190 Children’s Legal Rights Journal [Vol. 37:2 2017]
approved in the United States,47 and despite recent legislative efforts to tighten regulations of gene
editing technologies,48 the first baby resulting from MRT was born in September of 2016.49A
Jordanian couple was able to conceive the child through MRT with the help of an American team,
which traveled to Mexico to avoid regulatory obstacles in the United States.50
The latter example illustrates the slow pace of discussion and the inadequacy of laws and
regulations when compared to the pace at which the technology advances. As mentioned above,
there are no comprehensive laws in the United States addressing the genetic engineering of human
embryos.51 This regulatory void is especially alarming in the realm of germline genetic engineering
technologies because, in addition to leaving genetically modified children legally unprotected, they
have the potential to alter the genetic makeup of future generations permanently52 and in
When legislators in the U.K. approved MRT, then Prime Minister David Cameron justified
the approval stating: “We’re not playing God here, we’re just making sure that two parents who
http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=21871. Such limitations include clinical
investigations being limited to women who are at serious risk of passing mitochondrial disease to their children and
that the technique be restricted to male embryos only (since mitochondria only pass down from the maternal line,
men being born as a result of the therapy do would not pass their donated mitochondria to future generations). Id.
Although such approval is for non-reproductive purposes, the author notes that: “researchers say that the decision to
allow embryo-editing research could inform the debate over deploying gene-editing in embryos for therapeutic
47 Mitochondrial Replacement Therapy, UMDF Position Statement on Mitochondrial Replacement Therapy, UNITED
MITOCHONDRIAL DISEASE FOUND,
visited Apr. 11, 2017).
48 See Sara Reardon, U.S. Congress Moves to Block Human-Embryo Editing, NATURE (June 25, 2015),
http://www.nature.com/news/us-congress-moves-to-block-human-embryo-editing-1.17858; see also Cohen &
Adashi, supra note 23; H.R. Res. 2029. The relevant language in the Consolidated Appropriations Act of 2016
states: “none of the funds made available by this Act may be used to notify a sponsor or otherwise acknowledge
receipt of a submission for an exemption for investigational use of a drug or biological product under section 505( i)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355( i)) or section 351(a)(3) of the Public Health Service
Act (42 U.S.C. 262(a)(3)) in research in which a human embryo is intentionally created or modified to include a
heritable genetic modification. Any such submission shall be deemed to have not been received by the Secretary,
and the exemption may not go into effect.” Id. at § 749. However as Mehlman notes, it is uncertain whether
regulation of genetic engineering technologies through the FDA would be effective—as the FDA does not regulate
the practice of medicine—thus potentially placing a large part of the technology outside the FDA’s jurisdiction.
MAXWELL J. MEHLMAN, THE PRICE OF PERFECTION 193 (The Johns Hopkins University Press 2009).
49 Michelle Roberts, First “Three Person Baby” Born Using New Method, BBC (Sept. 27, 2016),
50 Id. In August of 2017, the FDA warned the physician who performed the procedure to stop marketing the
treatment after having told the FDA that he would not use the MRT technology until a trial is formally approved.
See Susan Scutti, James Masters and Susannah Cullinane, FDA Warns ‘3-Parent’ Baby Fertility Doctor Over
Marketing, CNN (Aug. 7, 2017), http://www.cnn.com/2017/08/07/health/fda-3-parent-fertility-zhang/index.html.
See also, Mary A. Malaarkey, August 4, 2017 Letter to Dr. John Zhang,
51 See Zaret, supra note 23.
52 See Lanphier et al., supra note 22.
53 Skerret, supra note 25.