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Will the U.S. Approve Babies With Three Genetic Parents?

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By Jonathan R. Tung, Esq. on February 04, 2016 1:06 PM

In what could be an historic event in the history of American medicine, it appears that the Food and Drug Administration stands poised to approve the controversial procedures of mitochondrial replacement therapy, otherwise known as MRT, reports the National Academies of Sciences, Engineering, and Medicine. Babies who are born of this procedure inherit the genes of three parents -- a fact that troubles some.

The technique has already been legalized in the UK. But what has been the hold-up in America? Federal Law.

Three-Person Babies

A highly abridged description of the procedure goes like this: a healthy woman donates an egg containing both healthy nucleus and mitochondria. The nucleus is removed and replaced by the nucleus from another woman's egg in which the corresponding mitochondria contained defective DNA. After fertilization, the resulting baby has inherits her father's genes, her mother's genes (the implanted nucleus), and a miniscule trace of genes from her "mitochondrial mother."

One of the major debates surrounding the procedure is talk of "designer babies" hitting the market. Fears of companies coming into existence whose sole business model is to sell some vision of a flawless specimen of a baby borne of eugenics.

Limitations: Boys Only

Earlier in 2015, the FDA charged the Institute of Medicine with the responsibility of investigating the ethics of the MRT. In a report just released yesterday, the IOM gave the ethical greenlight to MRT with provisos: One, the technique should be limited to "making" baby boys -- this is aimed at preventing "germline modification" because mitochondrial DNA is inherited from the mother only; and two, the technique should be limited to women only with "serious mitochondrial diseases," taking into account the health of the mother and scientists' expertise.

Federal Law

But even if the FDA were satisfied with the IOM's findings, it may have to contend with federal regulations that prohibit the FDA from permitting such three-parent babies from being implanted into would-be mothers. As the story develops, we can bet that it's a lot more than just ethics that will stir up this debate -- it's politics.

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