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 Reardon, Nature 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.
CRISPR: The Latest Biotech Hypeby Anne Fausto-Sterling, Boston 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.