The Food and Drug Administration on Aug. 4 issued a letter to a New York fertility physician, warning him to stop promoting a controversial three-parent in-vitro fertilization technique.
Here are five things to know.
1. John Zhang, PhD, MD, the founder of New Hope Fertility Center in New York City, used the technique to conceive a baby born in Mexico in April 2016.
2. The technique involves replacing faulty mitochondrial DNA in a woman's egg with the healthy mitochondria of another woman before fertilization. The method aims to prevent the development of mitochondrial diseases in the baby, which can involve muscle weakness, diabetes, heart problems and epilepsy.
3. To conceive the baby in Mexico, Dr. Zhang created a genetically modified embryo in the U.S. and sent it across the border to be implanted into the child's mother. Dr. Zhang's team then flew to Mexico where the baby was born at 37 weeks gestation, according to a case study written by Dr. Zhang and published in RBM Online.
4. Dr. Zhang used the technique in 2016 to prevent Leigh syndrome, which is a severe neurological condition that affects at least 1 in 40,000 newborns. The mother treated by Dr. Zhang's team in Mexico previously miscarried four times and had given birth to two children. One of her children died within a year and the other lived to be six years old. Both deaths were attributable to Leigh syndrome, according to a report from CNN.
5. The FDA letter, signed by Mary Malarky, the director of the FDA's Office of Compliance and Biologics Quality at the agency's Center for Biologics Evaluation and Research, said the embryo did not meet federal regulations regarding human cells, tissues, or cellular or tissue based products.
"We request that you notify this office, in writing, of the steps you have taken or will take to address the violation noted above and to prevent recurrence," said Ms. Malarkey in the letter.
To read the FDA's full letter, click here.
To read CNN's report, click here.
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