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FDA'S REGULATION OF THE NEW DRUG VERSED
United States,

HEARINGS

BEFORE A

SUBCOMMITTEE OF THE

COMMITTEE ON
GOVERNMENT OPERATIONS
HOUSE OF REPRESENTATIVES
ONE HUNDREDTH CONGRESS

SECOND SESSION

MAY 5 AND 10, 1988

Printed for the use of the Committee on Government Operations

U.S. GOVERNMENT PRINTING OFFICE

WASHINGTON : 1988

87-445

For sale by the Superintendent of Documents, Congressional Sales Office

U.S. Government Printing Office, Washington, DC 20402

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COMMITTEE ON GOVERNMENT OPERATIONS

JACK BROOKS, Texas, Chairman JOHN CONYERS, JR., Michigan

FRANK HORTON, New York CARDISS COLLINS, Illinois

ROBERT S. WALKER, Pennsylvania GLENN ENGLISH, Oklahoma

WILLIAM F. CLINGER, JR., Pennsylvania HENRY A. WAXMAN, California

AL McCANDLESS, California TED WEISS, New York

LARRY E. CRAIG, Idaho MIKE SYNAR, Oklahoma

HOWARD C. NIELSON, Utah STEPHEN L. NEAL, North Carolina

JOSEPH J. DIOGUARDI, New York DOUG BARNARD, JR., Georgia

JIM LIGHTFOOT, Iowa BARNEY FRANK, Massachusetts

BEAU BOULTER, Texas TOM LANTOS, California

DONALD E. "BUZ" LUKENS, Ohio ROBERT E. WISE, JR., West Virginia

AMORY HOUGHTON, JR., New York MAJOR R. OWENS, New York

J. DENNIS HASTERT, Illinois
EDOLPHUS TOWNS, New York

JON L. KYL, Arizona
JOHN M. SPRATT, JR., South Carolina JAMES M. INHOFE, Oklahoma
JOE KOLTER, Pennsylvania

CHRISTOPHER SHAYS, Connecticut
BEN ERDREICH, Alabama
GERALD D. KLECZKA, Wisconsin
ALBERT G. BUSTAMANTE, Texas
MATTHEW G. MARTINEZ, California
THOMAS C. SAWYER, Ohio
LOUISE M. SLAUGHTER, New York
BILL GRANT, Florida
NANCY PELOSI, California

WILLIAM M. JONES, General Counsel
DONALD W. UPSON, Minority Staff Director and Counsel

HUMAN RESOURCES AND INTERGOVERNMENTAL RELATIONS SUBCOMMITTEE

TED WEISS, New York, Chairman THOMAS C. SAWYER, Ohio

JIM LIGHTFOOT, Iowa JOHN CONYERS, JR., Michigan

JAMES M. INHOFE, Oklahoma HENRY A. WAXMAN, California

CHRISTOPHER SHAYS, Connecticut NANCY PELOSI, California

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CONTENTS

Page

Hearings held on:

May 5.

May 10.

Statement of:

Dry, Dr. Laurence R., general and vascular surgeon, and editor and

publisher, Attorney's Medical Advisory Letter, Knoxville, TN..................

Julien, Robert M., Ph.D., staff anesthesiologist, St. Vincent Hospital and

Medical Center, Portland, OR, and formerly associate professor, depart-
ments of anesthesiology and pharmacology, Oregon Health Sciences

University ...............................

Lisbon, Dr. Alan, assistant professor of anesthesia, Harvard Medical

School, and cochairman, respiratory-surgical intensive care unit, Beth

Israel Hospital, Boston, MA ....

Morrisey, Dr. Michael, Westchester Plastic Surgical Associates, Yonkers,

NY.

Peck, Carl, M.D., Director, Center for Drug Evaluation and Research,

Food and Drug Administration, accompanied by Dr. Paula Botstein,

Deputy Director, Office of Drug Evaluation I; Philip G. Walters, M.D.,

Acting Director, Division of Surgical-Dental Drug Products; David

Scally, M.D., Reviewing Medical Officer, Division of Surgical-Dental

Drug Products; Gerald A. Faich, M.D., Director, Office of Epidemiology

and Biostatistics; Janet Arrowsmith, M.D., Medical Epidemiologist,

Office of Epidemiology and Biostatistics; and Thomas Scarlett, chief

counsel/general counsel, Food and Drug Division, Office of the HHS

General Counsel........

....... 41, 85

Walta, Dr. Douglas C., Gastroenterology Clinic and Providence Hospital,

Portland, OR......
Weiss, Hon. Ted, a Representative in Congress from the State of New

York, and chairman, Human Resources and Intergovernmental Rela-

tions Subcommittee: Opening statement ........

Wolfe, Dr. Sidney M., director, Public Citizen Health Research Group,

Washington, DC...........

Letters, statements, etc., submitted for the record by:

Botstein, Dr. Paula, Deputy Director, Office of Drug Evaluation I, Center

for Drug Evaluation and Research, Food and Drug Administration:

Information concerning reporting obligations ..........
Sawyer, Hon. Thomas C., a Representative in Congress from the State of

Ohio: Opening statement .......
Peck, Carl, M.Ə., Director, Center for Drug Evaluation and Research,
Food and Drug Administration: Prepared statement.

51-66

Scally, David, M.D., Reviewing Medical Officer, Division of Surgical-

Dental Drug Products, Food and Drug Administration: Information

concerning when FDA was informed that Versed was three to four

times more potent the Valium.

104

.

.

...

...

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APPENDIXES

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