HOWARD C. NIELSON, 1 tah RALPH M. HALL, Texas MICHAEL BILIRAKIS, Florida DENNIS E. ECKART, Ohio DAN SCHAEFER, Colorado WAYNE DOWDY, Mississippi JOE BARTON, Texas BILL RICHARDSON, New Mexico SONNY CALLAHAN, Alabama JIM eLATTERY, Kansas OF :Y SIKORSKI, Minnesota JOHN BRYANT, Texas JIM BATES, California RICK BOUCHER, Virginia JIM COOPER, Tennessee TERRY L. BRUCE, Illinois WM. MICHAEL KITZMILIXR, Staff Director THOMAS M. RYAN, Chief Counsel PAUL C. Sham, Minority Counseb:1!off Director SUBCOMMITTEE ON HEALTH AND THE ENVIRONMENT HENRY A. WAXMAN, California, Chairman JAMES H. SCHEUER, New York EDWARD R MADIGAN, Illinois DOUG WALGREN, Pennsylvania WILLIAM E DANNEMEYER, California RON WYDEN, Oregon BOB WHITTAKER, Kansas GERRY SIKORSKI, Minnesota THOMAS J. TAUKE, Iowa JIM BATES, California DAN COATS, Indiana TERRY L. BRUCE, Illinoir THOMAS J. BLILEY, JR., Virginia MICKEY LELAND, Texas JACK FIELDS, Texas CARDISS COLLINS, Illinois NORMAN F. LENT, New York RALPH M. HALL, Texas (Ex Officio) WAYNE DOWDY, Mississippi JOHN D. DINGELL, Michigan (Ex Officio) KAREN NELSON, Staff Director PETER EUDETTI, Counsel WILLIAM V. CORR, Counsel ROBERT ADLER, Counsel EDWIN H. ALLEN, Associate Minority Counsel ELLEN RIKER, Minority Staff Associate (H) CONTENTS Page Hearings held on: April 8, 198? 1 April 21, 1987 183 May 4, 1987 331 Testimony of: Benson, James S., Deputy Director, Center for Devices and Radiological Health, Food and Drug Administration, Department of Health and Human Services 384 Brown, Judity, policy specialist, American Association of Retired Persons 215 Burger, Clayton Lewis and Julia, Baltimore, MD 351 Chadwick, Sheila, Reston, VA 135 Chan, Kwai-Cheung, Group Director, Program Evaluation and Methodolo- gy Division, General Accounting Office 365 Chelinsky, Eleanor, Director, Program Evaluation and Methodology Divi- sion, General Accounting Office 365 Clark, Paul N., president, Pharmaceutical Products Division, Abbott Lab- oratories 291 Cousan, Stephen Carl, public affairs coordinator, Parent Council for Growth Normality 140 Eastman, H.C., Department of Economics, University of Toronto 321 Ferguson, Stephen L., president, CFC, Inc 361 Gordon, Benjamin, staff economist, National Council of Senior Citizens 234 Gower, James M., vice president for marketing, Genetech, Inc 119 Guildroy, Jack, member, National Legislative Council, American Associa- tion of Retired Persons 215 Hutton, William R., executive director, National Council of Senior Citi- zens 234 Jackson, James and Tama Reasoner, Washington, DC 350 Kerr, Robert B., San Gabriel, CA 18 Morrison, James C., Deputy Director, Office of Drug Standards, Depart- ment of Health and Human Services 312 Mossinghoff, Gerald J., president, Pharmaceut.cal Manufacturers Asso- ciation 261 Norris, John A., Deputy Commissioner, Food and Drug Administration, Department of Health and Human Services 312 O'Neill, Donald E., executive rice president, Warner-Lambert Co 289 Shoff, president, Winthrop Pharmaceuticals, Sterling Drug, Inc 293 Sodeman, Thomas, on behalf of College of American Pathologists 5 Springer, Jeff, Deputy General Counsel, Department of Health and Human Services 312 Taylor, Pam, Millbury, Ohio 348 Taylor, William N., student health center, Washington State University and also on behalf of American College of Sports Medicine 13 Thompson, Tam, University of Texas 3 Thompson, W. Leigh, vice president, Clinical Investigation and Regula- tory Affairs, Lilly Research, Eli Lilly & Co 123 C.' t IV Page Testimony ofContinued Todd, Terry, professor of kinesiology, University of Texas 9 Voy, Robett, United States Olympic Committee 11 Walters, Constance (video presentation) 354 Watson, Douglas G., preside.* Pharmaceuticals Division, CIBA-GEIGY Corp 284 Wolfe, Sidney, director, Pub r...: Citizen Health Research Group 356 Young, James, Sarasota, FL 388 Material submitted for the record by: American Medical Association, statem?nt 147 Ares-Serono, statement 159 Health and the Environment Subcommittee, memorandum to Members of the Subcommittee on Health a 1 the Environment 336 Kansas, University of, Medical Cen er, letters, April 14 and May 6, 1987 to Subcommittee 170 Nordisk-USA, statement 165 Sikorski, Hon. Gerry, a Representative in Congress from the State of Minnesota, statement 391 Virginia, University of, Children's Medical Center, Department of Pediat- rics, lettzrs, April 13 and May 12, 1987 to Chairman Waxman 176 6 MEDICAL DEVICES AND DRUG ISSUES Illicit Diversion and Abuse of Human Growth Hcrmone WEDNESDAY, APRIL 8, 1987 HOUSE OF REPRESENTATIVES, COMMITTEE ON ENERGY AND COMMERCE, SUBCOMMITTEE ON HEALTH AND THE ENVIRONMENT, Washington, DC. The subcommittee met, pursuant to notice, at 9:15 a.m., in room 2218, Rayburn House Office Building, Hon. Henry A. Waxman (chairman) presiding. Mr. WAXMAN. The meeting of the subcommittee will come to order. Today we will be considering the need for legislation to con- trol potential abuses and illegal diversion of human growth hor- mone. Human growth hormone, produced by using recombinant DNA technology, truly represents a modern scientific miracle. Chil- dren whose bodies do not produce sufficient growth hormone are known as pituitary dwarfes. In the past growth hormone fromca- davers greatly improved the growth-deficient child's prospects of attaining a more nearly normal adult height. Unfortunately, the supply was always limited, and in 1985 these children faceda ca- tastrophe when that natural source of the hormonewas withdrawn after being found to be contaminated with a deadly slow virus. In 1985, the Food & Drug Administration quickly approveda ge- netically engineered human growth hormone which has restored hope to the families of these children. The use of genetic engineer- ing assured these families that the history of shortages would end forever. Unfortunately, as we will hear today, it appears that the poten- tially limitless supply of human growth 1. ormone has brought with it the possibility of serious abuse. A growing number of physicians and public health specialists are concerned about the reported use oc growth hormone by athletes. There is a genuine risk that growth hormones will be soon used to treat obesity, to make tall children taller, to make normal children tall, and to slow the aging process, all without scientific evidence that the drug would be either safeor effective for such uses. Safety and effectiveness are the basic concerns