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FDA cracks down on company marketing 'three-parent' babies
Source: Washington Post
FDA cracks down on company marketing ‘three-parent’ babies
By Ariana Eunjung Cha August 7 at 5:40 PM
Is the Food and Drug Administration moving to assert more control over new technologies being used by the reproductive health industry?
On Friday, regulators issued a sternly worded letter to fertility doctor John Zhang, who helped a mother with a genetic disorder give birth to a healthy baby boy by using a procedure that combines DNA from her, her husband and an egg donor. The embryo was created in New York, where Zhang's company is based, and was taken to Mexico, where it was implanted in the mother.
The FDA says that's not allowed. Since 2015, Congress has forbidden the FDA from accepting submissions for clinical investigations that involve intentionally creating a human embryo with a heritable genetic modification. But Zhang's research does just this.
The letter notes that Zhang — who is chief executive of a clinic called New Hope Fertility Center and a research company called Darwin Life — had already agreed not to create any more “three-parent” embryos in the United States, but the letter takes issue with the company's continued marketing of the service. On websites, the companies say the technology will “prevent maternally transmitted diseases” and help prolong “natural fertility.”
-snip-
By Ariana Eunjung Cha August 7 at 5:40 PM
Is the Food and Drug Administration moving to assert more control over new technologies being used by the reproductive health industry?
On Friday, regulators issued a sternly worded letter to fertility doctor John Zhang, who helped a mother with a genetic disorder give birth to a healthy baby boy by using a procedure that combines DNA from her, her husband and an egg donor. The embryo was created in New York, where Zhang's company is based, and was taken to Mexico, where it was implanted in the mother.
The FDA says that's not allowed. Since 2015, Congress has forbidden the FDA from accepting submissions for clinical investigations that involve intentionally creating a human embryo with a heritable genetic modification. But Zhang's research does just this.
The letter notes that Zhang — who is chief executive of a clinic called New Hope Fertility Center and a research company called Darwin Life — had already agreed not to create any more “three-parent” embryos in the United States, but the letter takes issue with the company's continued marketing of the service. On websites, the companies say the technology will “prevent maternally transmitted diseases” and help prolong “natural fertility.”
-snip-
Read more: https://www.washingtonpost.com/news/to-your-health/wp/2017/08/07/fda-cracks-down-on-company-marketing-three-parent-babies/
