390 



remain a serious menaoe as well as a niaojnificent boon to society, and 

 that their risk needed to be kept from outstripi)ino: their benefits. As 

 the reiwrt of the Humphrey subcommittee later observed, "most of the 

 educational value from the thalidomide tragedy can be credited to the 

 enterprise of American journalism." The Mintz article was singled out 

 for praise. "However, the July 15, 1962, news article set off a chain 

 reaction whicli is o;enerally credited with having contributed to ynani- 

 mous congressional approval of the Kefauver-Harris drug law." ^* 



Burdened with so much information from so many witnesses about 

 so many issues, the Congress performed remarkably in being able to 

 frame so coherent and comprehensive a piece of legislation as the Drug 

 Amendments of 1962. The emotional appeal of the thalidomide shock 

 was undeniable, and a potent motivation toward passage of drug con- 

 trol legislation; but it did not impair the quality or rationality of the 

 act that came out of the crisis. There has been abundant evidence since 

 1962 that drug control in the United States still presents many un- 

 resolved questions. But that incompleteness is attributable to the vast- 

 ness and complexity of the subject, the persistent want of authoritative 

 findings about many of its issues, and possibly the changing institu- 

 tional nature of medical practice in the I^^nited States. It cannot be said 

 that there was less than a total and dedicated eti'ort to secure all of 

 the information, from the best qualified sources, then available. And 

 as ^'resident Kennedy observed in signing it, the 1962 measure that 

 finally emerged was "very effective legislation." 



Provisions of the 1962 Drug Act for increased Federal control 



Shortly after the drug bill became law, an HEW (FDA) publica- 

 tion was issued summarizing its provisions. Its purpose was to insure 

 the reliability of prescription drags by imposing Federal controls to 

 establish their safety and efficacy; these controls dealt with research, 

 manufacturing, distribution, and use of drugs. (Paraphrase) : 



1. Adequate quality control measures were required in the manufacture of drugs 

 to assure their safety, identity, strength, quality, and purity, 



2. To be acceptable for prescribing and marketing, a new drug must meet the 

 criteria of both safety and efficacy ; it must be shown by "substantial evidence" 

 that the drug will have the effect it is represented to have — which was interpreted 

 to mean "adequate and well-controlled investigations, including clinical investiga- 

 tions, by experts qualified by scientific training and experience to evaluate the 

 effectiveness of the drug involved, on the basis of which it could fairly and re- 

 sponsibly be concluded by such experts that the drug will have the effect it 

 purports or is represented to have under the conditions for use prescribed, rec- 

 ommended, or suggested in the labeling or proposed labeling thereof." 



3. A drug already in the market might be withdrawn by FDA order, if on the 

 basis of reevaluation in the light of new evidence, it was found that there was a 

 lack of substantial evidence of its effectiveness. 



4. Approval for the marketing of a new, or an established drug, might be 

 withheld by FDA on the basis of false or misleading labeling. 



5. An established drug found unsafe might be immediately ordered off the 

 market by FDA ; this authority extended to drugs manufactured under unsatis- 

 factory conditions of quality control. 



6. FDA could also use the marketing disqualification authoritv to compel drug 

 manufacturers to maintain proper records, and to provide FDA access to the 

 records. 



7. The time allowed for FDA consideration of an application for approval of 

 a new drug was considerably loosened from the previous provision. 



8. FDA was authorized to require the recording, and reporting promptlv to 

 FDA, of any adverse effects, relative to safety and effectiveness of new drugs, or 



™ Interagency Drug Coordination. Report (1966), op. cit., p. 28. 



