FDA announces intent to regulate certain fertility practices

הסקירה באדיבות אתר מדיקונטקסט.
By Ori Twersky

WASHINGTON (Reuters Health) – After years of asserting its authority over fertility clinics without taking any substantial action, the US Food and Drug Administration (FDA) finally has announced its intent to regulate most transfers of genetic material that does not involve the simple union of sperm with an egg.

In a recent letter to fertility clinics, the FDA announced that it would require fertility doctors to submit an investigational new drug application (IND) for most transfers of genetic material that do involve the simple introduction of sperm to an egg.

An IND is the means by which the agency generally regulates clinical trials.

The FDA cited concerns about the protection of human subjects as the primary reason for the heightened oversight, but noted that it cannot advise fertility doctors as to whether their activities would require the filing of an IND.

Based on the outline provided by the FDA, experts say the most likely practice that would fall under the FDA's scrutiny is ooplasmic transfer, in which cytoplasm from a donor egg is used to help fertilize an egg from an infertile woman. Ooplasm contains mitochondrial genetic material, and children born using this technique have been shown to contain genetic material from both women.

However, the FDA is likely to encounter substantial opposition.

While the FDA asserted its authority under a federal regulation giving it the power to regulate the exchange of genetic material, fertility doctors have questioned whether that regulation can be applied to fertility practices.

"In cases in which there is just one couple involved, we don't think the FDA has a role to play," explained Sean Tipton, a spokesman for the American Society of Reproductive Medicine, in an interview with Reuters Health. "It is not clear what product they would regulate: The sperm? The egg? The child?"

But should the FDA limit its proposed regulations to ensure that sperm and other material used by fertility doctors are free from disease, Tipton added that the agency would find a far more receptive audience.

"We feel that it is perfectly appropriate for the FDA to require disease testing," Tipton told Reuters Health. "It is not clear that they have the authority to regulate the practice of medicine."

Tipton also noted that there is no evidence as of yet that ooplasmic transfer can transmit disease to the resulting embryo.

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