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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.



Public Opposes Human Germline “Enhancement” by Overwhelming Majorityby Pete ShanksBiopolitical TimesMay 5th, 2016New polls confirm that the public remains opposed to "enhancement" and is still not convinced about other proposed genetic interventions.
Scientists are trying to use CRISPR to fix everything. What’s wrong with that?by Emily McManusTED IdeasMay 5th, 2016A historian of eugenics asks: "Will individuals start making decisions to use new biotech to improve themselves and their children?"
Hacking CRISPR: Patents, Gene Therapy & Embryosby Elliot HosmanMay 5th, 2016As gene editing experiments on human embryos spread, piecemeal hacks of CRISPR are outpacing discussions of the futures it might enable.
Why this lab-grown human embryo has reignited an old ethical debate[citing CGS' Marcy Darnovsky]by Patrick MonahanScience/AAASMay 4th, 2016Two teams report growing human embryos just up to 14 days, prompting some scientists and bioethicists to contend that it’s time to revisit the so-called 14-day rule.
New advances in growing human embryos could prompt ethical firestorm[citing CGS' Marcy Darnovsky]by Eric BoodmanSTATMay 4th, 2016Changing the 14-day rule is an explosive question in an era when CRISPR gene-editing has sparked fears about “designer babies.”
Cultural Influences Reflected in Divergent US vs UK Human Embryo Research Policies[citing CGS' Marcy Darnovsky]by Eli Y. AdashiThe JAMA ForumMay 3rd, 2016Reactions to CRISPR gene editing experiments depend upon a country's existing laws and regulation.
Dead could be brought 'back to life' in groundbreaking projectby Sarah KnaptonThe Telegraph [UK]May 3rd, 2016A US biotech firm received permission to recruit 20 clinically dead patients for a stem cell treatment.
With CRISPR in Humans On the Horizon, Will the Public Back Intellia?by Alex LashXconomyApril 29th, 2016Intellia and Editas both lack what so many biotech investors crave: data from human clinical trials. As they race to the clinic, it's hard to tell if either company will pay off.
A Single $249 Test Analyzes 30 Cancer Genes. But Do You Need It?by Sarah ZhangWIREDApril 28th, 2016Color Genomics is marketing gene tests for 30 cancers, but doctors caution that our ability to sequence DNA has far outpaced our ability to understand what the results mean.
A DNA Sequencer in Every Pocketby Ed YongThe AtlanticApril 28th, 2016Oxford Nanopore Technologies, which severed financial ties with DNA sequencing monolith Illumina in 2013, is "desperately thinking of ways of bringing them down.” These include a USB-powered sequencer called the MinION.
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