392 



control over the testino- and introduction into use of new drufjs. The 

 action prompted some inquires as to whether further congressional 

 action was needed. However, upon passage of the act, the FDA further 

 amended and strengthened its proposed regulations, based on the 

 added authority the act conferred. The new regulations went into effect 

 in February 1963, and an FDA conference with the drug industry 

 was held February 15, 1963, to explain their purposes and terms.^^ 



Some strengthening of FDA personnel and resources also followed 

 passage of the 1962 measure. The agency was reorganized November 1, 

 1963, and during the fiscal years 1963 and 1964 it recruited 66 additional 

 physicians and 651 other scientists. A medical director was appointed. 



Significant new drug regulations [were] issued. Interagency coordination has 

 been strengthened. Progress has been made in strengthening FDA relations with 

 State regulatory authorities. A National Food and Drug Advisory Council has 

 been appointed and has held its first meeting. A Medical Advisory Board is soon 

 to be activated. Helpful discussion has been held with an important new Drug 

 Review Board of the National Academy of Sciences-National Research Council."^ 



On the other hand, the Second Citizens' Advisory Committee on the 

 Food and Drug Administration reported, October 25, 1962, a long 

 list of recommended actions to strengthen FDA, and professed itself 

 "deeply concerned" over the lack of response to earlier recommenda- 

 tions the Advisory Committee had presented. In particular, the estab- 

 lishment of a Food and Drug Institute under a scientific director was 

 considered by the Committee as an urgent requirement.^^ 



Criticism of the FDA, in 1966, in a report by the Government Opera- 

 tions Committee of the Senate, suggests that the agency had not yet 

 responded fully to its enlarged charter of responsibilities. Tlie report 

 recommended : 



Further strengthening of interagency coordination on drug issues ; 



Consider possible new Cabinet "Department of Health" ; 



Assure efficient, economical procurement of drugs by agencies ; 



Make FDA a center of excellence : 



Review periodically the implementation of the 1962 drug law ; 



Improve FDA teamwork with professional organizations ; 



Foster greater respons^iltility by private scientists and professional orga- 

 nizations : 



Strengthen Federal intramural and extramural drug research, including 

 key disciplines ; 



Assure observance of patient consent to experimentation ; 



Set up modern agency and interagency administrative information 

 systems ; 



Establish Federal network of information on the literature of science ; 



Modernize patient records in Federal hospitals ; 



Improve reporting and evaluation of adverse reactions and accidental 

 poisonings ; 



Foster specialized information centers on drugs ; 



Improve reporting and analysis of maternity and birth records ; 



Foster advances in undergraduate and postgraduate education and infor- 

 mation on drug therapy ; 



Establish nationwide, physician-to-physician telephone computer service 

 for emergency needs ; 



Strengthen Federal communication to practitioners ; 



Protect privileged information ; make available other scientific informa- 

 tion : 



"1 U.S. Department of Health, Education, and Welfare. Food and Dru? Administration. 

 Proeeedlnsrs, FDA Conference on the Kefauver-Harris Druir Amendments and Proposed 

 Regulations, Feb. 15, 1963. ( Washinfjton, U.S. Government Printing Office, 1963.) 85 pp. 



*" Interagency drug coordination. Report * * * (1966), op. clt., p. 31. 



82 This report was reproduced in part in Humphrey hearings, pt. 2, op. cit., pp. 428-447. 

 See especially pp. 440-441. 



