Human Tissue Banks: FDA Taking Steps to Improve Safety, but Some Concerns Remain
HEHS-98-25
Published: Dec 05, 1997. Publicly Released: Dec 22, 1997.
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Highlights
Pursuant to a congressional request, GAO evaluated the Food and Drug Administration's (FDA) oversight of transplanted human tissue as well as potential safety problems, focusing on: (1) gaps in the current regulation; and (2) whether and how FDA plans to address them in the approach it has proposed for regulating tissue banking.
Recommendations
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| Department of Health and Human Services | The Secretary of Health and Human Services should direct FDA to take action in several areas to improve the safety and efficacy of donated human tissue and to increase FDA's ability to regulate tissue facility activities. FDA should move ahead with its plan to require tissue facilities, including reproductive and stem cell facilities, to register with FDA. |
FDA has proposed that manufacturers of human cellular and tissue-based products should register with the FDA and list their products. This proposal was published in the Federal Register on May 14, 1998 ("Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products").
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| Department of Health and Human Services | The Secretary of Health and Human Services should direct FDA to take action in several areas to improve the safety and efficacy of donated human tissue and to increase FDA's ability to regulate tissue facility activities. FDA should move ahead with its plan to require reproductive and stem cell facilities to adhere to all requirements of the current regulation. | FDA's proposal that manufacturers of human cellular and tissue-based products register with the FDA and list their products (see Federal Register, May 14, 1998) would include stem cell and reproductive facilities. FDA also plans to publish two proposed rules in the Federal Register to address donor suitability, good tissue practices, and enforcement. The first, "Suitability Determination for Donors of Human Cellular and Tissue-Based Products," was signed out of FDA on February 23, 1999. The second, a draft proposed rule describing current good tissue practice, inspection, and enforcement issues, is under review. These proposals will discuss requirements for stem cell and reproductive...
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| Department of Health and Human Services | The Secretary of Health and Human Services should direct FDA to take action in several areas to improve the safety and efficacy of donated human tissue and to increase FDA's ability to regulate tissue facility activities. FDA should move ahead with its plan to require facilities that collect and store cord blood to provide accurate oral and written communication to consumers with regard to the state of knowledge of collection, processing, and storage techniques, as well as the likelihood of requiring cord blood transplantation, and to portray the risks and benefits relative to other therapies. |
FDA plans to require that labeling and promotion for tissue products be truthful, clear, balanced, accurate, and non-misleading. FDA plans to publish a proposed rule in the Federal Register to address good tissue practices. This rule would address labeling and claims issues as well as labeling controls. The draft proposed rule is under review. Currently, FDA does not have authority to implement recommendation.
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| Food and Drug Administration | FDA should add to its oversight plans provisions that would require tissue facilities to obtain informed consent before procuring any tissues intended for transplantation from living donors. |
FDA does not believe that the timing of informed consent affects the safety of the tissue, especially in regard to procurement of umbilical cord blood. At this time, FDA does not concur with this recommendation, but may modify its position if the agency learns that the timing of informed consent affects the safety of tissue products.
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| Food and Drug Administration | FDA should add to its oversight plans provisions that would require tissue facilities to report serious error and accidents to FDA (serious to be defined in consultation with industry representatives). |
FDA plans to promulgate, through notice and comment rulemaking procedures, requirements for adverse event reporting. However, FDA feels that reporting of errors and accidents would be resource-intensive for the agency and for industry. FDA believes that budgeting constraints would not allow FDA to review and evaluate these reports. All facilities would be required to maintain records of errors and accidents, and to make such records available for FDA review during inspections.
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| Food and Drug Administration | FDA should add to its oversight plans provisions that would require disclosure of genetic tests that have been performed on donated reproductive tissues. |
The Department of Health and Human Services Secretary's Advisory Committee on Genetic Testing is actively taking Steps to evaluate this recommendation. Currently, FDA does not have authority to implement recommendation.
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| Food and Drug Administration | FDA should add to its oversight plans provisions that would require facilities that collect, store, process, distribute, or transplant human tissues to establish validated systems to track tissues to consignees and recipients. |
The Final Rule for Human Tissue Intended for Transplantation, published July 29, 1997, requires that there be documentation of the receipt and distribution of human tissue. FDA also plans to publish a proposed rule in the Federal Register to address good tissue practices. This rule would include requirements for tracking tissues from donor to recipient and from recipient to donor. Currently, FDA does not have authority to implement recommendation.
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| Food and Drug Administration | FDA should add to its oversight plans provisions that would require tissue facilities that collect, store, process, or distribute allogeneic peripheral stem cells or any cord blood stem cells to make premarket submissions if FDA determines that adequate safety and efficacy data are not available to license such products. |
FDA intends to require IND applications for unrelated allogeneic cord blood stem cells if the agency determines that adequate safety and efficacy data are not available to license such products. A notice requesting recommended standards along with supporting clinical and laboratory data for peripheral and placental/umbilical cord blood stem cell products was published in the Federal Register on January 20, 1998. However, the proposed regulations will not specifically require that the good tissue practices and donor suitability criteria developed for unrelated allogeneic cord blood be applied to family-related allogeneic cord blood collection.
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| Food and Drug Administration | FDA should add to its oversight plans provisions that would require tissue facilities to inform FDA of the types of processing techniques used on tissues and to supply information on the safety and efficacy of these techniques. | With respect to those tissue products that pose potentially higher risks (e.g., more than minimally manipulated, not homologous, etc.), FDA intends to require premarket review, which would include evaluation of the processes used in manufacturing the product. FDA has noted, however, that because of limited resources, it is necessary to make a distinction between procedures that minimally manipulate the tissue and procedures that manipulate the tissue to a greater degree. For the former procedures, FDA will require only that validation be documented and available when FDA inspects the facility. In addition, FDA is evaluating and developing strategies for the regulation of "ancillary...
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Topics
Donation of organs, tissues, etc.Health care facilitiesHealth hazardsHealth resources utilizationInfectious diseasesProduct safetyQuality assuranceReporting requirementsSafety regulationSafety standardsStem cellsTestingTissue banking industry