Preimplantation Diagnosis for Genetic Susceptibility

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     To the Editor: In his Perspective article on preimplantation diagnosis for genetic susceptibility (Aug. 10 issue),1 an English colleague, Braude, asserts that assisted reproductive technology is unregulated in the United States. There are profound differences in the medical regulatory and certification processes between the United States and the United Kingdom. The many reasons for these differences have long-standing historical precedents but include political, fiscal, and social determinants. Nevertheless, it is incorrect to call assisted reproductive technology in the United States unregulated. Federal law requires the Centers for Disease Control and Prevention to publish annual outcomes associated with assisted reproductive technology at each clinic. This form of national outcome reporting is unique to assisted reproductive technology and cardiovascular surgery. The Food and Drug Administration regulates and inspects assisted reproductive technology laboratories, as well as confirming their compliance with additional regulations from the Clinical Laboratory Improvement Amendments. In addition to state and local regulation of medical practice, professional societies such as the Society for Assisted Reproductive Technology and the American Society for Reproductive Medicine mandate facilities' compliance with professional and ethical guidelines, which include regulations from and inspections by the College of American Pathologists and the Joint Commission on Accreditation of Healthcare Organizations.

    William E. Gibbons, M.D.

    Society for Assisted Reproductive Technology

    Birmingham, AL 35216

    wgibbons@crmbr.com

    http://www.100md.com/html/DirDu/2007/01/16/34/26/56.htm