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Xenotransplantation: regulatory challenges.

E T Bloom1

  • 1Division of Cellular and Gene Therapies (HFM-518), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, 20852, Rockville, MD, USA. bloom@cber.fda.gov

Current Opinion in Biotechnology
|June 19, 2001
PubMed
Summary

US government agencies issued key xenotransplantation policies and guidance documents in 1999-2000. Public Health Service and FDA addressed critical xenotransplantation issues through publications and meetings.

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Area of Science:

  • Biomedical Science
  • Public Health Policy
  • Regulatory Affairs

Background:

  • Xenotransplantation, the transplantation of non-human organs into humans, presents unique scientific and ethical challenges.
  • The late 1990s saw increased interest and development in xenotransplantation research.
  • A need for clear governmental oversight and guidance was recognized.

Purpose of the Study:

  • To document the US government's regulatory and policy actions concerning xenotransplantation during 1999-2000.
  • To identify key issues discussed in public forums regarding xenotransplantation.
  • To provide a historical overview of early US governmental engagement with xenotransplantation.

Main Methods:

  • Review of published policy and guidance documents from US government agencies.

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  • Analysis of records from public meetings of advisory committees.
  • Identification of the issuing bodies and dates of relevant documents.

    • Main Results:

    • The Public Health Service published one policy/guidance document.
    • The Food and Drug Administration (FDA) published two policy/guidance documents.
    • The FDA's xenotransplantation subcommittee held two public meetings to discuss specific issues.

    Conclusions:

    • The US government actively engaged in developing policy and guidance for xenotransplantation during 1999-2000.
    • Public discourse and regulatory development were concurrent in the early stages of US xenotransplantation policy.
    • These actions laid groundwork for future regulatory frameworks governing human xenotransplantation efforts.