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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.



The Supreme Court decision that's shaking up biotechby Damian GardeSTATJune 27th, 2016A lower court's decision will stand: Sequenom can't patent its prenatal gene test because it is based on a natural biological process.
All about the base: New businesses eye the opportunities in managing genome dataThe EconomistJune 25th, 2016Currently, one firm - Illumina - controls 70% of a market worth $3.3 billion in 2015.
Bill covering in vitro fertilization for injured veterans clears the House by Seattle Times StaffThe Seattle TimesJune 23rd, 2016Veterans Affairs is closer to paying for in vitro fertilization for injured soldiers seeking to have children.
Read Sonia Sotomayorís Atomic Bomb of a Dissent Slamming Racial Profiling and Mass Imprisonmentby Mark Joseph SternSlateJune 20th, 2016Her dissent explains the extent to which police violate predominantly black and brown people's bodily integrity during "stop and frisk" procedures.
Workers May Soon Have To Share Health Data ó Or Pay A Penaltyby Stephanie M. LeeBuzzFeed NewsJune 18th, 2016Ever thought about joining your workís wellness program? The consequences of opting out could soon get stiffer.
First Human Test of CRISPR Proposedby Antonio RegaladoMIT Technology ReviewJune 16th, 2016The proposed cancer treatment is an immune therapy in which a patientís own blood cells will be removed and genetically altered.
The Politics of Womenís Eggsby Diane ToberUndarkJune 10th, 2016A California bill would allow researchers to obtain eggs by paying women to provide them, though little research exists on the procedure's long-term health impacts.
Undertake a Clinical Trial at Your Own Riskby Steve SternbergUS News & World ReportJune 10th, 2016"Money should be set aside to care for people like me, if we're damaged in a clinical trial. We shouldn't be discarded."
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 health files without a warrant, including those of two transgender men who are taking testosterone.
The National Academiesí 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 The report ducks questions about militarization, commercialization, and food security, but acknowledges there is "insufficient evidence to support the environmental release of gene drives."
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