372 



experts as a recognized resource for advice on criteria, procedures, and policies 

 for the execution of the reponsibilities of the FDA.^* 



All of the NAS-NRC recommendations were promptly endorsed by 

 Secretary Flemming- except item 6 which, he said, would require 

 further study.^^ It is worthy of note that the NAS-NRC committee 

 that developed these reconmiendations was made up of eight physicians, 

 all associated with medical schools.^*' Their recommendations might 

 be read as essentially an endorsement of the medical and drug efficacy- 

 safety aspects of the Kefauver-Celler bill. 



Senate hearings on Drug Industry Antitrust Act 



The hearing before the Senate Subcommittee on Antitrust and 

 Monopoly (Kefauver) followed somewhat the same pattern as had the 

 earlier investigative hearings. They were similarly compendious, with 

 seven volumes (4,217 pages) of testimony and exhibits, 115 witnesses, 

 and 28 days of hearings extending from July 5, 1961 through February 

 7, 1962. Emphasis, again, was on the economic and antitrust aspects 

 of the drug industry while the medical witnesses generally focused 

 on the aspects of drug safety and efficacy, and the troublesome ques- 

 tion of generic names. 



One notable difference in the second set of hearings was the tone of 

 the testimony by a spokesman for the Pharmaceutical Manufacturers 

 xissociation, (PMA). In the investigative hearings, the effect was that 

 of a hostile confrontation, relative to the expressed purpose of the 

 hearings. However, in the legislative hearings, the tone was concilia- 

 tory, and it was evident that the PMA was making every effort to 

 cooperate in acliieving generally acceptable and effective compro- 

 mises. On the efficacy and generic names issues, in particular, the 

 PMA appeared to be in full accord with the purposes of the proposed 

 legislation. 



The principal witness was Eugene N. Beesley, chairman of PjMA 

 and president of Eli Lilly & Co. He commenced his testimony by stat- 

 ing the proposition that "Our industry has a primary responsibility 

 to maintain the most painstaking and exacting standards in every step 

 of scientific research, development, manufacturing, and distribution. 

 In fact, we believe that our own individual standards of excellence 

 should be higher than any that might be imposed by law." He accepted 

 the responsibility for changing any unsound practice, and for introduc- 

 ing improvements. He also urged that, "in view of the growing com- 

 plexity of medical science and health care," the responsible Govern- 

 ment agencies should be given more assistance in fulfilling their role, 

 which was : 



* * * to establish minimum production and quality standards ; to inspect 

 periodically to insure that these standards are maintained; and to deter or 

 punish any irresponsible producer who ignores such standards. 



^ Reprinted in ibid., pp. 460-i61. 



»Ibid., pp. 463-4G7. 



38 Members of the committee were : 



Dr. C. Phillip Miller, Chairman, professor of medicine, University of Chicago School of 

 Medicine. 



Dr. John H. Dingle, professor of preventive medicine, Western Reserve University School 

 of Medicine. 



Dr. Maxwell Finland, associate professor of medicine, Harvard Medical School. 



Dr. Colin M. MacLeod, professor of medicine. New York University College of Medicine. 



Dr. Karl F. Meyer, director emeritus, George Williams Hooper Foundation, University of 

 California Medical Center, San Francisco. 



Dr. John R. Paul, professor of preventive medicine. Tale Unlversit.y School of Medicine. 



Dr. Carl F. Schmidt, professor of pharmacology. University of Pennsylvania School of 

 Medicine. 



Dr. Wesley W. Spink, professor of medicine, University of Minnesota Medical School. 



