After fits and starts, the US regulatory system seems poised to confront the range of technical, public health, and ethical issues associated with xenotransplantation research—namely testing and developing cells and organs from nonhuman sources for their potential application to human medicine. In February, members of the newly formed Secretary's Advisory Committee on Xenotransplantation (SACX) convened for the first time, giving a once-over to several sets of recently prepared guidance documents from the Food and Drug Administration (FDA; Rockville, MD) and setting a broad agenda for their next several meetings.
The direct and official beneficiary of SACX is Tommy Thompson, President Bush's Secretary of the Department of Health and Human Services (Washington DC). The Secretary considers xenotransplantation research and the committee's forthcoming advice on this subject “a priority,” says Surgeon General David Satcher, a Clinton administration appointee, who appeared before SACX members in February. The demand for human cells and organs for medical transplant procedures goes “far beyond the supply,” he reminded them. However, although xenotransplantation research represents a promising alternative source for such materials, the committee is being asked to weigh concerns over “infectious diseases, public health risks, and the social, legal, and ethical implications” of these research efforts.
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