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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.



Myriad Loses Appeals Court Bid to Block Breast Cancer Testsby Susan DeckerBloomberg BusinessweekDecember 17th, 2014Myriad Genetics can’t block competitors’ DNA tests to determine risk for breast and ovarian cancer after a US appeals court said three patents on the tests never should have been issued.
Yesterday's War; Tomorrow's Technology by Nicholas G. Evans and Jonathan D. MorenoJournal of Law and the BiosciencesDecember 15th, 2014What's wrong with the prospect of the US military using genetic screening and germline genetic engineering to select or "enhance" soldiers?
Taking your Genome to the Bankby Harry GlorikianGenetic Engineering & Biotechnology NewsDecember 15th, 2014Your genome has huge implications for you and your children. Institutions that store it should be regulated on how they store it, use it, and potentially share it.
23andMe and the Future of Home DNA Testingby David McNameeMedical News TodayDecember 10th, 2014The Google-associated home DNA test company 23andMe will launch its kit in the UK. In the US, however, health results from 23andMe remain unavailable.
Did NBC News Err On Key Part of Their Stem Cell Report?by Paul KnoepflerKnoepfler Lab Stem Cell BlogDecember 7th, 2014Overall this was a well-done report, but NBC made the bombshell claim that the FDA does not regulate unapproved stem cell “treatments.” This seems very difficult to believe.
CRISPR Opportunities … For What? And For Whom? by Pete ShanksBiopolitical TimesDecember 4th, 2014Money and deals are flowing into the companies founded on CRISPR technology, which promises to enable the precise editing of genomes.
New Interview with FDA on Key Stem Cell Regulatory Issues & Its Own Researchby Paul KnoepflerKnoepfler Lab Stem Cell BlogDecember 1st, 2014An interview with the FDA on key pressing stem cell issues, including Right To Try Laws, the agency's approach to dubious stem cell clinics, and its own research on stem cells.
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.
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