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FDA PROPOSALS TO EASE RESTRICTIONS ON
THE USE AND SALE OF EXPERIMENTAL DRUGS

NOVI 1307

HEARING

BEFORE A

SUBCOMMITTEE OF THE

COMMITTEE ON
GOVERNMENT OPERATIONS
HOUSE OF REPRESENTATIVES

ONE HUNDREDTH CONGRESS

FIRST SESSION

APRIL 29, 1987

Printed for the use of the Committee on Government Operations

75-752

U.S. GOVERNMENT PRINTING OFFICE

WASHINGTON : 1987
For sale by the Superintendent of Documents, Congressional Sales Office

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

COMMITTEE ON GOVERNMENT OPERATIONS

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

FRANK HORTON, New York CARDISS COLLINS, Mlinois

ROBERT S. WALKER, Pennsylvania GLENN ENGLISH, Oklahoma

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

AL MOCANDLESS, 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, Ilinois
EDOLPHUS TOWNS, New York

JON L. KYL, Arizona
JOHN M. SPRATT, JR., South Carolina ERNEST L. KONNYU, California
JOE KOLTER, Pennsylvania

JAMES M. INHOFE, Oklahoma
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

WILLIAM M. JONES, General Counsel
STEPHEN M. DANIELS, 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

ERNEST L. KONNYU, California HENRY A. WAXMAN, California

JAMES M. INHOFE, Oklahoma BARNEY FRANK, Massachusetts

Ex OFFICIO
JACK BROOKS, Texas

FRANK HORTON, New York
JAMES R. GOTTLIEB, Staff Director

DANIEL W. SIGELMAN, Counsel
GWENDOLYN S. MCFADDEN, Secretary
MARY KAZMERZAK, Minority Professional Staff

(II)

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Page

Hearing held on April 29, 1987

1

Statement of:

Brook, Dr. Itzhak, professor of pediatrics and surgery, Uniformed Serv-

ices University of the Health Sciences, and chairman, FDA's Anti-

Infective Drugs Advisory Committee.....

60

Cooper, Richard M., Esq., Chief Counsel, 1977–79, Food and Drug Admin-

istration.

4

Hirsch, Dr. Martin S., infectious disease unit, Department of Medicine,

Massachusetts General Hospital and Harvard Medical School, and

chairman, Steering Committee, AIDS Treatment Evaluation Program.... 55

Moertel, Dr. Charles G., Purvis and Roberta Tabor Professor of Oncology,

Mayo Clinic and Mayo Medical School, and chairman, North Central

Cancer Treatment Group...

36

Raub, Dr. William F., Deputy Director, National Institutes of Health,

accompanied by Dr. William Friedewald, Associate Director for Disease
Prevention, Office of the Director; Dr. Maureen W. Myers, Chief, AIDS
Treatment Branch, National Institute for Allergy_and Infectious Dis-
eases; and Dr. Charles R. McCarthy, Office for Protection from Re-
search Risks, Office of the Director

16
Robinson, Marty, member, Lavender Hill Mob, Lesbian and Gay Libera-
tion Movement, accompanied by Michael Petrelis

131
Weiss, Hon. Ted., a Representative in Congress from the State of New

York, and chairman, Human Resources and Intergovernmental Rela-
tions Subcommittee: Opening statement .....

1

Young, Dr. Frank E., Commissioner, Food and Drug Administration,

accompanied by Dr. Paul D. Parkman, Acting Director, Center for

Drugs and Biologics; Dr. Donald B. Burlington, Acting Director, Divi-

sion of Biological Investigational New Drugs, Center for Drugs and

Biologics; Thomas Scarlett, General Counsel, Food and Drug Division;

Joseph A. Levitt, Executive Assistant to the Commissioner; and John

A. Norris, Deputy Commissioner ......

66

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

Cooper, Richard M., Esq., Chief Counsel, 1977–79, Food and Drug Admin-

istration: Prepared statement .....

7-11

Hirsch, Dr. Martin S., infectious disease unit, Department of Medicine,

Massachusetts General Hospital and Harvard Medical School, and

chairman, Steering Committee, AIDS Treatment Evaluation Program:

Prepared statement....

57-59

Moertel, Dr. Charles G., Purvis and Roberta Tabor Professor of Oncology,

Mayo Clinic and Mayo Medical School, and chairman, North Central
Cancer Treatment Group: Prepared statement.

41-54
Myers, Dr. Maureen W., Chief, AIDS Treatment Branch, National Insti-

tute for Allergy and Infectious Diseases: Information concerning

proposed regulations prior to their being announced on March 10........... 18
Raub, Dr. William F., Deputy Director, National Institutes of Health:

Information concerning preclearance of a certain reproposal at any
NIH's Institutes .....

20
Robinson, Marty, member, Lavender Hill Mob, Lesbian and Gay Libera-
tion Movement: Prepared statement..

132-133

Young, Dr. Frank E, Commissioner, Food and Drug Administration:

Exchange of information concerning FDA and NIH.

119

Experimental drugs data

115

Information concerning who in OMB was involved in decision to

reject Dr. Young's proposal..........

97

(III)

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