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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.



Read Sonia Sotomayor’s Atomic Bomb of a Dissent Slamming Racial Profiling and Mass Imprisonmentby Mark Joseph SternSlateJune 20th, 2016Her dissent following the 5-3 Utah v. Strieff decision explained the extent to which officers systematically violate predominantly black and brown people's bodily integrity during "stop and frisk" procedures.
Workers May Soon Have To Share Health Data — Or Pay A Penaltyby Stephanie M. LeeBuzzFeed NewsJune 18th, 2016Ever thought about joining your work’s wellness program? The consequences of opting out could soon get stiffer.
First Human Test of CRISPR Proposedby Antonio RegaladoMIT Technology ReviewJune 16th, 2016Researchers propose using CRISPR/Cas9 to alter gene sequences associated with certain illnesses, such as some forms of cancer.
The Politics of Women’s Eggsby Diane ToberUndarkJune 10th, 2016Scientists are eager to pay women for their eggs, but they are less interested in understanding the long-term health impacts of egg donation.
Undertake a Clinical Trial at Your Own Riskby Steve SternbergUS News & World ReportJune 10th, 2016Volunteer: It 'may very well take a boycott' to get compensation for research injuries.
Now They’re Sequencing DNA in Outer Spaceby Antonio RegaladoMIT Technology ReviewJune 10th, 2016Eyeing eventual Mars mission, NASA plans first test of genetic diagnostics in space.
DEA Wants Inside Your Medical Records to Fight the War on Drugsby Christopher MoraffThe Daily Beast June 9th, 2016The agency wants access to millions of private files without a warrant, including those of two transgender men who are taking testosterone.
The National Academies’ Gene Drive study has ignored important and obvious issues by Jim ThomasThe Guardian June 9th, 2016Some important gaps in the study include an analysis of militarization and commercialization, along with other possible consequences of gene drives.
Interview: “Democratic deliberation” and bioethicsby Nelson Michael & Xavier SymonsBioEdgeJune 8th, 2016A conversation with Nelson Michael about the state of bioethics in the US now and in the future.
Unheard Publics in the Human Genome Editing Policy Debateby Elliot HosmanJune 8th, 2016The socially dangerous prospect of using genome editing tools for human reproduction underlies the need for caution in modifying embryos in basic research.
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