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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.



Obama vs. Trump: 5 ways they clash — or don’t — on health and scienceby Dylan ScottSTATJanuary 9th, 2017While Trump might play some wild cards in medicine, science, and public health, there may be some surprising continuity with President Obama’s administration.
How Gene Editing Could Ruin Human Evolution[cites CGS's Marcy Darnovsky]by Jim KozubekTimeJanuary 9th, 2017There are no superior genes. Genes have a long and layered history, and they often have three or four unrelated functions, which balance against each other under selection.
2016 Fear vs Hope: Gene Editing— Terrible turning point?by Pete ShanksDeccan ChronicleJanuary 1st, 2017As the tools for gene editing rapidly advance, we approach our best chance to prevent the rise of a modern, uncontrolled and dangerously ill-considered techno-eugenics.
Unexpected Risks Found In Replacing DNA To Prevent Inherited Disordersby Jill NeimarkNPRJanuary 1st, 2017Scientists are increasingly concerned that "3-person IVF" techniques may allow flawed mitochondria to resurface and threaten a child's health.
China’s $9 billion effort to beat the U.S. in genetic testing[cites CGS's Marcy Darnovsky]by Ylan Q. MuiWashington PostDecember 30th, 2016Chinese investors — both private and government-supported — are backing American start-ups and funding promising new companies at home.
Will the Alt-Right Promote a New Kind of Racist Genetics?by Sarah ZhangThe AtlanticDecember 29th, 2016The genomic revolution has led to easy sequencing and cheap "ancestry" tests. White nationalists are paying attention.
UC Davis professor wants FDA to create firm guidelines for stem-cell treatments, put clinics on noticeby Claudia BuckSacramento BeeDecember 24th, 2016Now is the time for the U.S. Food and Drug Administration to finalize guidelines and send notices to clinics that are offering untested treatments.
Why tech offers better fertility benefits than other industries[cites CGS's Marcy Darnovsky]by Alison DeNiscoTech RepublicDecember 21st, 2016The benefits are part of the current talent war for engineers and other professionals. Tech workers should be cautious about using the procedures.
Obama’s Outgoing Science Advisor Will Keep Watch in 2017by Dave LevitanWIREDDecember 20th, 2016There is no denying the scientific know-how of the outgoing administration. What comes next has scientists worried.
Bioterrorism And Gene Editing: Can Crispr Tool Be Used As Biological Weapon In War?by Himanshu GoenkaIB TimesDecember 14th, 2016Given its broad distribution, low cost, and accelerated pace of development, deliberate or unintentional misuse of gene editing might have far-reaching economic and national security implications.
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