This was a program begun by the FDA in the 1960s after the requirement that all drugs be efficacious as well as safe. The DESI program was intended to classify all pre-1962 drugs that were already on the market as either effective, uneffective, or needs further study.
Drug loss is difficult to measure, although Peltzman’s (1973) results (see also the discussion in the text) suggest that it is very extensive.
Under the Food, Drug, and Cosmetic Act of 1938, the NDA was submitted to the FDA enumerating the uses of the drug and providing evidence of its safety.
Drugs to reduce cholesterol, for example, are intended ultimately to reduce the number of heart attacks and thus to lengthen life expectancy.
All drugs added to the formulary are noted in their respective levels of the drug lists throughout this formulary.
Drugs first marketed between 1938 and 1962 were approved as safe but required no showing of effectiveness for FDA approval.
The DrugEfficacyStudyImplementation (DESI) program was established by the FDA to review the effectiveness of these pre-1962 drugs for their labeled indications, and a determination of fully effective was made for most of these products and they remain in the marketplace.
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