401 



the emphasis of a regulatory bill, based on extensive hearings on prices 

 and monopoly aspects of the drug industry, away from economics and 

 in the direction of regulation of drug products for safety and efficacy. 

 The change gratified the President whose primary concern was with 

 health and safety. This changed emphasis was consistent, moreover, 

 with much of the testimony given to the various congressional com- 

 mittees considering the legislation, by both medical witnesses and some 

 spokesmen for the drug industry itself. Even in the investigative hear- 

 ings conducted by Senator Kefauver, the medical people sought to 

 draw attention to the existing imperfections in arrangements by which 

 drugs were tested, introduced into use, and monitored thereafter. 

 Witnesses also urged the strengthening of the FDA itself, as to — 

 Manpower requirements to implement the regidations for which 

 it had long been responsible ; 



Enlarged manpower requirements to extend its functions and 

 take up its new responsibilities in the interest of public health and 

 safety ; 



Quality of professional people in upper level positions ; 

 Abilit}' to conduct scientific research to sustain and enhance its 

 professional excellence ; and 



Management of the vast and complex task of scientific informa- 

 tion exchange, with respect to drug literature and test data. 

 In dealing with such a large, complex, and changing problem as 

 prescription drugs, the Congress could not reasonably have been 

 expected to resolve all issues completely and permanently in a single 

 act. The question does not seem to have been raised, however, as to 

 whether the importance and technical difficulty of the field warranted 

 the establislnnent of a separate and continuing committee or sub- 

 committee to maintain surveillance over it. The subsequent activity of 

 Senator Plumphrey, himself a former pharmacist, as chairman of a 

 Government Operations Subcommittee concerned with interagency 

 drag coordination, met the immediate need to some extent. However, 

 one of the recommendations of Senator Humphrey's subcommittee 

 was for a congressional review of results under the 1962 amendments. 

 Specifically, the report recommended : 



Consider in the 89tli Ck>ngres9 a review of results under the Drug Amendments 

 of 1962. This might include not only analysis of experience under existing 

 statutory authority, but the soundness of FDA's administrative implementation 

 and the merit of pending proposals by Government, the professional community, 

 and industry. As a first step, FDA should make a report to the appropriate 

 committees of the Congress sometime soon after October 196^. At that time. 

 Public Law 87-781 will have been on the statute books for 3 years. Such a 

 report should be received in ample time for consideration by the executive and 

 legislative branches of FDA's program and budget for the 1967 fiscal year."' 



Undoubtedly, the thalidomide episode was ultimately beneficial to 

 many aspects of drug management in the United States. It motivated — 

 or helped to motivate — enactment of overdue Federal control legisla- 

 tion in which all (physicians, industry, and the public) seemed to have 

 been in agreement ; this agreement was reflected in the unanimous vote 

 in both houses on final passage of the legislation. The episode stimulated 

 a continuing inquiry by the Congress, and consequent further pres- 

 sure on the administration, to seek further reforms in drug manage- 

 ment. Government functions were enlarged in scientific research into 



118 "Interagency Drug Coordination," Report • • • (1966), op. cit., p. 4. 

 99-044—69 27 



