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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.



Why Worry About Genetically Modified Babies?by Marcy Darnovsky and Jessica CussinsGeneWatchNovember 24th, 2014The terms "genetically modified babies" and "designer babies" are attention-getters. But beyond the catchy sound bites, what do they really mean - and are they something we need to worry about?
US Government Cracks Down on Clinical-Trials Reportingby Sara ReardonNature NewsNovember 19th, 2014Proposed regulations would close loopholes that allow researchers to hide negative data.
Patently Absurd? Or Absurdly Patentable?by Pete ShanksBiopolitical TimesNovember 12th, 2014The US Supreme Court might agree to rule on the validity of stem-cell patents, and the Canadian courts are being asked to invalidate a patent on disease-linked genes.
Should Life Insurance Firms Have Access to Your Genetic Test Results?by Melissa HealyLos Angeles TimesNovember 11th, 2014US federal law prohibits the use of genetic information for health insurance coverage decisions. But it doesn't cover life insurance, disability insurance or long-term care insurance.
North Carolina Compensates Victims of Eugenic Sterilization[With CGS's Marcy Darnovsky]by Lily LouThe GuilfordianNovember 7th, 2014The drive behind these sterilizations was the eugenics movement: the pseudoscience of improving a society’s gene pool through reducing populations of people with negative traits.
Why We Should Teach the History of Eugenicsby Jonathan ChernoguzBiopolitical TimesOctober 28th, 2014Two prominent universities have launched initiatives to focus on the history of eugenics.
Technology and Inequalityby David RotmanMIT Technology ReviewOctober 21st, 2014Profound wealth disparities in Silicon Valley highlight the "new world order" in which technological development exacerbates inequality instead of diminishing it.
How Should the U.S. Regulate Genetic Testing?by Jessica CussinsBiopolitical TimesOctober 16th, 2014The question, addressed at a conference at Stanford’s Center for Law and the Biosciences, is both complicated and critical.
When Racism Was a Scienceby Joshua A. KrischThe New York TimesOctober 13th, 2014Haunted Files: The Eugenics Record Office recreates a dark time in a laboratory's past.
Reproducing Raceby Dov FoxThe Huffington PostOctober 6th, 2014It is troubling for donor services to accentuate race in ways that invite parents to exclude wholesale from their consideration all donors of a particular race.
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