Abstract
The ethical drug industry in the United States has been the subject of numerous congressional investigations, much criticism by medical and economic experts, and other attacks from which a large number of reform proposals have been suggested. Nonetheless, the only significant legislation enacted in this regard is the 1962 Amendments to the Food, Drug, and Cosmetic Act, the substantive portions of which are probably more the result of the thalidomide disaster than of other criticisms of the industry. Now that these changes have been in effect for a decade, an appraisal of their effects is warranted, as is a reconsideration of other changes that may also be called for, in the light of the shortcomings and strengths in the industry's performance.
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