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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.



How Do You Regulate the Digital Health Revolution?by Laura EntisFortuneJuly 18th, 2016Digital health apps and other startups may claim to be more effective than they actually are.
The White House Is Pushing Precision Medicine, but It Wonít Happen for Yearsby Mike OrcuttMIT Technology ReviewJuly 18th, 2016Costs are high and the science is not developed enough.
Pro and Con: Should Gene Editing Be Performed on Human Embryos? by John Harris & Marcy DarnovskyNational GeographicJuly 15th, 2016Darnovsky and Harris debate germline gene editing.
The Direct-to-Consumer Stem Cell Industry in the USby Pete ShanksJuly 15th, 2016There are more stem-cell clinics than anyone suspected, and itís not clear that they are operating with proper supervision.
The EEOCís Final Rule on GINA and Employer-Sponsored Wellness Programs to Take Effect This Monthby Jennifer K. WagnerGenomics Law ReportJuly 14th, 2016The Genetic Information Nondiscrimination Act now has updated regulations around health information obtained from employees' spouses.
At Gene Editing Meeting, Scientists Discuss God, Racism, Designer Babies[originally published as "At Gene Editing Meeting, Scientists Discuss God, Racism, Designer Babies"]by Nidhi SubbaramanBuzzFeedJuly 14th, 2016Opponents of germline gene editing have strong concerns both around the safety and ethics of altering reproductive cells.
Considering Gene Editingby Jef AkstThe ScientistJuly 12th, 2016A public meeting in Washington, DC continues an international committee investigation into precision DNA editing.
FDA Lets Cancer Trial Resume after 3 Patient Deathsby Damian GardeSTATJuly 12th, 2016After only two days, the FDA accepted Juno Therapeutics reason for the deaths and allowed the trial to continue.
CAR-T Deaths Cannot Be Goodby Derek LoweScience AAAS July 8th, 2016The deaths will likely move other biotech companies to conduct research with extra caution.
After a deadly clinical trial, will immune therapies for cancer be a bust?by Damian GardeSTATJuly 8th, 2016The deaths were caused by swelling in the brain during the clinical trial.
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