Drug Safety: Hearings Before a Subcommittee of the Committee on Government Operations, House of Representatives, Eighty-eighth Congress, Second Session...

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U.S. Government Printing Office, 1964 - Drugs - 2377 pages
 

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Contents

Exhibit 15Status of review of INDs May 3 1965
940
Exhibit 17Supporting documents for subcommittee summary of
957
zine
989
Exhibit 1Subcommittee summary on Meclizine Cyclizine and Chlorcy
1003
Exhibit 2Findings of NIH perinatal research project with respect
1040
Exhibit 3 Letter to Hon L H Fountain from George P Larrick trans
1048
June 9 1965 drug surveillance Meclizine Cyclizine and Chlorcycli
1051
Exhibit 5 Memorandum to George P Larrick Commissioner of Food
1056
Memorandum from Arthur Ruskin M D summarizing views
1066
Exhibit 7Memorandum of telephone conversation between Dr William
1093
Exhibit 8Memorandum to the Secretary of Health Education and Wel
1107
June 10 1965 drug surveillance EsidrixK HydrodiurilKA
1115
Co concerning the mailing of warning letter on Orabilex
1138
Exhibit 2Original warning letter on Naturetin with K 113
1139
Exhibit 3 Revised warning letter on Naturetin with K 114
1145
Exhibit 1Supporting documents for subcommittee summary
1181
Statement of
1201
Memorandum from Dr Arthur Egelman to Dr Matthew
1247
Director Division of New Drugs FDA
1254
1964 entitled Patients Response to Tranycylpromine Withdrawal
1260
Letter to Dr Jonathan Cole National Institutes of Health from
1270
Exhibit 9Article from the Medical Journal of Australia dated May
1276
Exhibit 10Article from the American Journal of Psychiatry dated Feb
1294
Exhibit 11Letter from Dr Bernard Brodie Chief Laboratory of Chemical
1305
Exhibit 12Wire from Gerald Klerman M D withdrawing as witness
1316
Exhibit 13Exchange of correspondence between Dr Fritz A Freyhan
1329
Exhibit 14Memorandum of telephone conversation between W Donald
1331
Memorandum from Inspector Frank H Desmond to the director
1348
Exhibit 16Memorandum from W B Rankin Assistant Commissioner
1351
Kirk J Kenneth Assistant Commissioner for Operations Food
1355
Exhibit 18_Exchange of memoranda between the Medical Director and
1360
Summaries of side effects and deaths associated with Parnate
1375
Exhibit 20 Documents pertaining to discrepancies in the animal data
1408
Exhibit 21 Reports on interviews of employees of Hazleton Laboratories
1417
Hearings held on Pago
1437
Exhibit 1Regulations pertaining to current good manufacturing prac
1444
Exhibit 11_Request to Washington by Chicago District for citation
1617
Exhibit 12Memorandum of telephone conversation between Elmer 0
1624
Exhibit 13Memorandum by James Nakada Division of Field Opera
1642
Exhibit 14Excerpt from Federal Food Drug and Cosmetic Act relat
1656
Exhibit 15Documents pertaining to reinspection at hospital where Page
1670
ring subsequent to May 1964 inspection of Abbott Laboratories
1685
Exhibit 17 Memorandum by Dr Arthur Ruskin Deputy Director
1715
Exhibit 21Memorandum of telephone conversations on September 8
1736
Exhibit 23Memorandum of telephone conversations involving Mr Nevis
1798
Eshibit 25Statement of longdistance telephone calls from U S Food
1812
Exhibit 29Excerpts from report of inspection at Abbott Laboratories
1841
Rankin Winton B Assistant Commissioner Food and Drug Admin
1860
Hearings held on Page
1861
Exhibit 1List of INDs for DMSO submitted by sponsors other than Paga
1901
Exhibit 4Letter from Acting Chief of FDAs Investigational Drug
1907
Letters statements etc submitted for the record
1909
Exhibit 6Letter from January 22 1966 Lancet concerning teratogenic
1919
MK665 ETHYNERONE
1948
Exhibit 1Objections to proposed drug advertising regulations filed
2004
tion drug advertising
2022
Exhibit 3Prescription drug advertising casestype of action taken
2036
Exhibit 4FDA press release on seizure of Serax for false advertising
2042
Exhibit 5Ad for Measurin from the March 21 1966 issue of the Journal
2050
Exhibit 6Memorandum of conference between representatives of
2057
Exbibit Working agreement between FTC and FDA
2087
Exhibit 9Summary of drug trade ad expenditures
2102
Depressant and Stimulant Drugs
2138
Exhibit 3Correspondence between Chairman Fountain and former Com
2159
Article from the New Republic May 14 1966 concerning dan
2169
Exhibit 6Draft of a paper on the therapeutic use of highdose LSD ses
2217
Exhibit 7Psychedelic Therapy a paper by Charles Savage M D
2232
Journal for the Study of Interper
2242
Appendix 1General
2273
Appendix 2Material relating to part 2 of the hearings
2309
Appendix 4Material relating to part 4 of the hearings
2354

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Page 1269 - As used in this subsection and subsection (e), the term "substantial evidence" means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be, concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended,...
Page 1443 - ... products conform to appropriate standards of identity, strength, quality, and purity. Laboratory controls shall include...
Page 1022 - Secretary when the application was approved, shows that such drug is not shown to be safe for use under the conditions of use upon the basis of which the application was approved...
Page 1436 - A drug or device shall be deemed to be adulterated — (a) (1) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or (2) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health...
Page 1482 - ... the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice...
Page 1113 - Register, to be in the public interest in connection with the performance of duties imposed on that agency by law.
Page 1478 - Balancing relative hardships, Congress has preferred to place it upon those who have at least the opportunity of informing themselves of the existence of conditions...
Page 1477 - The prosecution to which Dotterweich was subjected is based on a now familiar type of legislation whereby penalties serve as effective means of regulation. Such legislation dispenses with the conventional requirement for criminal conduct — awareness of some wrongdoing. In the interest of the larger good it puts the burden of acting at hazard upon a person otherwise innocent but standing in responsible relation to a public danger.
Page 1436 - ... the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug are inadequate to preserve its identity, strength, quality, and purity...
Page 1654 - ... applicable to the article on which such notice was based, such guaranty or undertaking, or a verified copy thereof, shall be made a part of such presentation of views. (b) Upon request, seasonably made, by the person to whom a notice appointing a time and place for the presentation of views under section 305 of the act has been given, or by his representative, such time or place, or both such time and place, may be changed if the request states reasonable grounds therefor. Such request shall...

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