FDA Considers Fertility Method Using the Genetic Material of Three People

This week, the Food and Drug Administration is meeting with a panel of experts to examine fertility methods that involve using the genetic material of three separate individuals.

This week, the Food and Drug Administration is meeting with a panel of experts to examine fertility methods that involve using the genetic material of three separate individuals. Critics worry that the use of such methods could lead to the dicey proposition of “designer babies,” whose traits are selected by parents before birth. The meetings on Tuesday and Wednesday are to discuss the procedure itself, and not the ethical implications.

The procedure in question involves mitochondria, the power producers in cells that convert energy into a form that cells can use. Mitochondria with defects that could be passed to a fetus are replaced with healthy mitochondria from another woman. This is done either before or after an egg is fertilized.

This specific technique, researched at Oregon Health and Science University, is meant to allow women with mitochondrial diseases to produce healthy offspring by using another woman's mitochondria. Its success has been replicated in monkeys multiple times.

Scientists have previously combined genetic material from three separate people in a different procedure in 2001, although the FDA eventually shut down that practice and said it could not be performed on humans without express permission from the agency.

But the use of such a procedure is different from, for instance, allowing a parent to choose their child’s eye or hair color, or their sex. Reuters points out:

Replacing mutation-filled mitochondria with healthy ones would not be genetic engineering in the usual understanding of the term. It would not make a child smarter, more athletic, more attractive, or otherwise different from what his genome and environment would otherwise produce.

Dr. Shoukhrat Mitalipov, who led the Oregon study, framed the procedure not as an alteration but as a reversal. “We want to replace these mutated genes, which by nature have become pathogenic to humans,” he said. “We’re reversing them back to normal, so I don’t understand why you would be opposing that.”

While the FDA usually follows panel recommendations, they are not legally obligated to do so. There is no current timetable for the agency to reveal its findings on the matter.