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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.



Bioethics Commission Releases Final Neuroscience Report as Part of BRAIN Initiative: Focuses on Controversial Topics that Must be Addressed if Neuroscience is to Progress and be Applied Ethicallyby Misti Ault AndersonThe blog of the Presidential Commission for the Study of Bioethical Issues March 26th, 2015The President requested that the Bioethics Commission consider the ethical issues associated with neuroscience research and the application and implications of neuroscience research findings.
Precision Medicine is Coming, But Not Anytime Soonby Beverly MerzHarvard Health BlogMarch 26th, 2015New tests and treatments won’t leap directly from the lab to the clinic. The Precision Medicine Initiative also calls for a new regulatory framework to make sure that technologies aren’t launched before they’ve been proven to be safe and effective.
Practical Plan for Managing Human Germline Genetic Modificationby Paul KnoepflerKnoepfler Lab Stem Cell BlogMarch 20th, 2015There is a growing sense of urgency amongst biomedical scientists to take a proactive approach to current and future use of CRISPR technology in human germ cells and embryos.
A Tipping Point on Human Germline Modification?by Jessica CussinsBiopolitical TimesMarch 19th, 2015Amidst reports that human embryos have been modified using the gene editing technique CRISPR, several groups of scientists have issued statements proposing moratoria on human germline genome editing.
Public interest group condemns human germline modification efforts, supports research moratorium, calls for US prohibition[Press Statement]March 19th, 2015We're at a watershed moment in determining whether human genetic technologies will be used in the public interest and for the common good, or in ways that are dangerous and socially pernicious.
Universal Newborn Genome Sequencing and Generation Alphaby Ricki Lewis, Biopolitical Times guest contributorMarch 16th, 2015What might the future look like, as whole-genome sequencing of newborns ramps up?
With World Watching, UK Allows Experiments to Genetically Alter Babiesby Jessica CussinsBiopolitical TimesMarch 4th, 2015Despite several possibly insurmountable legal and safety hurdles, the House of Lords gave the final approval needed to move into fertility clinics the embryo modification techniques referred to as “mitochondrial donation.”
Anne Wojcicki’s Quest to Put People in Charge of Their Own Health[Quotes CGS's Marcy Darnovsky]by Stephanie LeeSan Francisco ChronicleFebruary 28th, 201523andMe has attracted nearly a million customers and more than $126 million in venture capital, but not everyone thinks it should be the one to collect their data.
How Much Do Stem Cell Treatments Really Cost?by Paul KnoepflerKnoepfler Lab Stem Cell BlogFebruary 22nd, 2015Part of the way that clinics cut corners to boost their profits is by not following FDA regulations, putting patients in danger.
Your DNA is Everywhere. Can the Police Analyze it?by David KravetsArs TechnicaFebruary 20th, 2015A human sheds as much as 100 pounds of DNA-containing material in a lifetime and about 30,000 skin cells an hour. Who owns that DNA is the latest privacy issue before the US Supreme Court.
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