USE OF ADVISORY COMMITTEES BY THE FOOD AND DRUG ADMINISTRATION HEARINGS BEFORE A SUBCOMMITTEE OF THE COMMITTEE ON GOVERNMENT OPERATIONS NINETY-THIRD CONGRESS SECOND SESSION MARCH 6, 7, 8, 12, 13; APRIL 30; AND MAY 21, 1974 Printed for the use of the Committee on Government Operations 34-974 O U.S. GOVERNMENT PRINTING OFFICE WASHINGTON: 1974 For sale by the Superintendent of Documents, U.S. Government Printing Office COMMITTEE ON GOVERNMENT OPERATIONS JACK BROOKS, Texas CHET HOLIFIELD, California, Chairman L. H. FOUNTAIN, North Carolina JOHN E. MOSS, California TORBERT H. MACDONALD, Massachusetts BENJAMIN S. ROSENTHAL, New York FERNAND J. ST GERMAIN, Rhode Island FLOYD V. HICKS, Washington JOHN CONYERS, JR., Michigan HAROLD D. DONOHUE, Massachusetts FRANK HORTON, New York PAUL N. MCCLOSKEY, JR., California JOEL PRITCHARD, Washington CONTENTS Apter, Julia, M.D., Ph. D., Rush Medical College, Chicago, Ill_ Cooper, Joseph D., Ph. D., professor of political science, Howard Rodgers, William H., Jr., professor of law, Georgetown University Schmidt, Alexander M., M.D., Commissioner, Food and Drug Ad- ministration; accompanied by J. Richard Crout, M.D., Director, Bureau of Drugs; Peter Barton Hutt, Assistant General Counsel; Lloyd B. Tepper, M.D., Associate Commissioner for Science; Barrett Scoville, M.D., Acting Director of the Division of Bureau of Neuropharmacological Projects; and Robert Wetherell, Director, Office of Legislative Services- Wesson, Laurence G., M.D., Jefferson Medical College, Philadelphia, Letters, statements, etc., submitted for the record by- Apter, Julia, M.D., Ph. D., Rush Medical College, Chicago, Ill.: Crout, J. Richard, M.D., Director, Bureau of Drugs, Food and Drug April 25, 1974, letter from Ayerst Laboratories regarding proposed protocols for additional studies of propranolol hydrochloride in 330-331 April 26, 1966, and May 16, 1966, the Upjohn Co. memorandums August 15, 1972, excerpt from the Federal Register regarding legal status of approved labeling for prescription drugs; prescribing Correspondence sent to the Cardiovascular and Renal Committee 231-232 414-431 383-384 June 3, 1974, letter to Chairman Fountain regarding subcommittee Letters regarding carcinogenicity studies on propranolol.. March 7, 1974, report of the Bureau of Drugs meeting with OSE Letters, statements, etc. submitted for the record by-Continued Page 355-356 Statement by Charles Anello, Sc. D., Director, Division of Sta- Statement by Marion J. Finkel, M.D., re DES in livestock feed Statement by Victor Berliner, Ph. D., Supervisory Pharma- Fountain, Hon. L. H., a Representative in Congress from the State Accounting of costs-Advisory committee chairmen attending 410 442 376 105 April 23, 1973, letter to members, Cardiovascular and Renal April 19, 1974, FDA memorandum regarding Depo-Provera, 277-278 447-448 338-339 112-114 450-452 Article from the January 1974 issue of Family Planning Digest 496-501 87-89 356-363 Documents, medical officers' reviews of NDA No. 12-541/S-004 446-447 272-275 Excerpts of the April 14, 1972, meeting of the Cardiovascular 482-487 February 14, 1973, open and closed sessions, minutes of the 311-314 314-317 February 25, 1974, open session, eighth meeting of the FDA FDA's compliance with requirements of Advisory Committee July 9, 1974, letter to Chairman Fountain from the American 141 77-78 460-461 June 22, 1973, pharmacology review of NDA 16-762, propra- 480 267-268 Letter, dated February 28, 1974, to D. C. Goldberg, professional 191 Letters, statements, etc., submitted for the record by-Continued Letter, dated July 15, 1974, to Hon. Roy Ash, Director, OMB, Letter, dated May 8, 1973, from Ayerst Laboratories to FDA, Letters to the editor, JAMA, and drug commentary, JAMA, Page 90-93 127 258-265 288-290 March 29, 1974, excerpt from the Federal Register regarding Minutes of 7th Meeting-Panel on Review of Orthopaedic De- Notice of meetings which appeared in the Federal Register of 150 516 489-491 November 13, 1973, letter to Chairman Holifield from Under 513-514 October 3, 1972, memorandum from Dr. Crout regarding Inderal 248-249 October 10, 1973, excerpt from the Federal Register regarding medroxyprogesterone acetate injectable contraceptive__ 323-328 Position descriptions for GS-14 and GS-15 medical officers engaged in new drug review work.. Review of clinical data-NDA 12-541, Depo Provera__ 505-509 366-367 135 386-390 Tables 0006 and 0013 of the third national cancer survey. 370-373 United States Code, chapter 5, administrative procedure, title 5, section 552_ Verbatim transcript of April 13, 1973, closed meeting of Cardi- 470 296-310 Working group on use of advisory committees in drug evaluation— avoiding conflict of interests in special Government employees_245-246 Hutt, Peter Barton, Assistant General Counsel, Food and Drug Division, HEW: Court citations regarding public disclosure.... 471 413-414 HEW policies covering records of advisory committee meetings. 465-466 462 458-459 469 Stenographic services utilized by the Bureau of Drugs. Biographical note_ Statement.. 209 215-218 Schmidt, Alexander M., M.D., Commissioner, Food and Drug Administration: Copies of letters which were sent to advisory committee chairmen 101-104 Curriculums vitae of Drs. Schmidt, Crout, Tepper, and Mr. 5-10 Estimated cost of six new committees to be established by Secre- 85-86 Statement.. Submissions to additional subcommittee questions. 11-66 515-522 Curriculum vitae_ Statement... 175 178-181 |