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About US Federal Policies & Human Biotechnology

Federal regulations on most human biotechnologies are inadequate, falling far short of the kind of comprehensive approach that is needed. This situation is due to the unique social and policy challenges posed by human biotechnologies, to the anti-regulatory environment of recent years, and to the divisive politics and religious beliefs that accompany issues involving human embryos.

One regulatory failure is Congress's inability to pass a law prohibiting human reproductive cloning. Nine in ten Americans oppose it, as does every member of Congress and nearly every reputable scientist. Bills that would prohibit reproductive cloning have been introduced several times, but have failed because of disagreements over research cloning.

Another failure is assisted reproduction's scant regulation and oversight. Despite numerous reported abuses and billions of dollars in revenues, federal oversight remains limited to collecting data on success rates.

Medical gene transfer (also called gene therapy) is slightly different. The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) are supposed to oversee each clinical trial. But researchers have often ignored this requirement, as revealed most dramatically after the death of 18-year-old Jesse Gelsinger in a gene transfer experiment.

The most publicized aspect of federal biotechnology policy have been the limitation on federal funding of embryonic stem cell research that was imposed by President Bush in 2001 and removed by President Obama in 2009.

Genes canít be patented, rules Australiaís High Courtby Michael SlezakNew ScientistOctober 7th, 2015In what is considered a stronger decision than in US, Myriad's patent application for BRCA1 is denied in Australia because genes and mutations are "not 'made' by human action."
30k-60K US Sperm and Egg Donor Births Per Year?by Wendy KramerHuffington PostOctober 6th, 2015For the past 28 years the estimated number of children born via donor insemination has remained 30,000: thatís because there is no reliable method of assessing how many children are conceived via donor insemination.
Designer babies crawl closerby Laurie ZolothCosmos MagazineOctober 5th, 2015Are humans mature enough to engineer human embryos? Embryo engineering has been rejected by every ethics committee that has ever considered it.
List of Speakers for NAS Meeting on Human Gene Editingby Paul KnoepflerKnoepfler Lab Stem Cell BlogOctober 1st, 2015A preliminary list of speakers for the National Academies' international summit on human gene editing has emerged, with troubling lack of diversity.
Informed Consent for Egg Donors Wonít Exist Unless We Track Donorsí Healthby Judy E. SternOur Bodies, Our BlogOctober 1st, 2015Recent academic articles raise concerns that conflicts of interest in ART provision may result in donors having an incomplete understanding of the risks of eggs retrieval procedures.
Scientists Find Gene Editing with CRISPR Hard to Resist[quotes Marcy Darnovsky and Pete Shanks]by Cameron ScottHealthlineSeptember 29th, 2015CRISPR, a new technique for editing DNA, is so cheap and easy to use, we may be genetically engineering human embryos before we have time to decide if we should.
DARPA Gives MIT Lab $32 Million to Program Living Cellsby Alexandra OssolaPopular ScienceSeptember 29th, 2015Synthetic biology lab the Broad Institute Foundry announced a new defense contract to join computer scientists and companies in "chemicals, pharmaceuticals, food, energy, agriculture, and biotechnology," but the work remains vague.
Limits of Responsibility: Genome Editing, Asilomar, and the Politics of Deliberationby J. Benjamin HurlbutHastings Center ReportSeptember 28th, 2015What justifies the notion that CRISPR has caught us off guard or that it is appropriate for experts to retreat into secluded spaces to define the parameters of public debate?
The Messy, Complicated Nature of Assisted Reproductive Technology[cites CGS's Marcy Darnovsky]by J. Wesley JuddPacific StandardSeptember 28th, 2015California court case is a representative example of a bigger issue with assisted reproductive technology in this country: It's largely unregulated and ambiguous.
Considering CRISPR: Putting a thumb on the scale?by Pete ShanksBiopolitical TimesSeptember 24th, 2015The National Academies have announced the date for their International Summit on Human Gene Editing. Are some of the organizers trying to predetermine the outcome?
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