FDA withholds xeno data

The Campaign for Responsible Transplantation (CRT; New York) filed a lawsuit late in November against the FDA claiming officials are withholding information on xenotransplantation research. Following Freedom of Information Act requests that began last March, CRT director Alix Fano has been leading the campaign against the FDA to divulge documents. FDA officials note that federal law prohibits the agency from releasing such information, but Fano says that because some sponsors of xenotransplant clinical trials are selectively releasing information through the press and public presentations, FDA is in effect waiving rights to confidentiality, particularly in cases involving adverse events.

Federal guidelines for xenotransplantation research describe the development of a pilot national database, with the possibility of establishing a comprehensive system for collecting such information. In addition, a new advisory committee on xenotransplantation is expected to provide an additional public forum for considering such research (Nat. Biotechnol. 18, 699).

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Fox, J. FDA withholds xeno data. Nat Biotechnol 19, 6 (2001). https://doi.org/10.1038/83548

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