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COMMITTEE ON GOVERNMENT OPERATIONS

.6663

19741

CHET HOLIFIELD, California, Chairman JACK BROOKS, Texas

FRANK HORTON, New York L. H. FOUNTAIN, North Carolina

JOHN N. ERLENBORN, Illinois ROBERT E. JONES, Alabama

JOHN W. WYDLER, New York JOHN E. MOSS, California

CLARENCE J. BROWN, Ohio DANTE B. FASCELL, Florida

GUY VANDER JAGT, Michigan HENRY S. REUSS, Wisconsin

GILBERT GUDE, Maryland TORBERT H. MACDONALD, Massachusetts PAUL N. McCLOSKEY, JR., California WILLIAM S. MOORHEAD, Pennsylvania JOHN H. BUCHANAN, JR., Alabama WM. J. RANDALL, Missouri

SAM STEIGER, Arizona BENJAMIN S. ROSENTHAL, New York GARRY BROWN, Michigan JIM WRIGHT, Texas

CHARLES THONE, Nebraska FERNAND J. ST GERMAIN, Rhode Island RICHARD W. MALLARY, Vermont JOHN C. CULVER, Iowa

STANFORD E. PARRIS, Virginia FLOYD V. HICKS, Washington

RALPH S. REGULA, Ohio DON FUQUA, Florida

ANDREW J. HINSHAW, California JOHN CONYERS, JR., Michigan

ALAN STEELMAN, Texas BILL ALEXANDER, Arkansas

JOEL PRITCHARD, Washington
BELLA S. ABZUG, New York

ROBERT P. HANRAHAN, Illinois
HAROLD D. DONOHUE, Massachusetts
JAMES V. STANTON, Ohio
LEO J. RYAN, California
CARDISS COLLINS, Illinois

HERBERT ROBACK, Staff Director
ELMER W. HENDERSON, General Counsel
MILES Q. ROMNEY, Counsel-Administrator

J. P. CARLSON, Minority Counsel
WARREN B. BUHLER, Minority Professional Staj

INTERGOVERNMENTAL RELATIONS SUBCOMMITTEE

L. H. FOUNTAIN, North Carolina, Chairman BENJAMIN S. ROSENTHAL, New York CLARENCE J. BROWN, Ohio JOHN C. CULVER, Iowa

GUY VANDER JAGT, Michigan DON FUQUA, Florida

JOHN H. BUCHANAN, JR., Alabama BILL ALEXANDER, Arkansas

GARRY BROWN, Michigan TORBERT H. MACDONALD, Massachusetts ALAN STEELMAN, Texas JAMES V. STANTON, Ohio

EX OFFICIO CHET HOLIFIELD, California

FRANK HORTON, New York
· DELPHIS C. GOLDBERG, Professional Staff Member

JAMES R. NAUGHTON, Counsel
GILBERT S. GOLDHAMMER, Consultant

mittee

u menit Operations. 'Intergovernmental Relations Subcom-
JSE OF ADVISORY COMMITTEES BY THE

FOOD AND DRUG ADMINISTRATION

HEARINGS

BEFORE A

SUBCOMMITTEE OF THE

COMMITTEE ON
GOVERNMENT OPERATIONS
HOUSE OF REPRESENTATIVES

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

U.S. GOVERNMENT PRINTING OFFICE

WASHINGTON : 1974

34–974 O

For sale by the Superintendent of Documents, U.S. Government Printing Office

Washington, D.C. 20402 - Price $4.65

COMMITTEE ON GOVERNMENT OPERATIONS

.6663 3

1974 a

CHET HOLIFIELD, California, Chairman JACK BROOKS, Texas

FRANK HORTON, New York L. H. FOUNTAIN, North Carolina

JOHN N. ERLENBORN, Illinois ROBERT E. JONES, Alabama

JOHN W. WYDLER, New York JOHN E. MOSS, California

CLARENCE J. BROWN, Ohio DANTE B. FASCELL, Florida

GUY VANDER JAGT, Michigan
HENRY S. REUSS, Wisconsin

GILBERT GUDE, Maryland
TORBERT H. MACDONALD, Massachusetts PAUL N. MCCLOSKEY, JR., California
WILLIAM S. MOORHEAD, Pennsylvania JOHN H. BUCHANAN, JR., Alabama
WM. J. RANDALL, Missouri

