Three Parent Baby Procedure Experimental in US I KingSpry

FDA Directs New York Doctor to Stop Marketing “Three-Parent Baby” Procedure

Photo of attorney Avery E. Smith

Posted on August 10th, 2017
by Avery E. Smith

On August 4, 2017,  the U.S. Food and Drug Administration (FDA) reprimanded Dr. John Zhang, CEO Of New Hope Fertility Clinic in New York, for marketing his controversial “three-parent baby” technique.

Dr. Zhang’s procedure, still deemed experimental, combines the DNA of three individuals into a single embryo by using a technique called nuclear transfer.

Humans carry DNA in two different places:  the nucleus of the cell, and in structures outside of the nucleus, called mitochondria. Dr. Zhang’s method distinguishes between the two DNA locations by combining the bulk of the mother’s DNA, found in the egg’s nucleus, with the mitochondrial DNA from an egg donor.  Mutations in mitochondrial DNA are passed down by the mother; this technique is intended to prevent a child from inheriting certain genetic diseases. The egg is then fertilized, and then implanted in the mother’s uterus.

Recently, Zhang and his colleagues in New York injected the mother’s nuclear genome into the hollowed egg from a donor (using only the donor’s mitochondrial DNA), and then fertilized the egg.  The embryo was then sent to Mexico where it was implanted in the mother’s uterus.  The procedure is not illegal in Mexico. However, in its reprimand, the FDA notified Zhang that embryo exports are prohibited.

Last year, a panel of US government advisors issued a report stating that it was ethical to test the three-parent baby approach in pregnancy as long as the students followed strict safety steps, included women at high risk of passing on severe, genetic diseases, and implanted only male embryos (so that the genetic alterations would not pass to future generations).

However, this report has not affected the legal prohibitions against the procedure as enforced by the FDA.

Dr. Zhang’s first “three-parent baby” was born last year.  His mother is a carrier of a genetic disease known as Leigh syndrome, a severe neurological disorder that generally results in death within a few years of birth. According to reports, the baby is healthy.


heARTbeat is a publication of KingSpry’s Adoption Law and Assisted Reproductive Technology Law Practice Group. It is meant to be informational and does not constitute legal advice.