FDA plans xenotransplant guidelines

An article in the New England Journal of Medicine caused an unexpected stir after scientists pointed out that xenotransplantation raises the possibility of spreading infections from animals to humans. The reaction was surprising, according to Philip Noguchi, director of the FDA's division of cellular and gene therapies and one of the co-authors of the article.

The article was intended as part of an ongoing public discussion, Noguchi told BioCentury. Last fall, the FDA began receiving calls from hospital institutional review boards (IRBs), wanting to know the regulations on transplantation of baboon hearts. As a result, the agency began discussing the potential for the spread of infectious diseases and now plans to publish draft guidelines for xenotransplantation before year-end. ...