Human Tissue BanksFDA Taking Steps to Improve Safety, but Some Concerns Remain Gao ID: HEHS-98-25 December 5, 1997
Each year, human tissue transplants allow 600,000 Americans to live fuller and healthier lives. These procedures aid burn victims, the visually impaired, and persons living with cancer, heart defects, and other illnesses and injuries. The Food and Drug Administration (FDA) is in the process of expanding its oversight of tissue banks to safeguard human health. FDA's regulation for tissue transplants specifies minimum medical screening and infectious disease testing and the documenting of these activities and provides for retaining, recalling, or destroying human tissue for which such documentation is unavailable. GAO found a number of safety problems that are not controlled under current regulations. Some of these concerns are being addressed by FDA, but others are not being addressed or will not be addressed adequately.
GAO noted that: (1) FDA is just now expanding its oversight to improve tissue-banking safeguards in the growing field of tissue-based therapies; (2) FDA has proposed a regulatory approach that is much broader in scope than the current regulation; (3) still in its formative stages, the regulatory approach describes a risk-based approach that industry has generally received well; (4) FDA's proposed approach would alleviate three safety problems not covered by the current regulation: (a) FDA has no universal registry of tissue facilities currently operating in the United States; (b) the current regulation does not cover reproductive tissue or stem cell facilities; and (c) there are numerous instances of misleading and false advertising in private cord blood banking; (5) two problems that FDA does not address in the current regulation or in the proposed approach are: (a) some facilities obtain informed consent after infant delivery, raising safety and ethical concerns about cord blood; and (b) FDA has no current or proposed requirements for disclosing to recipients whether genetic tests have been performed on reproductive tissues and stem cells; and (6) four instances in which FDA's proposed approach inadequately addresses potential safety problems not covered in the current regulation are: (a) facilities would be required to record and investigate errors and accidents but not to report them to FDA; (b) the proposed approach only minimally mentions tracking tissues as good tissue practices and then only in respect to controlling disease transmission; (c) FDA will not require premarket submissions when cells or tissues are to be used in the person from whom they are obtained or in a close blood relative; and (d) FDA has proposed that certain tissue products be subject to premarket approval and that it evaluate processing techniques used on those products, but, for minimally manipulated tissue products, would require only that the validation of the procedure be documented and available when FDA inspects facilities.Recommendations
Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.Director: Team: Phone: