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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.



Want to enroll in a clinical trial? NIH database is huge ó but lacks a few key detailsby Emily BazarThe Washington PostJuly 26th, 2016Trial sponsors are not required to disclose that patients have to pay to participate.
Uncle Sam Wants You ó Or at Least Your Genetic and Lifestyle Informationby Robert PearThe New York TimesJuly 23rd, 2016The Precision Medicine Initiative will seek participants from various geographies and socioeconomic statuses across the country.
Chinese scientists to pioneer first human CRISPR trialby David CyranoskiNature NewsJuly 21st, 2016Gene-editing technique to treat lung cancer is due to be tested in people in August.
Nudging patients into clinical trialsby Bradley J. FikesThe San Diego Union-TribuneJuly 20th, 2016Incentives include money and rewards such as iPads.
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 (Pro); Marcy Darnovsky (Con)National GeographicJuly 15th, 2016Harris: "Research on Gene Editing in Humans Must Continue"
Darnovsky: "Do Not Open the Door to Editing Genes in Future Humans"
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.
No One Should Edit The Genes Of Embryos To Make Babies, NIH Chief Says[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 about both the safety and social consequences of altering reproductive cells.
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