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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.



As Kuwait imposes world’s first DNA collection law, attorney tries to fight itby Cyrus FarivarARS TechnicaSeptember 22nd, 2016“Compelling every citizen, resident, and visitor to submit a DNA sample to the government is similar to forcing house searches without a warrant."
Titanic Clash Over CRISPR Patents Turns Uglyby Heidi LedfordNature September 21st, 2016Parties aggressively wage a billion-dollar patent battle meanwhile licensing their disputed rights to large drug companies aiming for clinical trials.
Stem Cell Advocates and Critics Push Back on FDA Guidelinesby Alexandra OssolaScientific AmericanSeptember 21st, 2016At a public hearing on how strictly therapies should be regulated, testimony noted the number of unscrupulous clinics preying on desperate patients with unsubstantiated claims.
Patients Turn To San Diego Stem Cell Companies For Costly, Unproven Treatmentsby David WagnerKPBSSeptember 20th, 2016An investigation reveals a US stem cell company is referring patients to Mexico for non-FDA approved therapies that may be causing harm.
White House science advisers urge Justice Dept., judges to raise forensic standardsby Spencer S. HsuWashington PostSeptember 20th, 2016A new report cautions that widely used methods to trace complex DNA samples to criminal defendants fall short of scientific standards.
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.
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