SAM STEIGER, Arizona
BENJAMIN S. ROSENTHAL, New York GARRY BROWN, Michigan
JIM WRIGHT, Texas

CHARLES THONE, Nebraska FERNAND J. ST GERMAIN, Rhode Island RICHARD W. MALLARY, Vermont JOHN C. CULVER, Iowa

STANFORD E. PARRIS, Virginia FLOYD V. HICKS, Washington

RALPH S. REGULA, Ohio DON FUQUA, Florida

ANDREW J. HINSHAW, California JOHN CONYERS, JR., Michigan

ALAN STEELMAN, Texas BILL ALEXANDER, Arkansas

JOEL PRITCHARD, Washington
BELLA S. ABZUG, New York

ROBERT P. HANRAHAN, Illinois
HAROLD D. DONOHUE, Massachusetts
JAMES V. STANTON, Ohio
LEO J. RYAN, California
CARDISS COLLINS, Illinois

HERBERT ROBACK, Staj Director
ELMER W. HENDERSON, General Counsel
MILES Q. ROMNEY, Counsel-Administrator

J. P. CARLSON, Minority Counsel
WARREN B. BUHLER, Minority Professional Staff

INTERGOVERNMENTAL RELATIONS SUBCOMMITTEE

L. H. FOUNTAIN, North Carolina, Chairman BENJAMIN S. ROSENTHAL, New York CLARENCE J. BROWN, Ohio JOHN C. CULVER, Iowa

GUY VANDER JAGT, Michigan DON FUQUA, Florida

JOHN H. BUCHANAN, JR., Alabama BILL ALEXANDER, Arkansas

GARRY BROWN, Michigan TORBERT H. MACDONALD, Massachusetts ALAN STEELMAN, Texas JAMES V. STANTON, Ohio

EX OFFICIO
CHET HOLIFIELD, California

FRANK HORTON, New York
DELPHIS C. GOLDBERG, Professional Staj Member

JAJES R. NAUGHTON, Counsel
GILBERT S. GOLDHAMMER, Consultant

CONTENTS

[earings held on-

Page

March 6..

1

March 7.

111

March 8

151

March 12.

221

March 13.

257

April 30

337

May 21.

445

tatement of

Apter, Julia, M.D., Ph. D., Rush Medical College, Chicago, III.---- 151

Cooper, Joseph D., Ph. D., professor of political science, Howard

University

192

Rodgers, William H., Jr., professor of law, Georgetown University

Law Center -

209

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 --

5, 114, 221, 257, 337, 445

Wesson, Laurence G., M.D., Jefferson Medical College, Philadelphia,

Pa..

174

etters, statements, etc.,

submitted for the record by-

Apter, Julia, M.D., Ph. D., Rush Medical College, Chicago, Ill.:

Curriculum vitae.-

151-158

Statement.

161-162

Cooper, Joseph D., Ph. D., professor of political science, Howard

University:

Curriculum vitae...

192

Statement..

192-197

Crout, J. Richard, M.D., Director, Bureau of Drugs, Food and Drug

Administration:

April 25, 1974, letter from Ayerst Laboratories regarding proposed

protocols for additional studies of propranolol hydrochloride in

rats and mice --

269-270

April 26, 1966, and May 16, 1966, the Upjohn Co. memorandums
regarding Promone injections -

330-331

August 15, 1972, excerpt from the Federal Register regarding legal

status of approved labeling for prescription drugs; prescribing

for uses unapproved by the FDÅ.

281-284

Correspondence sent to the Cardiovascular and Renal Committee
members prior to their April 13, 1973, meeting--

231-232
FDA documents filed in the Supreme Court...

414-431

FDA Public Advisory Committees as of December 31, 1973. - 440-441

FDA statement on Ob/Gyn advisory committee meeting April 27,
1973, re followup on Depo Provera users -

383-384
June 3, 1974, letter to Chairman Fountain regarding subcommittee

staff documents on propranolol and advisory committees ---- 332-334
Letters regarding carcinogenicity studies on propranolol.. 275-276
March 7, 1974, report of the Bureau of Drugs meeting with OSE
and advisory committee chairmen...

319–320

(III)

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