Each year, human tissue transplants allow approximately 600,000 Americans to live fuller and healthier lives. These transplants aid burn victims, the visually impaired, and persons living with cancer, heart defects, and various other illnesses and injuries. Additionally, transplanting reproductive tissue allows infertile couples to bear children. Despite these benefits, however, there are real risks associated with tissue transplantation -- risks identified in a new General Accounting Office (GAO) report as urgently requiring more effective regulation.

In response to concerns that human tissue banking was largely unregulated, and because of my concern that the Food and Drug Administration (FDA) was moving too slowly to ensure that adequate safeguards were in place for this rapidly expanding field, I asked the GAO to evaluate FDA's oversight and identify potential problems. The GAO report identifies a number of problems. Some of them are the subjects of FDA's lagging regulatory approach, but others are addressed inadequately or not at all.

In the early 1990s, there were reports of transmission of HIV by human tissues (bones) used in transplants and reports of human tissues being imported from foreign countries without documentation of testing for infectious diseases. At that time, the FDA had no rules in place to prevent such tissues from being distributed in the United States. Now it does, but they are not good enough.

FDA's current rules require that some, but not all, tissues be tested for infectious diseases. Reproductive tissue and stem cells, for example, are not covered by the current requirements. While FDA is expanding its oversight to improve tissue-banking safeguards in the growing field of tissue-based therapies and has proposed a regulatory approach broader in scope than the current regulation, it will be several years before these additional components are in place.

Also, tissue facilities are not required to register with FDA, so the agency is unable to disseminate critical information to all tissue banks or to inspect all facilities. The report also notes that misleading and false advertising by private cord blood banking facilities is not currently regulated by FDA.

If human tissue transplants are to continue to help Americans live better lives, these and the other safety matters identified in this report must be addressed quickly and completely by FDA and industry.

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