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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.

Just What We Need: Slicker Infertility Marketingby Gina Maranto, Biopolitical Times guest contributorOctober 21st, 2016A serial tech entrepreneur launches a new start-up called Prelude with a hipster-chic website downplaying the many unknowns of egg freezing.
California stem cell agency approves $30 million to fast-track clinical trialsby David JensenThe Sacramento BeeOctober 19th, 2016Dubbed the new “pitching machine,” CIRM on Wednesday completed creation of a $30 million effort to dramatically speed up FDA approval of stem cell therapies.
What Stem Cell Researchers Talk About When They Talk About Ethicsby Danielle VentonKQEDOctober 18th, 2016"Biology is really complicated! Engineers who design something expect it to work. But if you put something [designed] into an organism, the chances that something odd will happen are extremely high.”
Meet Prelude Fertility, The $200 Million Startup That Wants To Stop The Biological Clock[citing CGS' Marcy Darnovsky]by Miguel HelftForbesOctober 17th, 2016Despite short and long-term risks with egg retrieval, fertility companies target young people as a new demographic, putting profits ahead of safety.
DNA database could help predict your disease — then get you firedby David LazarusLos Angeles TimesOctober 14th, 2016The "Precision Medicine" project of introducing big data into healthcare comes with a host of risks for individuals and communities, including privacy and genetic discrimination.
President signs Senate bill that protects eugenics victimsby Richard CraverWinston-Salem JournalOctober 7th, 2016Passed in a bipartisan effort, state restitution payments will not decrease or eliminate federal benefits for class members who were forcibly sterilized.
CRISPR Embryos at Karolinska: Controversies Demand Oversightby Elliot HosmanOctober 7th, 2016Ongoing gene editing experiments in human embryos around the world underscore the need to prohibit modifying cells for use in human reproduction.
Collaborative Science on Historically Burdened Concepts: Intelligence, Genetics, Race & Socio-economic Statusby Daphne Martschenko, Biopolitical Times guest contributorOctober 6th, 2016Confusion and discomfort often accompany discussions of concepts with burdened histories. In both the social and biological sciences, we can and must do better to learn and collaborate together.
Uterus Transplants Fail Again: Why Are They So Difficult?by Rachael RettnerLive ScienceOctober 5th, 2016Four uterus transplants using live donors (a first in the U.S.) took place in Dallas with assistance from pioneering Swedish team, but three were removed due to lack of blood flow.
Wrong Steps: The First One From Threeby Pete ShanksDeccan ChronicleOctober 2nd, 2016Gene-editing technology is advancing rapidly. What if we come to a consensus about what should not be allowed...and then some renegade scientists, convinced that they know best, just go ahead and do it?
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