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The legislative history leading to the codification of the 1902 Biologics Control Act into the 1944 Public Health Service Act included a proposal that biological products have ‘efficaciousness’ in addition to the safety, potency, and purity requirements already in the statute.  HoweverHowever, the proposed additional requirement of efficaciousness was not carried into the 1944 Act.  In March 1972 the Government Accounting (later called Accountability) Office (GAO) reported that DBS had not required effectiveness of biological products despite the fact that they were also ‘drugs’ under the statutory definition, and drugs had to be effective as well as safe under the 1962 Amendments to the Food, Drug, and Cosmetic Act.  In the same month NIH announced its intention to review all of its biological products and issued a call for substantial evidence of effectiveness, the standard that was applied to drugs.  During a May 1972 Congressional hearing Department of Health, Education, and Welfare (DHEW) Secretary Elliott Richardson announced that DBS should be transferred to FDA, and the following month he did just that.

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