FDA Tells Doctor to Stop Marketing Three-Parent Babies


The FDA wants a fertility doctor to stop marketing three-parent babies.

The Food and Drug Administration told Dr. John Zhang in an Aug. 4 letter he should stop marketing an unapproved mitochondrial replacement technology, which combines the DNA of three people to create an embryo. The goal of the technology is to prevent mitochondrial disease, which can cause seizures, strokes, severe developmental delays, and other complications.

The technique involves replacing small amounts of mitochondrial DNA in an embryo with DNA from a donor. Mitochondria are “organelles” within cells that provide chemical energy for cellular processes and contain small amounts of DNA.

In annual appropriations acts since December 2015, Congress has prohibited the FDA from using funds to review applications related to genome-editing tools that modify the DNA of human embryos until safety and ethical issues can be resolved. Also, researchers don’t know what impact the procedure will have on the babies it produces.

University of Wisconsin bioethicist R. Alta Charo told me she’s “pleased to see the FDA exercising its authority to protect American patients.” But Charo said she finds “it frustrating that language in the federal budget’s continuing resolution has effectively tied FDA’s hands, making it impossible for the agency to properly review proposals for mitochondrial replacement.”

“By preventing FDA from doing its job, Congress has not protected patients. Instead, it has simply created incentives for practitioners and patients to look for ways around the regulations, thereby losing the valuable oversight FDA offers,” Charo said.

Charo said “it is important that this innovation be developed carefully, and with long-term follow-up to confirm the safety of the procedure for the children who are conceived this way. That is most likely to occur if the work proceeds within clinical trials overseen by a competent regulatory body.”

Read my full article here.

Stay on top of new developments in health law and regulation with a free trial to the Health Law Resource Center.

Learn more about Bloomberg Law and sign up for a free trial.