Hexachlorophene has a 20-year history of widespread use as a topical bacteriostatic agent, primarily against Staphylococcus aureus strains. Its property of substantivity made it uniquely desirable for this purpose, in effect a sustained release topical dosage form. Use of hexachlorophene-containing products in the nursery developed in the absence of specific safety and efficacy protocols, the phase 1, 2, and 3 studies now so familiar in drug development. Whether the Food and Drug Administration would have requested data on neurotoxicity or percutaneous absorption, had such protocols for studies on the use of 3% emulsions been submitted to the FDA, is now a moot question. The practice became well established in hospitals. Studies on newborn infants, which were possible in the 1950's and 1960's, have become progressively more complicated because of problems of patient consent.

In pointing out that the presently required safety and efficacy studies on the use of 3% hexachlorophene for bathing of newborn infants were never done, it should be added that, by the same token, no data were obtained on the relative merits of various concentrations of hexachlorophene products for this purpose. In reviewing the many clinical studies published in the past 15 years on the use of hexachlorophene-containing products in newborn nurseries, it is apparent that they were used in varying dilutions and according to varying techniques. This was less important at the time, when absorption was not known to be a consideration, than it is now.

Beginning in early 1971, several hexachlorophene absorption studies were made available to the FDA, some from industry and some in-house.

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