Competitive problems in the drug industry

DRUG INDUSTRY

HEARINGS

BEFORE THE

SUBCOMMITTEE ON MONOPOLY

OF THE

SELECT COMMITTEE ON SMALL BUSINESS
UNITED STATES SENATE

NINETY-FOURTH CONGRESS

FIRST SESSION

PRESENT STATUS OF COMPETITION IN THE
PHARMACEUTICAL INDUSTRY

PART 29

68-373

NOVEMBER 10 AND 11, 1975

GOVERNMENT PROCUREMENT (VOL. 8)
(BIOEQUIVALENCE AND BIOAVAILABILITY)

Printed for the use of the Select Committee on Small Business

U.S. GOVERNMENT PRINTING OFFICE
WASHINGTON: 1976

For sale by the Superintendent of Documents, U.S. Government Printing Office
Washington, D.C. 20402 - Price $2.05

CONTENTS

Page

Testimony of—

Krigstein, David J., Speaker of the House of Delegates and a Trustee

of the American Pharmaceutical Association, accompanied by Dr.

Edward G. Feldmann, Associate Executive Director for Scientific

Affairs, American Pharmaceutical Association; and Carl Roberts,

Associate General Counsel, American Pharmaceutical Association___ 13721

Ramsay, Rex C., Jr., M.D., Director, Arkansas Department of Health__ 13739

Schmidt, Dr. Alexander M., Commissioner, Food and Drug Adminis-

tration, Public Health Service, Department of Health, Education,

and Welfare, accompanied by Dr. J. Richard Crout, Director, Bu-

reau of Drugs; Dr. Bernard E. Cabana, Director, Division of Bio-

pharmaceuticals, Bureau of Drugs; Richard Merrill, Chief Counsel;

and Robert C. Wetherell, Jr., Director, Office of Legislative Services- 13747

Wojta, Gerald C, .President, Phillips Roxane Laboratories, Inc., ac-
companied by Ralph W. Stultz, Staff Counsel and Assistant Secre-
tary of North American Philips; and Dr. William Olson and Donald
Chmielewski, Philips Roxane Laboratories___

EXHIBITS

13732

Letter dated October 16, 1975, to the American Pharmaceutical Associa-
tion, Washington, D.C., from Prof. Dr. K. H. Fromming, Pharma-
zeutisches Institut, der Frein Universitat Berlin_-_-
Letter dated October 24, 1975, to Prof. Dr. K. H. Fromming, Pharma-
zeutisches Institut, der Frein Universitat Berlin, from Edward G. Feld-
man, Ph. D., Associate Executive Director for Scientific Affairs, Ameri-
can Pharmaceutical Association____.

APPENDIX

Prepared statements:

Krigstein, David J., Speaker of the House of Delegates and a Trustee

of the American Pharmaceutical Association____.

13730

13765

13774

Press release dated November 10, 1975, "Foot-Dragging by FDA

Hampers Confidence in Drug Supply," American Pharmaceutical

Association

Ramsay, Rex C., Jr., M.D., Director, Arkansas Department of Health__ 13775

Schmidt, Dr. Alexander M., Commissioner, Food and Drug Adminis-