There are about 150 assisted reproductive technology programs in the United States. It is less prescriptive than traditional FDA regulation and it has generally been well received by industry. The Proposed Approach Addresses Certain Omissions in Current Regulation

We have three concerns about omissions in the current regulation that FDA has identified and plans to address under its proposed approach: (1) lack of registration of tissue facilities, (2) some types of tissue facilities not covered under the current regulation, and (3) misleading and false advertising in cord blood banking. Proposed Approach Does Not Adequately Address Certain Issues

Four issues not addressed in the current regulation are addressed in the proposed approach but in a manner that does not adequately eliminate potential safety problems: (1) the lack of error and accident reporting to FDA, (2) inadequate tracking systems, (3) the lack of safety and efficacy data on specific stem cell therapies, and (4) inadequate tissue-processing techniques. FDA officials stated that the proposed approach addresses this problem, but tissue tracking is mentioned in the proposed approach only as an example of good tissue practices and its role in the transmission of communicable diseases. Stem cells that were obtained for autologous use or from a close blood relative (related allogeneic) would not require FDA approval. More than minimally manipulated cells or tissues would be subject to processing controls and to premarket requirements to determine safety and effectiveness. For these tissues, FDA would require that the validation of the procedures be documented and available when FDA inspects a facility but would not require the submission of any information on processing. Conclusions

In its proposed approach, FDA addresses three problems we identified as not covered in the current regulation: registration of tissue banks, oversight of reproductive and stem cell facilities, and false product claims. In four instances, we found that the proposed approach addresses issues that are not covered in the current regulation but does so in a manner that is inadequate to eliminate potential safety problems. FDA should also 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; disclosure of genetic tests that have been performed on donated reproductive tissues; tissue facilities to report serious error and accidents to FDA (“serious” to be defined in consultation with industry representatives); facilities that collect, store, process, distribute, or transplant human tissues to establish validated systems to track tissues to consignees and recipients; 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; and 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. Comments From the Food and Drug Administration

The following are GAO’s comments on FDA’s October 23, 1997, letter.
Why GAO Did This Study

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.

What GAO Found

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.