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Executive Summary

EXOSURF/SURVANTA USE RESPONSIBLE FOR 8% DROP IN INFANT MORTALITY rate in the U.S. between 1989 and 1991, HHS Secretary Sullivan stated at an April 21 press conference on new data on maternal and infant health. Primarily because of the recent availability of the lung surfactants, Sullivan reported, the U.S. infant mortality rate has dropped from 9.7 deaths per 1,000 births in 1989 to 9.1 per 1,000 in 1990 and 8.9 in 1991. HHS officials cautioned that, although data on the cause of the drop is sketchy, such a large reduction coinciding with the introduction of surfactants leads them to the conclusion that the drugs were the primary factor. The officials cited statistics that show the entire infant mortality reduction is attributable to greater survival in the first 28 days of life. Burroughs Wellcome's synthetic surfactant Exosurf and Abbott's bovine-derived product Survanta treat infant respiratory distress syndrome, a major cause of deaths among newborns. In July 1991, Burroughs Wellcome estimated that 25,000 premature infants had received Exosurf one year postmarketing. About 50,000 infants develop RDS annually. Sullivan's attribution of the drop in infant mortality to the lung surfactants is indirectly high praise for FDA's Treatment IND program. Exosurf was approved in August 1990 and Survanta was approved in July 1991. However, the effects attributed to the drugs by Sullivan were produced in part when they were available under Treatment INDs. Burroughs Wellcome has said it made Exosurf available free of charge to 11,400 infants in 450 hospitals in the U.S. and Canada under the program. Abbott has said "more than 7,000" infant patients received Survanta free under its Treatment IND. Both protocols were begun in 1989. Started in 1987, the Treatment IND program arguably has been as effective in speeding the availability of new drugs as FDA's accelerated approval efforts, without the public fanfare. To date, FDA has made 26 drugs available before final approval under Treatment INDs. Three of the more recent Treatment INDs are: Warner-Lambert's anti-Alzheimer's drug Cognex (tacrine), expected to reach 15,000 patients; Adria's antibiotic for AIDS patients, Mycobutin (rifabutin); and Ortho's anti-cancer agent 2- chlorodeoxyadenosine, being studied by the National Cancer Institute for hairy cell leukemia.

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