FDA Warns Fertility Doctor To Stop Marketing 3-Parent Baby IVF Technique
Federal health regulators have warned New York-based fertility doctor John Zhang to stop marketing an IVF technique that he earlier used to help a Jordanian couple bear a three-parent baby boy.
Producing A Three-Parent Baby
The procedure, which used DNA from three people — the child's father, the child's mother, and an egg donor — was done to prevent him from having a life-threatening genetic disease. The process involved transferring DNA from the fertilized mother's egg into an egg donated by another woman.
The process, however, has not yet been approved in the United States, and Congress has prevented the FDA from reviewing proposals to conduct experiments involving the technique.
Because his earlier work would violate federal legislation that bars implanting genetically altered embryos, Zhang went to Mexico to finish the process of inserting the embryo into the mother's womb. The procedure was nonetheless successful as it bore a three-parent baby boy in April 2016.
"This is the very first time at least in human reproduction that the offspring are produced with three parties — one sperm and different parts of two eggs," Zhang said after news of the three-parent baby emerged. "So this is very revolutionary."
Doctor Markets IVF Technology Not Yet Approved By The FDA
The FDA said that Zhang, who heads the New Hope Fertility Clinic in New York, and Darwin Life Inc., has given word that his companies would not use the technology in the United States again sans getting permission. The doctor continues to promote it though.
In a letter dated Aug. 4, the FDA warned Zhang about several marketing claims posted online. His companies' websites, for instance, tout of proven treatments for mitochondrial disease and other genetic disorders, prevention of maternally transmitted diseases and cure for mitochondrial disease.
"Using an advanced egg environment-exchange protocol called Spindle Nuclear Transfer, Darwin Life has surpassed both the "3-Parent IVF" technique in the United Kingdom and "Cell Augmentation" in Canada, to create the world's first, healthy, live-birth, baby boy from Spindle Nuclear Transfer," reads a post on the Darwin Life website.
The letter noted how the fertility doctor still markets mitochondrial replacement technology, or MRT, the in vitro fertilization technique that involves getting the future baby's mitochondrial DNA from a third party.
"You continue to market MRT to prevent the transmission of mitochondrial disease and to treat infertility," the letter reads. "Please be advised that you are using MRT to form a genetically modified embryo, which is subject to FDA's regulations with respect to human cells, tissues, or cellular or tissue based products."
Zhang was advised to inform FDA's Office of Compliance and Biologics Quality Center for Biologics Evaluation and Research of the steps he has taken or will take to address the issue.