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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.



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 DNA Sequencer in Every Pocketby Ed YongThe AtlanticApril 28th, 2016Oxford Nanopore Technologies, who severed financial ties with DNA sequencing monolith Illumina in 2013, is "desperately thinking of ways of bringing them down”, in particular: the MinION.
Meet The New CEO Of The $22 Billion Genomics Company You've Never Heard Ofby Christine FarrFast CompanyApril 27th, 2016Gene-sequencing giant Illumina is expanding to direct-to-consumer tests and perhaps brand partnerships, says new CEO Francis deSouza.
Editorial: Editing human genes the CRISPR wayby Editorial BoardThe Chicago TribuneApril 27th, 2016Can we trust scientists and governments to set ethical boundaries for research and therapeutic use — and then stick to them? We're skeptical.
Dwarfism, Chemical Limb Lengthening, and Informed Consentby Joseph StramondoInternational Journal of Feminist Approaches to Bioethics BlogApril 25th, 2016CA biotech BioMarin Pharmaceuticals has completed Phase 2 of a drug clinical trial designed to "normalize" annual growth but not address health complications of dwarfism.
God’s Red Pencil? CRISPR and The Three Myths of Precise Genome Editingby Jonathan LathamIndependent Science NewsApril 25th, 2016CRISPR is the latest platform in a 70-year-old "gospel of precision" used to justify moving quickly with new chemical and biological technologies, despite decades of disasters and unintended consequences.
US moves to sell gene-edited mushrooms fuel doubts over British ban on GM importsby Robin McKieThe Guardian April 23rd, 2016The USDA approved CRISPR-modified crops, but a European regulatory committee's delays are dismaying some UK researchers.
Researchers push for personalized tumour vaccinesby Heidi LedfordNature NewsApril 22nd, 2016Enthusiasm comes amid concerns the therapy may prove too complex to manufacture and that a rapid shift toward the personalized approach is neglecting decades of broader application research.
Save the Mosquitosby Ashley DawsonJacobinApril 22nd, 2016We should fight Zika with better public health, not genetically modified mosquitos.
Eric Lander talks CRISPR and the infamous Nobel ‘rule of three’by Joel AchenbachThe Washington PostApril 21st, 2016At the Aspen Institute, Lander urged scientific modesty with new gene editing tools: “We are terrible predictors of the consequences of the changes we make.”
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