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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.



Key Questions About the Social and Ethical Implications of Nuclear Genome Transfer or “3-Person IVF” Techniquesby Jessica CussinsBiopolitical TimesJanuary 22nd, 2015As the Institute of Medicine launches an official assessment over the next year, here are eight questions to consider.
Institute of Medicine to Study the Social Policy and Ethics of “3-Person IVF”by Jessica CussinsBiopolitical TimesJanuary 22nd, 2015The FDA held a public meeting last year to assess the safety and efficacy of nuclear genome transfer for the prevention of transmission of mitochondrial diseases. Now it has asked the Institute of Medicine to consider the social and ethical issues.
US Precision-Medicine Proposal Sparks Questionsby Sara ReardonNatureJanuary 22nd, 2015President Obama announced a "Precision Medicine Initiative" in his State of the Union address, but the White House is remaining tight-lipped about the details.
Perils of Artificial Intelligenceby Pete ShanksBiopolitical TimesJanuary 22nd, 2015The Future of Life Institute is calling for "research on how to make AI systems robust and beneficial," on the heels of several warnings about potential dire dangers.
After Canada, UK, 23andMe Wants DNA Test Growth Abroadby Caroline Humer and Christina FarrReutersJanuary 15th, 2015The company, whose consumer-directed tests were barred by U.S. health regulators in 2013, said Western Europe is one focus for expansion.
Direct-to-Consumer Genetic Tests Should Come With a Health Warningby Jessica CussinsThe Pharmaceutical JournalJanuary 15th, 2015Genetic testing is appropriate in certain situations, but for healthy people as a way to predict disease, it is imprecise and comes with a number of risks.
23andMe’s New Formula: Patient Consent = $by Antonio RegaladoMIT Technology ReviewJanuary 6th, 2015How a consumer genetics company amassed a lucrative database of willing research participants.
Pharmacogenomics and the Biology of Raceby Myles JacksonThe Huffington PostJanuary 5th, 2015Why is race the privileged category used by biomedical researchers in understanding human diversity?
State Courts Strike Blows to Criminal DNA Collection Laws in 2014—What to Look for in 2015by Jennifer LynchElectronic Frontier FoundationJanuary 5th, 2015The "slippery slope toward ever-expanding warrantless DNA testing" is already upon us. But recent state cases provide reason for hope.
Commercialized Conception Casualties: "Brave" Baby Making?by Mirah RibenHuffington PostDecember 22nd, 2014Hiring surrogates and purchasing sperm, eggs, or others' leftover frozen embryos have become accepted as choices on a menu of options.
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