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The generic drug approval process has evolved over the past 30 years. In 1970 FDA established the Abbreviated New Drug Application (ANDA) as a mechanism for the review and approval of generic versions of drug products that had been approved between 1938 and 1962.[8] For drugs approved after 1962, manufacturers of generic products were required to submit complete safety and efficacy data. Until 1978 manufacturers conducted clinical efficacy and safety trials. After 1978, however, manufacturers were required to cite published reports of such trials documenting safety and efficacy. Neither of these approaches was considered satisfactory, as the former was quite expensive and the latter required evidence that was usually unavailable, i.e., data that had not been published. In 1984 the Drug Price Competition and Patent Term Restoration Act focused on modifying and accelerating the ANDA procedure and gave FDA statutory authority to approve generic versions of innovator products approved after 1962 as safe and effective.[8-10]

Unlike the New Drug Application (NDA) process, by which new chemical entities are approved for marketing, the ANDA process as revised in 1984 does not require manufacturers to include preclinical or clinical data establishing the active ingredient’s safety and efficacy[8] because these data were previously documented during the approval process for the innovator product. Because the generic product must be pharmaceutically equivalent and bioequivalent to the innovator product, it is expected that the two products will also be therapeutically equivalent. In other words, the assumption is that if the active ingredient has been shown to be safe and effective after it is absorbed into the bloodstream, any product that gives rise to the same concentrations of active ingredient in the body to the same rate and extent will produce the same effect; therefore, preclinical and clinical studies of the generic product are usually deemed unnecessary. FDA classifies products as therapeutically equivalent if they:

• Have been shown to be safe and effective.
• Are bioequivalent in that there is no known or potential bioequivalence problem and the products meet acceptable in vitro standards or, if the products do present a potential or demonstrated bioequivalence problem, they meet appropriate bioequivalence requirements.
• Have similar potential for safety and efficacy.
• Are appropriately labeled.
• Are manufactured in compliance with Current Good Manufacturing Practice guidelines

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