CARDISS COLLINS, Illinois KE SYNAR, Oklahoma PHEN L. NEAL, North Carolina BERT E. WISE, JR., West Virginia COLLIN C. PETERSON, Minnesota 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) 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.... 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- Lundberg, George, M.D., editor, Journal of the American Medical Asso- Articles dated May 8, 1991, and June 12, 1991, relating to promotion- 139 Weiss, Hon. Ted, a Representative in Congress from the State of New York, and chairman, Human Resources and Intergovernmental Rela- 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 Relations Subcommittee-Continued Page Article dated July 27, 1989, from the New England Journal of Medi- 190 Article describing underreporting of adverse reactions, coauthored by 223 Documents describing collagen injections to the lips 237 177 197 ....... FDA document describing problems with Dow Corning study 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 3.-Honoraria and other payments to researchers re Retin-A. Appendix 5.—Additional documents regarding Collagen Corp........ 203 217 160 167 192 230 183 213 259 263 340 367 373 |