Gene Edited Babies and FDA: Can You Tailor An Embryo in the US?
​[Thursday, November 29, 2018]

By now practically everyone has heard about the US-trained Chinese scientist who create gene edited embryos that led to twin girls. In the hoopla, one thing that is barely discussed is that how easy it was to do it. Using commonly available CRISPR-based gene editing technology, the scientist could create World’s first genetically engineered babies, with more on the way. The case highlights several issues - scientific, practical, and regulatory.  The science is here. It’s ironic that the news broke the same week FDA announced its “Plant and Animal Biotechnology Innovation Plan” which discusses FDA’s support for creating genetically modified plants and animals. The same technology can be, in principle, used in humans. The technology is widely available and being used for all kinds of genetic therapies. FDA has approved two CRISPR-based gene therapy products and many more are in development in the UA and other parts of the World. So far, at least, on the record, genetic manipulation has only been used for gene therapy post birth. But as the news from China highlighted, the same technology could easily be used to manipulate embryos. The issue of embryo manipulation has been discussed extensively in the scientific community and broader public, with most countries in the world not having any rules or even guidance explicitly prohibiting embryo editing. Most of the field is dependent on self-regulation by the scientists who have the training to perform the techniques, which is why this was bound of happen sooner or later. While the scientific community is fuming in public, one can be sure that there are others working in the shadows towards the same goal. That brings us to the regulatory situations. Not having clear laws or regulation is not the answer. Genetically engineered embryos and babies resulting from them are inevitable. The time to create strict laws and policies that could regulate such uses of this technology is now. However, it cannot be just the US or a few countries making local laws; that would only lead to the motivated individuals moving to parts of the world with lax regulation and continue the work. And there would be enough customers willing to pay top dollars to create genetically engineered next generations. There need to be international laws of the kind that exist for drug trade or nuclear energy to control, regulate and prevent accidents. Without it, this is news of a rouge scientist is just the first in a series.