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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.

First CRISPR Gene Drive in Mosquitoes Aims to Eradicate Malariaby Antonio RegaladoMIT Technology ReviewNovember 23rd, 2015Designers of a “selfish” gene able to spread among mosquitoes say it could wipe out malaria, but the scientific community is at odds over whether or not we should do it.
F.D.A. Targets Inaccurate Medical Tests, Citing Dangers and Costsby Robert PearThe New York TimesNovember 23rd, 2015Inaccurate, unreliable medical tests are prompting abortions, unnecessary surgeries, putting tens of thousands of people on unneeded drugs and raising medical costs.
Putting a Price on Human Eggs Makes No Senseby Debora SparFortuneNovember 21st, 2015No one wants to deal with the ugly reality that egg donation is not donation at all, but a high price paid for a piece of one’s body. We have identified this transaction and allowed it. Now we are only squabbling over the price.
F.D.A. Takes Issue With the Term ‘Non-G.M.O.’by Stephanie StromThe New York TimesNovember 20th, 2015In addition to balking at "organisms," the FDA argues an industry-serving definition of “genetic modification,” comparing thousands of years of breeding techniques to extremely modern synthetic biology tools.
Scientists may soon be able to 'cut and paste' DNA to cure deadly diseases and design perfect babiesby Tanya LewisBusiness InsiderNovember 19th, 2015CRISPR gene editing tools are being proposed for a wide range of uses, many of which pose risks to ecological systems and human society.
CRISPR Gene Editing: Proofreaders and Undo Buttons, but Ever "Safe" Enough?by Elliot Hosman, Biopolitical TimesNovember 19th, 2015Recent trends include research reports of "spellcheck" and "undo" functions associated with CRISPR gene editing, and a shift toward greater caution about germline applications.
Gene Therapy: Comeback? Cost-Prohibitive?by Elliot Hosman, Biopolitical TimesNovember 19th, 2015Recent CRISPR news sometimes confuses germline modification - which should be put off limits - and gene therapy, which presents its own set of social and ethical risks to resolve before rushing to market.
New Rules Proposed to Address Privacy and Trust in the Precision Medicine Initiativeby Katayoun Chamany, Biopolitical Times guest contributorNovember 19th, 2015The US Precision Medicine Initiative's goal of a million sequenced genomes is helping to propel a revision to the Common Rule governing human subject research.
Gene Manipulation In Human Embryos Provokes Ethical Questions[cites CGS's Marcy Darnovsky]by Rahel GebreyesHuffPost LiveNovember 17th, 2015CGS's Marcy Darnovsky discusses the social implications of leveraging CRISPR gene editing tools to pursue enhanced children.
Why FBI and the Pentagon are afraid of gene drivesby Sharon BegleyStat NewsNovember 12th, 2015Officials from DARPA to the United Nations bioweapons office are concerned about the potential of “gene drives” to alter evolution in ways scientists can’t imagine.
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