06 July 2015
ByAppeared in BioNews 809
The US Congress has released a bill that would prohibit the Food and Drug Administration (FDA) from spending any money in relation to projects that involve editing the human genome.
According to a report appearing in Nature, the US House of Representatives Appropriations Committee, which funds the FDA, has proposed in its 2016 spending bill to remove funding for evaluating research or clinical applications in this area.
If passed, the legislation would also require the FDA to convene a panel of experts, including those from religious organisations, to examine a review from the Institute of Medicine (IOM) on the ethics of mitochondrial donation.
The proposed legislation comes in the wake of an announcement from Chinese scientists that they had begun research on human embryos using the CRISPR/Cas9 gene-editing technique (see BioNews 799). In recent months, this has put afterburners on the debate concerning the medical and ethical impacts of editing the human germline.
However, the Nature article raised questions over whether the implications of the bill are more political than practical; as applications to the FDA are automatically approved after 30 days unless the FDA seeks to block them, moving to block an application would require spending public funds, which the bill would prohibit.
Bioethicist Hank Greely from Stanford University, California, therefore suggests that the legislation may be a case of the Congress' Republican majority 'trying to throw a bone to some of its supporters'.
Additionally, the type of research carried out by the Chinese scientists would not have been covered by this proposed legislation as they used nonviable embryos. The US legislation would only extend to viable embryos or sperm and eggs that could be used to create a viable embryo.
Currently, US law prevents the federal government from funding research that leads to destruction of human embryos or embryos created solely for research (see BioNews 688). However, privately funded research involving editing the human germline is legal.
In April, the National Institutes of Health affirmed that gene editing of embryos falls under the Dickey-Wicker amendment, meaning that no federal funds will be made available for such research (see BioNews 800).
The bill also requires the FDA to create a committee including religious experts to examine a report that it commissioned from the IOM around the ethics of mitochondrial donation.
Jonathan Moreno, a bioethicist from the University of Pennsylvania, Philadelphia, told Nature that he couldn't understand why Congress was adding this extra layer of 'taxpayer-supported ethics reflection'. 'You don’t have to be a faith-based bioethicist to recognise that there's some global responsibility for modifying the human germline,' he commented.
However, William Kearney from the National Academy of Sciences, which oversees the IOM, commented: 'We always strive to balance our committees with the expertise necessary to carry out the study in a scientific manner in order to produce an evidence-based report.'
The bill still has a way to go to before it can become law, and will need to be approved by Congress, the Senate and then by the President to take effect.