Spending Bill Would Ban Drugs Made by Editing Human Embryo Genes

  • Measure echoes calls for moratorium by White House, scientists
  • Speaker Ryan says provision offers `protection for life'

Controversial gene-editing technologies on human embryos would be banned from approval by drug regulators under a $1.1 trillion spending bill the U.S. Congress is close to approving.

Scientists and ethicists have called for similar measures, and the ban won’t affect companies that are studying genome editing in mature, non-embryonic tissues. But the bill, which has been negotiated by Republican and Democratic lawmakers and is likely to be signed into law by President Barack Obama, would be the first intervention by Congress in an area of growing promise and moral uncertainty in the biotech industry.

Genome-editing allows researchers to cut and replace flawed segments of DNA, the molecule that directs construction of human organs and tissues. The technology is being studied as a potential fix for serious inherited conditions, such as sickle-cell disease and beta thalassemia.

A number of biotech companies, including closely held Editas Medicine of Cambridge, Massachusetts, are using a new genome-editing technology, known as Crispr, to introduce corrective genes into diseased adult tissues. Most have indicated they have no plans to edit embryonic genomes. Such startups have raised more than $1 billion in venture-capital funding.

‘Designer Babies’

Scientific groups, along with the Obama administration, have already called for a moratorium on the use of genome-editing in human sperm, eggs and embryos, and U.S. funding for such research has been banned because of concerns about harm to humans and the possibility of creating “designer babies.” The spending bill goes further, prohibiting the Food and Drug Administration from reviewing applications for drugs developed via human embryos with “modified” genomes.

“Any such submission shall be deemed to have not been received by the Secretary,” according to the bill. The language is attached to a spending bill that aims to fund U.S. agencies through September and avoid a government shutdown.

Speaker of the House Paul Ryan, the Wisconsin Republican, said the gene-editing provision is part of a collection of measures in the bill to create "strong protections for life." The proposal also bars taxpayer funding of abortions, according to a statement from Ryan’s office.

‘Grave Concerns’

Dozens of nations around the world have instituted prohibitions on altering the genes of human sperm, eggs and embryos, and work in the area has sparked widespread controversy.

Scientists at the Francis Crick Institute in London, where the research is banned, said in September that they had applied for a permit to use gene editing to explore basic science questions of human embryonic development. In April, a group of Chinese researchers said they attempted to use Crispr in about 80 human embryos to repair a gene involved in thalassemia. While a handful of the embryos, which were never viable, adopted the replacement gene, unexpected mutations occurred, according to their report.

Edward Lanphier, chief executive officer of Sangamo BioSciences Inc., was the lead writer of an article published in the journal Nature in March that said research on embryonic genomes poses serious risks.

“There are grave concerns regarding the ethical and safety implications of this research,” said Lanphier, whose company uses a genome editing technology called zinc fingers, in the editorial with his co-authors. “There is also fear of the negative impact it could have on important work involving the use of genome-editing techniques in somatic (non-reproductive) cells.”

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