Antimicrobial drugs conclusions

The FDA issued numerous TFMs for active ingredients found in OTC topical antimicrobial drug products described in the 1974 proposed notice of rule making. The TFM published in 1978 describes the tentative conclusions made by the Commissioner regarding the safety and efficacy requirements for OTC topical antimicrobial drug products designed for use by healthcare professionals in hospital-type settings. 

Controversy over alteration of the microbial flora of the skin flared in the FDA Over-the-Counter (OTC) Review of Antimicrobial Drugs, especially with reference to total body exposure to antimicrobial/deodorant soaps. The relationship of routine bathing (rinsing) with these soaps with infection was implied in several studies [43-45] and shown conclusively in the study by Taplin [46] in Costa Rica in a population with a high infection rate utilizing a 2% solution of chlorhexidine in water (therefore, 2% available chlorhexidine). 

One conclusion in the proposed guidelines is that it is the sponsor s responsibility to identify comprehensively the microbiological activity of their product, to determine the appropriate microbiological end-points to be measured, and to establish the antimicrobial NOEL in an appropriate model system. These new guidelines may have a significant impact on future registration of antimicrobial animal drug products. 

The conclusions reached from these data argue that instead of continuing the search based only on the discovery of new organisms with antimicrobial activities, future searches need to be directed toward discovery of drugs specifically active against new target sites. This approach, described in more detail in Section IV, is being taken seriously today. 

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