Establishing Oversight

Because of its therapeutic promise, xenotransplantation is likely to go forward, despite fears of the introduction of new epidemics into the human population and other concerns. The question now being raised in several quarters is whether local or federal authorities should oversee the field, and whether voluntary guidelines or more formal regulations should be invoked. Stephen Morse, an assistant professor of virology at Rockefeller University, says that the issues raised by cross-species tra

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Stephen Morse, an assistant professor of virology at Rockefeller University, says that the issues raised by cross-species transplantation are serious, but manageable. He suggests that appropriate safeguard systems can and should be put in place.

"While our first line for these [experiment] approvals is always at the institutional level, looking at these issues requires some special expertise that is not that broadly distributed," Morse comments. "My view is that the regulatory aspects should not be more burdensome than necessary, but that there should be some sort of centralized resource that provides some oversight."

According to Philip Noguchi, director of the Food and Drug Administration's division of cell and gene therapy, his agency already has jurisdiction over exnotransplantation of cells, tissues, and transgenically altered solid organs. To cover other solid organ xenografts, FDA is now considering the development of voluntary guidelines in cooperation with the Institute of Medicine (IOM), the Centers ...

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