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The U.S. Kefauver Harris Amendment or "Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act. It introduced a requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval,〔Peltzman, Sam. ( An Evaluation of Consumer Protection Legislation: The 1962 Drug Amendments ). The Journal of Political Economy, Vol. 81, No. 5. (Sep. - Oct., 1973), pp. 1051.〕〔(【引用サイトリンク】title=Promoting Safe and Effective Drugs for 100 Years )〕 required drug advertising to disclose accurate information about side effects, and stopped cheap generic drugs being marketed as expensive drugs under new trade names as new "breakthrough" medications. ==Background== The amendment was a response to the Thalidomide tragedy, in which thousands of children were born with birth defects as a result of their mothers taking thalidomide for morning sickness during pregnancy. The bill by U.S. Senator Estes Kefauver, of Tennessee, and U.S. Representative Oren Harris, of Arkansas, required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval. It should be noted that Thalidomide had not been approved for use in the United States and that the tragic birth defects that occurred were in other countries. Frances Oldham Kelsey was the FDA reviewer who refused to approve Thalidomide for use. It introduced a "proof-of-efficacy" requirement, that was not present before.〔 In addition, the Amendment required drug advertising to disclose accurate information about side effects and efficacy of treatments. Finally, cheap generic drugs could no longer be marketed as expensive drugs under new trade names as new "breakthrough" medications, as they were prior to the amendment. The law was signed by President John F. Kennedy on October 10, 1962. 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Kefauver Harris Amendment」の詳細全文を読む スポンサード リンク
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