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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.



Why Gene Tests for Cancer Don't Offer More Answersby Jessica WapnerScientific AmericanAugust 29th, 2016Genetic profiling of tumors has a long way to go. Many patients learn that their cancers have mutations for which no drug exists
FBI’s New DNA Process Produces More Matches in Suspect Databaseby Devlin BarrettWall Street JournalAugust 25th, 2016In May, the Bureau reduced the number of genetic locations required for a potential match (from 10-13 to 8-9 loci), resulting in thousands of new "hits."
Babies’ Health Could Be Affected by Variation in IVF Nutrientsby Jessica HamzelouNew Scientist August 24th, 2016Pharmaceutical companies keep the "recipe" of IVF culture media a secret, but research suggests long-term health effects for resulting children.
Accessible Synthetic Biology Raises New Concerns for DIY Biological Warfareby Joseph NeighborVICE MotherboardAugust 23rd, 2016The monopoly on biology once held by governments and universities has been broken, posing significant challenges for the international community.
Staying Ahead of Technology’s Curvesby Doug HillBoston GlobeAugust 21st, 2016Embracing new technologies with extraordinary disruptive powers without trying to anticipate and prepare for their potential consequences is now, more than ever, a bad idea.
These New Stem Cell Treatments Are Expensive — and Unprovenby Michael HiltzikLos Angeles TimesAugust 19th, 2016"Stem cells have become a medical buzzword," Paul Knoepfler notes. "I see a lot of businesses using direct marketing to patients to take advantage of that."
In CRISPR Fight, Co-Inventor Says Broad Institute Misled Patent Officeby Antonio RegaladoMIT Technology ReviewIs an email between competing researchers a smoking gun in the billion dollar battle over patent rights for gene editing?
CRISPR patent fight: The legal bills are soaringby Sharon BegleySTATAugust 16th, 2016Editas has already spent $10.9M in 2016, but many in the CRISPR field wonder privately why Broad and UC Berkeley have not reached a settlement.
What happens when anyone can edit genes at home? We’re about to find outby Dyllan FurnessDigital TrendsAugust 15th, 2016Scientists express concern about the unintentional consequences of gene editing starter kits proliferating in biohacking communities.
Illumina Would Like You to Sequence More DNA, Pleaseby Sarah ZhangWIREDAugust 15th, 2016The leader of the DNA sequencing market has a start-up accelerator program to find new applications for its technology.
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