502 



the impact of the drug on German infants, during testimony on drug 

 reform bills before the House Judiciary Committee. However, Dr. 

 Taussig's appearance attracted no publicity at the time. Subsequently, 

 the thalidomide story was influential while the bills were awaiting 

 floor action in both Houses. 



Decision. — Passage of Drug Amendments of 1962. 



Decision locus. — This was a process involving successive stages of 

 negotiation : For the inclusion of drugs in the study of administered 

 prices; between the industry and Senator Kefauver as to the sub- 

 stance of the proposed legislation; between the administration and 

 Senator Kefauver as to the relative emphasis on economics and safety ; 

 within the Senate and the House as to the extent of regulation toward 

 both sets of objectives; and, finally, in conference on adjustment of 

 differences between Senate and House versions. (After the thalido- 

 mide story gained national prommence there appeared to be general 

 agreement that some sort of legislation should be adopted.) 



Assessment. — Despite the enormous volume of testimony on drug 

 legislation, 1959-62, and on management of Government controls and 

 drug information, 1962-64, it is evident that many issues remain un- 

 resolved. Although much committee staff work was done in anticipa- 

 tion of the initial investigation, the shift in emphasis from economic 

 control to medical safety made it largely irrelevant. The qualifications 

 of the staff in economic analysis were excellent but the issue was medi- 

 cal. The medical safety question was not well structured, and the 

 aspects of it that were amenable to legislative reform or suitable for 

 congressional investigation were not defined. 



Commentary. — The highly technical and complicated nature of drfug 

 regulation suggests that there are three prerequisites to effective con- 

 gressional action in this field: (1) a competent professional staff with 

 specialized knowledge of pharmacology to identify the questions to be 

 examined and analyze the evidence turned up, (2) a continuing com- 

 mittee specially devoted to the subject and gradually building a solid 

 expertise in it,' (3) the periodic use of panels of professional pharma- 

 cological advisers representing a range of different interests and views 

 to react with each other in the presence of the committee. It is also 

 apparent that there needs to be a careful division of labor between 

 ]\Iembers of Congress engaged in formulating policy in this field and 

 members of the medical profession, whether in Government or not, 

 who are engaged in the endless task of improving the technology of 

 medical practice, development of medication, information evaluation, 

 and other specialized functions. 



CASE THIRTEEN : FEDERAT^ PESTICIDE CONTROL, 19 4 7 



Background. — Scientific farming in the United States reqlnred crop 

 specialization, a favorable environment for the multiplication of pests. 

 Legislation in 1910 had provided Federal standards of effectiveness of 

 commercial poisons for farm use. Developments of synthetic organic 

 chemistry, by 1946, had produced many new pesticides of miprece- 

 dented effectiveness and low cost. These were highly beneficial in con- 

 trolling agricultural pests and carriers of epidemic diseases. They 

 replaced dangerous arsenical compounds previously used. But the 

 simple quality control arrangements previously judged adequate for a 



