DRUG SAFETY (Part 1) HEARINGS BEFORE A SUBCOMMITTEE OF THE COMMITTEE ON GOVERNMENT OPERATIONS EIGHTY-EIGHTH CONGRESS SECOND SESSION MARCH 24, 25, APRIL 8, AND JUNE 8, 1904 Printed for the use of the Committee on Government Operations U.S. GOVERNMENT PRINTING OFFICE COMMITTED ON GOVERNMENT OPERATIONS WILLIAM L. DAWSON, Illinois, Chairmen CHET HOLIFIELD, California L. H. FOUNTAIN, North Carolina WILLIAM 8. MOORHEAD, Pennsylvania B. WALTER RIEHLMAN, New Yask ROBERT P. GRIFFIN, Michigan GEORGE M. WALLHAUSER, New Jersey JOHN B. ANDERSON, Illinois OGDEN B. REID, New York FRANK J. HORTON, New York BILL STINSON, Washingtem CHRISTINE Ray Davis, Haff Director INTERGOVERNMENTAL RELATIONS SUBCOMMIT JOHN A. BLATNIK, Minnesota DELPHIS C. GOLDBERG, Professional Staf Member W. DONALD GRAY, Senior Investigater ༡ Apple, William S., Ph. D., executive director, American Pharmaceu tical Association; accompanied by Edward G. Feldmann, Ph. D., director, scientific division. Hussey, Hugh H., M.D., director, Division of Scientific Activities, American Medical Association; accompanied by Paul R. M. Donelan, attorney, legislative department.. Larrick, George P., Commissioner of Food and Drugs; accompanied Smith, Austin, M.D., president, Pharmaceutical Manufacturers Asso- ciation; accompanied by Theodore G. Klumpp, M.D., president, Winthrop Laboratories; Leonard A. Scheele, M.D., senior vice president, Warner-Lambert Pharmaceutical Co.; Karl H. Beyer, M.D., vice president, Merck Sharp & Dohme Research Laborato ries; Pharmaceutical Manufacturers Association; and Karl Bambach, Ph. D., senior vice president, Pharmaceutical Manufacturers Associ Letters, statements, etc., submitted for the record by- Apple, William S., Ph. D., executive director, American Pharmaceu- Excerpt from comment of Dr. Edward G. Feldman (exhibit 5).. Excerpt from President Kennedy's message to the Congress re proposed national mental health program, February 5, 1963. Exhibit 1-Prescribing information, thorazine, brand of chlor- 266 Exhibit 2-Press release from U.S. Public Health Service re drugs for the treatment of schizophrenia, March 6, 1964.. Donelan, Paul R. M., attorney Legislative Department, American Dwyer, Hon. Florence P., & Representative in Congress from the State of New Jersey: Excerpt from statement of William S. Apple, Fountain, Hon. L. H., a Representative in Congress from the State 241 Excerpt from statement of Austin Smith, M.D.. Excerpt from statement of Hugh H. Hussey, M.D. Excerpt from statement of Dr. Edward G. Feldmann. Goldberg, Dr. Delphis C., professional staff member, Intergovern- CONTENTS Letters, statements, etc.-Continued Hussey, Hugh H., M.D., director, Division of Scientific Activities, Evaluation of new drugs by the Council on Drugs: 2. Enovid (Norethynodrel with Mestranol). 3. Chloramphenicol (Chloromycetin), Excerpt from a FDA ad hoc committee report re use of Enovid.. Larrick, George P., Commissioner of Food and Drugs, U.S. Depart- ment of Health, Education, and Welfare: Advisory Committee on Investigational Drugs.. Agreements between the Public Health Service and the Food and Memorandum of understanding, FDA-NIH, May 1, 1963. Memorandum of understanding, FDA-PHS, June 1, 1963.. Memorandum of understanding, FDA-PHS, July 5, 1963. Biographical data of Joseph Francis Sadusk, Jr., A.B., M.D.. Brochure describing project RAPID, September 1963. 165 196 Food and Drug Administration requirements for additional 215 Press release announcing appointment of Joseph Francis Sadusk, Jr., A.B., M.D., as Director of the Bureau of Medicine of the Food and Drug Administration..... Regulations for the enforcement of the Federal Food, Drug, and Changes in drug labeling requirement; changes in new Changes in drug labeling requirement; changes in new Press release, January 11, 1961.. 99, 100 135 134 |