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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.



Human Chimera Research’s Huge (and Thorny) Potentialby Paul KnoepflerWiredSeptember 19th, 2016Stem cell researcher notes a range of ethical questions on the table if the NIH moves forward with lifting its research ban.
US toughens rules for clinical-trial transparencyby Sara ReardonNature NewsSeptember 16th, 2016Under new HHS rule, researchers must register information on the design and results of trials within 21 days of enrolling their first patient-- regardless of outcome.
Presidential Candidates on Scienceby Pete ShanksBiopolitical TimesSeptember 16th, 2016Hillary Clinton, Donald Trump and Jill Stein answer 20 questions about science policy.
DNA Dragnet: In Some Cities, Police Go From Stop-and-Frisk to Stop-and-Spitby Lauren KirchnerProPublicaSeptember 12th, 2016Private police databases expanding with DNA “voluntarily” collected from minors, without oversight or right to challenge.
5 Reasons Why We Need People with Disabilities in the CRISPR Debatesby Emily Beitiks, Biopolitical Times guest contributorSeptember 8th, 2016“Why do I have to keep justifying my existence?” How gene editing policy discussions reproduce ableist assumptions and generate advocacy fatigue.
FDA Warns Against Widely Used Ovarian Cancer Screening Testby Sheila KaplanSTATSeptember 7th, 2016Despite extensive annual use, the tumor biomarker test has not proven to be reliable nor effective.
Sperm Donor at Heart of Canadian Lawsuits Admits He Lied to Company Xytex, Police Sayby Diana MehtaThe Canadian PressAugust 30th, 2016Amidst pending lawsuits, Sperm Donor 9623 has turned himself in to the police for "falsifying paperwork."
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
The Little-Known History of the Forced Sterilization of Native American Womenhttp://daily.jstor.org/the-little-known-history-of-the-forced-sterilization-of-native-american-women/August 25th, 2016Both the IHS and its dark history of forced sterilization were the result of longstanding, often ham-fisted attempts to "address" American Indians’ health care needs.
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."
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