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From Health Law Daily, December 31, 2014

Proposed rule would relax donor eligibility rules for directed and anonymous embryo use

By Harold M. Bishop, J.D.

Additional flexibility would be provided under an FDA proposal to human cells, tissues, and cellular and tissue-based products (HCT/P) establishments to make available for reproductive use embryos originally intended for reproductive use for a specific individual or couple when those embryos are subsequently used for directed or anonymous donation. Specifically, this proposed rule clarifies that if an embryo was originally intended for reproductive use for a specific individual or couple, its use for directed or anonymous donation would not be prohibited, even if the applicable donor eligibility requirements were not met (Proposed rule, 79 FR 78744, December 31, 2014).  

FDA’s rationale. The FDA is proposing these changes in response to its increased knowledge in this area and in response to comments from stakeholders regarding the importance of embryos to individuals and couples seeking access to donated embryos.

No donor eligibility exception intended. The proposed rule makes it clear that it is not creating an exception for deficiencies that occur in making the donor eligibility determination for either the oocyte donor (egg donor) or the semen donor or for deficiencies in performing donor screening or testing.

Appropriate embryo labeling to continue. The proposed rule would continue to require appropriate labeling for embryos that would describe the donor eligibility status of the individual donors whose gametes (reproductive cells) were used to form the embryo. The content of the labeling would be the same as that required under current regulations. Consistent with current labeling regulations, the FDA’s intent is to ensure that physicians have specific and accurate information to provide to recipients for use in making informed medical decisions.

Specifically, an embryo originally intended for reproductive use for a specific individual or couple that is subsequently intended for directed or anonymous donation must be prominently labeled with the following statements and symbols, as applicable:

  • “NOT EVALUATED FOR INFECTIOUS SUBSTANCES”;

  • “WARNING: Advise recipient of communicable disease risk”;

  • the BIOHAZARD legend shown in 21 C.F.R. sec. 1271.3(h);

  • “WARNING: Reactive test results for (name of disease agent or disease)”; and

  • “Advise recipient that screening and testing of the donor(s) were not performed at the time of recovery or cryopreservation of the reproductive cells or tissue, but have been performed subsequently.”

According to the FDA, these proposed labeling requirements are based on the expectation that a physician will be closely involved in the decision to use an embryo and the recognition that physicians are under legal and ethical obligations that require them to discuss the risks of communicable disease transmission stemming from the use of HCT/Ps.

Written or electronic comments on the proposed rule may be submitted through March 31, 2015.

MainStory: TopStory OrganNews FDCActNews DrugBiologicNews GMPNews LabelingNews SafetyNews

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