New FDA Regulation Will Impact Donor Egg, Embryo Transfers

A big change in the third-party pregnancy world is sneaking up on the radar, and many patients who are considering or planning to use donor sperm, eggs, or embryos could be caught off-guard.

New regulations on donor screening, issued by the United States Food & Drug Administration (FDA), will go into effect on May 25 2005. The goal is to prevent disease transmission, but some experts feel the arbitrary nature of the guidelines may be unwittingly reaching beyond that goal and could wind up costing infertility patients precious time and money.

While the FDA has regulated the donation of some human tissues since 1993, the new rule will extend regulations to include screening and testing of all donors of cord blood, semen, oocytes (eggs), and embryos. In short, with exceptions made only for urgent medical necessity, all donors of human tissues will be required to pass certain tests before their tissues can be used by another party.

While the FDA's efforts at disease prevention are commendable, says Dr. Eric Surrey of the Colorado Center for Reproductive Medicine, the testing requirements make sense for most tissue cell donations, but not for the cells known as gametes -- sperm and eggs.

"The greatest impact will be seen by patients who are planning to use donor egg and embryo, and not as great for those using donor semen," says Surrey, who is also the current President of the Society of Assisted Reproductive Technologies (SART).

The crux of the problem can be boiled down to 7 crucial days -- the time period during which donors must be tested for certain communicable diseases, a partial list of which is HIV, hepatitis, Creutzfeldt-Jakob Disease, and more. The screening, which includes a review of risk factors, clinical evidence, and blood testing, must be performed within 7 days either before or after the actual donation (for example, in the case of an egg donor, the egg retrieval procedure.) While the results of the screening/testing pending, any donated tissues (example: retrieved eggs) will be quarantined and unusable until all tests are passed.

"We'd like to see that testing time period be expanded to at least 14 days," Surrey says. "The window is simply not wide enough, and could result in an increase in cancelled treatment cycles." Such starting and stopping of ART cycles wind up costing patients, since they would have invested some fees already up to the point that the cycle was cancelled. Having more time during which to screen and test donors will prevent at least some of the potential for cancelled cycles.

Surrey continues, "This narrow window of testing time allowed by the FDA could result in an increase in the potential that embryos transfers may be cancelled, with the greater possibility that embryos may have to be discarded."

Additionally, concerns are being expressed about the disposition of frozen embryos, already a hot topic in the infertility world.

"The new regulations will lead to a reduction in options for patients who have frozen embryos," Surrey warns. The reason for this is that couples who wish to donate their frozen embryos to other infertile couples would have had to engage in the newly required screening/testing. If they had not already submitted to such testing within that FDA-approved 7-day period prior to egg retrieval, the couple would be disqualified for donating any of their resulting embryos.

Virtually none of the estimated hundreds of thousands of embryos that are currently frozen would be eligible for embryo donation.

Interestingly, there's been little media attention paid to this upcoming family-building obstacle, save for a recently issues press release (http://www.theafa.org/media/releases/afa_release_donationoptions.html) from the American Fertility Association. As the creation of such rulings go, time has already passed for consumer voices to be heard in this case. Still, Dr. Surrey says that he and others hope that action by concerned consumers and their doctors can make a difference in the long run. "It's too late to impact this regulation now," he states, "because it's been made Federal law. But change is always possible, especially when it makes scientific, moral, and political sense."

Surrey and the AFA encourage all patients who hope to benefit from the miracles of third-party ART to become involved with patient advocacy groups to affect positive change for the future in this and other laws related to infertility treatment.

For more information:

Q&A for Roll-Out of Donor Eligibility Final Rule: http://www.fda.gov/cber/rules/suitdonorq&a.htm

21 CFR Parts 16, 1270, and 1271 in Federal Register, Vol 69, No 226 Current Good Tissue Practice for Human Cell, Tissue,and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement http://www.fda.gov/cber/rules/gtp.pdf

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