FDA to Regulate Gene-Manipulating Fertility Treatments
The FDA on Friday sent a letter to six fertility centers informing physicians that the agency's approval is required to conduct "a controversial class of fertility treatments," marking the government's "first significant foray into regulating the fertility field," the Washington Post reports (Weiss, Washington Post, 7/11). The procedures in question include those that alter the genetic material of gametes and zygotes, such as human cloning and genetic engineering.
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Immediately affected by the new regulations is a technique that combines the eggs of two different women, or "ooplasmic transfer," and the letter was sent to those clinics identified as offering the procedure. In ooplasmic transfer, mitochondrial fluid from a young woman's egg is injected into the egg of an older woman to "rejuvenate" it and allow physicians to fertilize it. As mitochondria contains a small amount of DNA, children conceived through the technique have genetic material from three parents (Regalado, Wall Street Journal, 7/11). The letter was prompted by the announcement in May that two babies created using ooplasmic transfer had been used in the creation of two infants at Saint Barnabas Medical Center in Livingston, N.J. (Campbell, Newark Star-Ledger, 7/11). The method is used on women who have eggs that can be fertilized, but for whom the ensuing embryo dies before implanting in the uterus. Researchers determined that the problem was rooted in the cytoplasm of the egg, and began injecting cytoplasm from the eggs of fertile women into the eggs of women with this specific type of infertility. Thus far, the technique has resulted in the birth of 16 infants (Newark Star-Ledger, 7/11). But some complications have arisen from the technique. Saint Barnabas disclosed that two fetuses conceived this way suffered from Turner's Syndrome, a genetic disorder that causes birth defects, and the women carrying the fetuses subsequently decided to terminate their pregnancies. Doctors are uncertain whether the disorder was related to the fertilization technique (Wall Street Journal, 7/11).