391 



antibiotics already on the market. Full records of test data were to be kept by 

 manufacturers. 



9. "A firm and explicit statutory basis" was provided for the impo.sition by 

 FDA of detailed procedures for the testing of new drugs, including such matter's 

 as preclinical tests and reporting of their results, close control over the u.-^e of 

 new drugs by investigators on human subjects, certification of investigators, 

 notification (where feasible) of patients that new drugs are to be used, main- 

 tenance of records of new drug use and results. 



10. Authority to inspect drug manufacturing facilities, including all records 

 (except financial data) and the records and facilities of consulting laboratories 

 serving drug manufacturing firms on a fee basis ; the inspection authority was 

 extended to all establishments handling such drugs. 



11. Drug firms were required to register with the Department of Health. Edu- 

 cation, and Welfare annually and were to be inspected by FDA at least bi- 

 ennially. 



12. Provision was made for the establishment by the Secretary of Health. Edu- 

 cation, and Welfare of a .standard "oflicial" name of each drug, when desirable ; 

 such ofiicial names were to be used in any ofiicial drug compendium.*" 



13. All active ingredients of prescription drugs designated by brand name 

 should be indicated, as to quantity contained, in the container label, and the 

 established (i.e., ofiicial) name for the drug and each ingredient was to be 

 printed in type at least half as large as the brand names used on the label. 



14. The same requirement as in Item 13 was to be imposed on all advertise- 

 ments for prescription drugs ; in addition, an accurate indication of adverse 

 side effects, contraindications, and effectiveness of the drug should be included 

 in such advertisements. 



15. Batch certification and testing was required of antibiotic drugs, and 30 

 groups were added to the five required to be certified under previous legislation.*® 



VI. Aftermath of the Thalidomide Episode 



So many rnmifirations developed out of the public agitation trig- 

 gered by the thalidomide episode that it is not feasible to discuss them 

 all. Undoubtedly, the Kefauver-Harris bill improved the level of na- 

 tional safety relative to national control of the introduction of new 

 drugs and the use of drugs in medical care. Many constructive actions 

 were taken, or initiated, to correct the weaknesses in the system that 

 had been exposed by the near disaster. Commissioner Larrick. in- 

 deed, went so far as to say, March 24, 1964, before tlie House Com- 

 mittee on Government Operations, that the bill passed in response has 

 ''plugged all the known loopholes" in the Federal regulation of drugs. 

 However, the sampling of developments since 1962. described in this 

 section, conveys the impression that much remains to be done. The 

 progress of medical and pharmacological science has enlarged the 

 numbers and the complexities of problems a.ssociated with rendering 

 man compatible with his environment. 



Iimplementation of the Drug Amendments of 1962 



Even before the Kefauver-Harris bill became law, the FDA had 

 drafted and circulated new proposed regulations to tighten Federal 



^ The statement enlarged on this authorization, as follows : 



"With a view to the exercise of this authority, the Secretary is requirerl to review the 

 ofBcial titles of drugs in official compendiums within a reasonable time after enactment of 

 the new law and at other times as necessary to determine whether revision is necessary or 

 desirable. Before designating an official name, except when he does so upon request of an 

 official compendium, the Secretary is required to invite the appropriate compendium to 

 submit a recommendation. If the Secretary approves a name so recommended as useful, he 

 is to desigmate that name as the official name. If no recommendation is submitted, or if he 

 does not approve the name recommended, the Secretary may nevertheless designate an 

 official name which he finds to be useful. Designation of an official name by the Secretary, 

 after consultation with the appropriate official compendium, is to be by regulation promul- 

 gated after standard nonformal rulemaking procedure." (P. 7.^ 



80 Paraphrased from U.S. Department of Health, Education, and Welfare. Food and Drug 

 Administration. Summary of the Drug Amendments of 1062. (Washington, U.S. Govern- 

 ment Printing Office, November 1962, reprinted October 1963, pp. 1-8.) 



