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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.



With World Watching, UK Allows Experiments to Genetically Alter Babiesby Jessica CussinsBiopolitical TimesMarch 4th, 2015Despite several possibly insurmountable legal and safety hurdles, the House of Lords gave the final approval needed to move into fertility clinics the embryo modification techniques referred to as “mitochondrial donation.”
Anne Wojcicki’s Quest to Put People in Charge of Their Own Health[Quotes CGS's Marcy Darnovsky]by Stephanie LeeSan Francisco ChronicleFebruary 28th, 201523andMe has attracted nearly a million customers and more than $126 million in venture capital, but not everyone thinks it should be the one to collect their data.
How Much Do Stem Cell Treatments Really Cost?by Paul KnoepflerKnoepfler Lab Stem Cell BlogFebruary 22nd, 2015Part of the way that clinics cut corners to boost their profits is by not following FDA regulations, putting patients in danger.
Your DNA is Everywhere. Can the Police Analyze it?by David KravetsArs TechnicaFebruary 20th, 2015A human sheds as much as 100 pounds of DNA-containing material in a lifetime and about 30,000 skin cells an hour. Who owns that DNA is the latest privacy issue before the US Supreme Court.
EFF to Supreme Court: The Fourth Amendment Covers DNA Collectionby Press ReleaseElectronic Frontier FoundationFebruary 18th, 2015People have a Fourth Amendment right to privacy when it comes to their genetic material, the Electronic Frontier Foundation argues in an amicus brief filed this week with the Supreme Court.
Mitochondrial Mission Creep and the Cloning Connection by Pete ShanksBiopolitical TimesFebruary 14th, 2015Shoukhrat Mitalipov wants to use nuclear genome transfer for age-related infertility. He has joined forces with the disgraced stem cell researcher Hwang Woo-suk.
The Unknown Limits of Synthetic Biologyby Helia IghaniCouncil on Foreign RelationsFebruary 13th, 2015The greatest risk to U.S. national security is bioterrorism and the deliberate misuse of synthetic biology.
Forensics Specialist Discusses a Discipline in Crisisby Daniel CresseyNature NewsFebruary 12th, 2015The judiciary are certainly concerned about some of the evidence types that are appearing in their courtrooms. That’s borne out by the rulings they are making.
FDA Regulation and Early Prenatal Testingby George Estreich, Biopolitical Times guest contributorFebruary 5th, 2015The information that accompanies prenatal testing should be accurate, complete, useful, and most of all nondirective. The ads for early prenatal tests do not meet these criteria.
Precision Medicine in Contextby Pete ShanksBiopolitical TimesFebruary 5th, 2015President Obama's proposal for a Precision Medicine Initiative – which echoes President Nixon's "War on Cancer" – should start a conversation that includes lots of questions.
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