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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.



Giant study poses DNA data-sharing dilemmaby Sara ReardonNature NewsSeptember 1st, 2015As the US Precision Medicine Initiative pushes forward, whether to provide sequenced genetic information to biobank donors is an unresolved question of ethics, privacy, and medical utility.
How We Should Rethink the Role of Technical Expertise in GMO Regulation[India]by Dhvani Mehta and Yashaswini MittalThe WireAugust 31st, 2015The regulation of GMOs represents a good opportunity to rethink the role of public participation and non-technical knowledge in environmental regulatory discourse in general.
The Colonial Origins of Conservation: The Disturbing History Behind US National Parksby Stephen CorryTruthoutAugust 25th, 2015Environmental conservation that excludes tribal peoples has deep connections with historical eugenics.
CRISPR: The Latest Biotech Hypeby Anne Fausto-SterlingBoston ReviewAugust 24th, 2015What began with an attempt to build a better yogurt now has journalists speculating about Brave New World scenarios, but the bio-hype relies on a false model of genetic determinism.
"Eggsploitation: Maggie's Story" Reveals Unknown Risks of Egg Retrieval by Emma ManiereBiopolitical TimesAugust 13th, 2015"Eggsploitation: Maggie's Story" reveals how the fertility industry takes advantage of individuals' altruistic motives in search of profit while the medical risks remain unknown.
Why it Matters that the FDA Just Approved the First 3D-Printed Drugby Dominic BasultoWashington PostAugust 11th, 2015This 3D-printed pill, which will sold by Aprecia Pharmaceuticals under the name Spritam, could be used by the more than 3 million adults and children in America who suffer from certain types of seizures caused by epilepsy.
Ageing and Fertility: Biology Comes Secondby Kirsty OswaldBioNewsAugust 10th, 2015As long as we live in a society that expects women to sacrifice so much more than men to be a parent, we might as well stop talking about biology.
Public Health in the Precision-Medicine Eraby Ronald Bayer, Ph.D. & Sandro Galea, M.D., Dr.P.H.New England Journal of MedicineAugust 6th, 2015"In many ways the American health care system is the most advanced in the world. But whiz-bang technology just cannot fix what ails us.
Congress Should Support Access to Post-Conviction DNA Testingby Kirk BloodsworthThe HillJuly 29th, 2015"If not for post-conviction DNA testing, I might still be in prison, or worse, I could have been executed."
Republicans Just Sabotaged a Bill that Would Have Helped Wounded Vets Start Familiesby Jennifer Gerson UffalussyFusionJuly 23rd, 2015A recent Congressional bill would have extended coverage for fertility treatments to retired veterans.
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