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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.



Center for Genetics and Society comments on White House and National Academies approaches to altering the human germline[Press statement]May 27th, 2015“The endorsement of a pause by the White House is an important first step."
The University of Minnesota’s Medical Research Messby Carl ElliottThe New York TimesMay 26th, 2015Rather than dealing forthrightly with these ethical breaches, university officials have seemed more interested in covering up wrongdoing with a variety of underhanded tactics.
A Note on Genome Editingby John P. HoldrenOffice of Science and Technology PolicyMay 26th, 2015The Administration believes that altering the human germline for clinical purposes is a line that should not be crossed at this time.
US Science Academies Take on Human-Genome Editing[Quotes CGS's Marcy Darnovsky]by Sara ReardonNatureMay 18th, 2015The academies will hold an international summit this autumn, and establish a working group to develop a consensus statement.
Stem Cell 'Wild West' Takes Root Amid Lack of US Regulationby Matthew PerroneAssociated PressMay 18th, 2015More than 170 US clinics are selling experimental stem cell procedures — a mushrooming industry that has flourished despite little evidence of its safety or effectiveness.
Francis Collins on CRISPR: "Designer Babies Make Great Hollywood — And Bad Science"by Julia BelluzVoxMay 18th, 2015There's a strong consensus that is a line we should not cross.
National Academies Will Meet to Guide 'Gene Editing' Researchby Lisa M. KriegerSan Jose Mercury NewsMay 18th, 2015The landmark conference will gather researchers and other experts. One observer warns, "This is an ethical, social and human issue, not a technological issue. I don't think the scientists are the right people to be addressing it."
U.S. Introduces New DNA Standard for Ensuring Accuracy of Genetic Testsby Robert PearThe New York TimesMay 14th, 2015The National Institute of Standards and Technology has developed “reference materials” that could be used by laboratories to determine whether their machines and software are properly analyzing a person’s genome.
Is DNA the Next Frontier in Privacy?by Nikhil SwaminathanAljazeera AmericaMay 11th, 2015The president has called for a million people to volunteer their DNA sequences, health records and sensor tracking data, but the government is mum on how it will protect their privacy.
The Blurred Lines of Genetic Data: Practicality, Pleasure and Policingby Jessica CussinsThe Huffington PostMay 8th, 2015Shocking news from Idaho is a reminder that we don’t always control what happens with our data, and won’t always like it.
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