FOOD, DRUG, AND COSMETIC ACT AMENDMENTS

OF 1977

HEARINGS

BEFORE THE

SUBCOMMITTEE ON

HEALTH AND SCIENTIFIC RESEARCH

OF THE

COMMITTEE ON HUMAN RESOURCES
UNITED STATES SENATE

NINETY-FIFTH CONGRESS

FIRST SESSION

ON

S. 1831

TO AMEND THE PUBLIC HEALTH SERVICES ACT TO PROVIDE FOR
A NATIONAL CENTER FOR CLINICAL PHARMACOLOGY, TO PRO-
VIDE SUPPORT FOR THE STUDY OF CLINICAL PHARMACOLOGY
AND CLINICAL PHARMACY, AND TO PROVIDE FOR REVIEW OF
DRUG PRESCRIBING; AND TO AMEND THE FEDERAL FOOD, DRUG,
AND COSMETIC ACT, AS AMENDED, TO PROVIDE FOR THE CON-
TINUATION AND EXPANSION OF EXISTING AUTHORITY THROUGH
THE ESTABLISMENT OF AN APPROPRIATE MECHANISM TO BE
KNOWN AS THE FEDERAL FOOD, DRUG, COSMETIC, AND DEVICES
ADMINISTRATION; TO PROVIDE FOR ADDITIONAL REGULATION
OF THE PHARMACEUTICAL INDUSTRY, AND FOR OTHER

PURPOSES

AND RELATED BILLS

96-595 O

JULY 26 AND 27, 1977

Printed for the use of the Committee on Human Resources

U.S. GOVERNMENT PRINTING OFFICE

WASHINGTON: 1978

COMMITTEE ON HUMAN RESOURCES

HARRISON A. WILLIAMS, JR., New Jersey, Chairman

JENNINGS RANDOLPH, West Virginia
CLAIBORNE PELL, Rhode Island
EDWARD M. KENNEDY, Massachusetts
GAYLORD NELSON, Wisconsin
THOMAS F. EAGLETON, Missouri
ALAN CRANSTON, California

WILLIAM D. HATHAWAY, Maine

DONALD W. RIEGLE, JR., Michigan

JACOB K. JAVITS, New York

RICHARD S. SCHWEIKER, Pennsylvania
ROBERT T. STAFFORD, Vermont

ORRIN G. HATCH, Utah

JOHN H. CHAFEE, Rhode Island

S. I. HAYAKAWA, California

STEPHEN J. PARADISE, General Counsel and Staff Director
MARJORIE M. WHITTAKER, Chief Clerk

DON A. ZIMMERMAN, Minority Counsel
GREGORY FUsco, Minority Staff Director