393 



strengthen communication to the public ; 



Encourage voluntary compliance and deter infractions ; 



Strengthen international teamwork on drugs.^* 



Eventually FDA set up a mechanism for the retroactive evaluation 

 of drugs already in use, and began a project of nomenclature standard- 

 ization, as well as tightening the arrangements for evaluating new 

 drugs for both safety and efficacy. Some degree of control was also 

 exercised over the promotion of new products by drug manufacturers. 

 However, by 1968, the achievement of a generally acceptable, safe, 

 efficient, and economical system of pharmacological service in the 

 United States was still in the future, and many of the criticisms that 

 had been voiced to the Kefnuver subcommittee in 1959 and 1960 were 

 being repeated to the Subcommittee on Monopoly of the Select Com- 

 mittee on Small Business (Nelson subcommittee).^^ 



Evaluation of cfjicacy^ safety^ and comparative inerits of drugs 



An important feature of the Kefauver-Harris amendments was the 

 requirement that FDA establish and apply criteria of both safety and 

 efficacy m certifying the acceptability of new drugs, and in reviewing 

 the acceptability (or requiring the withdrawal from the market) of 

 drugs already established and in use. 



With respect to new drugs, FDA regulations have been described by 

 an FDA official thus : 



Require the person who sponsors shipment of a new drug for clinical trial to 

 report to the Food and Drug Administration, before the testing starts, the facts 

 that satisfy him that it is proper to conduct the proposed test. 



The report should include, among other things, evidence that adequate animal 

 tests have been made to show the probable effects of the drug and the ill effects 

 that should be watched for by the investigator ; evidence of adequate chemistry 

 and manufacturing control to assure a product of uniform and desirable compo- 

 sition ; a showing that the clinical investigator has good information about the 

 earlier tests so that he can make his decisions as to the desirability of administer- 

 ing the product to man, and the conditions of administration, on a soimd scientific 

 ba.sis. The report should furnish assurance that the individuals selected as in- 

 vestigators are in fact qualified to investigate the safety or effectiveness of the 

 drug, or both depending upon the nature of the experiment. There are certain 

 recordkeeping requirements as there has always been a need for records in con- 

 nection with .sound scientific work. And especially important, the report must 

 show that there is a sound plan for the investigation to be conducted.'**' 



Among actions that FDA sought to halt were cases of gross failure 

 to adhere to accepted principles of medical ethics * * * in which there 

 was essentially no preliminary animal testing" or an inadequate plan 

 of investigation, or "a situation in which it appeared that a drug was 

 in fact being marketed commercially under the guise of clinical 

 testing.'' 



Clearly (said the same speaker), measures designed to require adequate pre- 

 clinical investigations, a sound plan for investigation and the use of properly 

 trained clinical investigators by drug firms are calculated to upgrade the level 



M Interagency Drug Coordination. Report • * *. (1966), op. clt., pp. 3-S. 



85 U.S. Congress. Senate. Select Committee on Small Bu.siness. Competitive Problems in 

 the Drug Industry. Hearings before the Subcommittee on Monopoly of the * * * on 

 Present Status of" Competition in the Pharmaceutical Industry. Six parts : pt. 1, May 

 15, 16, 17, June 7, and 8. 1967 : pt. 2. June 27, 28, 29, July 24, and Aug. 8, 10, 1967 ; 

 pt. 3. Sept. 13. 14, 29 and Oct. 13, 1967 ; pt. 4. Oct. 31. Nov. 9, 15. and 2S, 1967 : pt. 5. 

 Dec. 14, 19. 1967, Jan. 18, 19, and 25, 1968: and pt. 6, Nov. 29, 1967; Feb. 6, S, 27. and 

 29. 1968. 90th Cong. 1st and 2d sess. (Washington, U.S. Government Printing Office, 

 1967 and 1968), 2752 pp. 



^ Winton B. Rankin. Assistant Commissioner of FDA. "Recent Legislation and the 

 Development of New Drugs." Third Interscience Conference on Antimicrobial Agents and 

 Chemotherapv, American Society for Microbiology. Washington, D.C. Oct. 28, 1963. Re- 

 produced in Congressional Record. (Oct. 31, 1963), p. A6S00. 



