A Trial of RSV Immune Globulin in Infants and Young Children: The FDA's View

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Abstract
We write regarding the article (Nov. 18 issue)1 reporting the results of a multicenter clinical trial that appeared to demonstrate the efficacy of immune globulin with a high titer of antibodies against respiratory syncytial virus (RSV immune globulin), given intravenously, in preventing RSV infection of the lower respiratory tract in high-risk children. The article was accompanied by a very positive editorial2. A scant two weeks later, the Blood Products Advisory Committee of the Food and Drug Administration (FDA) voted unanimously, on the basis of the same data, against recommending that this product be licensed. Although we cannot speak for the members of the advisory committee, the concern that developed at the FDA during the review of this application (which included the evaluation of protocol documents, raw data, correspondence between the FDA and the sponsor about the conduct of the ongoing trial, the results of site audits, and other materials) may interest readers of the Journal. For reasons of confidentiality, under the regulations our remarks are restricted to matters already presented for discussion at the public meeting.

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