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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.



Genetically Modified Humans? Seven Reasons to Say “No”by Center for Genetics and SocietyCrossing the threshold into inheritable human genetic alterations has long been considered dangerously unacceptable for both safety and social reasons.
Why the 'Devious Defecator' Case is a Landmark for US Genetic-Privacy Lawby Natasha GilbertNature NewsJune 25th, 2015A jury awarded $2.25 million to employees whose privacy was violated when their employer conducted genetic testing to determine fault in a job-site incident.
US Congress Moves to Block Human-Embryo Editingby Sara ReardonNature NewsJune 25th, 2015The House appropriations committee has approved a spending bill that would prohibit the FDA from spending money to evaluate research or clinical applications on gene editing on human embryos.
"Jurassic World" and the Dinosaurs at the USDAby Rachel SmolkerTruthoutJune 22nd, 2015The regulations of the US Department of Agriculture are in desperate need of an overhaul if they are to protect the public from the derailing of billions of years of evolution for the purpose of corporate profit-making.
Building the Face of a Criminal From DNABBCJune 18th, 2015The face of a killer constructed from DNA left at the scene of a crime: it sounds like science fiction. But revealing the face of a criminal based on their genes may be closer than we think.
The Science and Ethics of Genetically Engineered Human DNAby Pete ShanksBiopolitical TimesJune 18th, 2015Discussion of germline genetic modification continues, most recently in the House of Representatives Research and Technology Subcommittee, Committee on Science, Space, and Technology.
Prenatal DNA Test Patent Invalid, U.S. Appeals Court Saysby Andrew ChungReutersJune 12th, 2015The appeals court said the DNA's presence in the blood fell under the U.S. Supreme Court's rule against patenting natural phenomena.
U.S. Bioweapons Research: Are Anthrax Lab Accidents All We Have to Fear?by Gwen D’Arcangelis, Biopolitical Times guest contributorJune 10th, 2015Mishaps involving loss or release of bacteria, viruses, and toxins reported by U.S. laboratories to the Centers for Disease Control number more than 200 incidents per year.
Human Factory Farming and the Campaign to Outlaw Surrogacyby Mirah RibenDissident VoiceMay 30th, 2015America is known as the most lax country for adoption and surrogacy. It has been called the Wild West for its lack of regulation of these practices. Is this a legacy we want to continue?
FBI Notifies Crime Labs of Errors used in DNA Match Calculations Since 1999by Spencer S. HsuWashington PostMay 29th, 2015While the bureau has said it believes the errors are unlikely to result in dramatic changes that would affect cases, crime labs and lawyers said they want to know more about the problem.
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