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FDA publishes "guidance document" for transplant industry to follow in xenotransplantation research.

The US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) has published a "guidance document" for the transplant industry on nonhuman primate xenotransplantation concerning: (1) the potential public health risks posed by nonhuman primate xenografts; (2) the need for further scientific research and evaluation of the risks, particularly infectious agents; and (3) the need for public discussion concerning the issues.

In the document, the FDA points out the dilemma facing transplantation due to the shortage of human organs. "Xenotransplantation raised a major public health dilemma: how to balance the potential promise of this emerging technology to alleviate the shortage of live cells, tissues, and organs currently available for transplantation with the risk of potential transmission of infectious agents to the patient, his/her close contacts, and the public at large. Experience with human-to-human transplantation has demonstrated the transmissibility of infectious agents from donor to recipient through transplants (e.g., Human Immunodeficiency Virus (HIV), Creutzfeldt-Jacob Disease, Hepatitis B Virus and Hepatitis C Virus.)" Despite that sobering overview of the potential risks involved, the FDA feels that scientific research into xenotransplantation in humans should continue providing appropriate precautions are followed. Here are the recommendations published by the FDA in April. The agency is asking for public comments on the recommendations before it proceeds with a revised document to be issued sometime in the future.

". . . the FDA has concluded that:

(1) the use of nonhuman primate xenografts in humans raises substantial public health safety concerns within the scientific community and among the general public; (2) current scientific data indicates that human subjects, including individual xenotransplant recipients, their close contacts, and the public at large, would be exposed to significant infectious disease risk by the use of nonhuman primate xenografts; and that (3) further scientific research and evaluation is needed in order to obtain sufficient information to adequately assess and potentially to reduce the risks posed by nonhuman primate xenotransplantation.

In light of these considerations, the FDA has determined the following concerning the use of nonhuman primate xenografts in FDA-regulated products intended for human use:

(1) an appropriate federal xenotransplantation advisory committee, such as a Secretary's Advisory Committee on Xenotransplantation (SACX) currently under development within the DHHS (Department of Health and Human Services), should address novel protocols and issues raised by the use of nonhuman primate xenografts, conduct discussions, including public discussions as appropriate, and make recommendations on the questions of whether and under what conditions the use of nonhuman primate xenografts would be appropriate in the United States.

(2) clinical protocols proposing the use of nonhuman xenografts should not be submitted to the FDA until sufficient scientific information exists addressing the risks posed by nonhuman primate xenotransplants. Consistent with FDA Investigational New Drug (IND) regulations, any protocol submission that does not adequately address these risks is subject to clinical hold (i.e. the clinical trial may not proceed) due to insufficient information to assess the risks and/or due to unreasonable risk.

(3) at the current time, FDA believes there is not sufficient information to assess the risks posed by nonhuman primate xenotransplantation. FDA believes that is will be necessary for there to be public discussion before these issues can be adequately addressed."

For questions regarding the guidelines, contact: Eda Bloom, PhD, (HFM-518), Office of Therapeutics Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. Phone: (800) 835-4709. The FDA internet address for the guidelines is:
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Publication:Transplant News
Date:Jun 30, 1999
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