U.S. Federal

In comparison to many other nations, the U.S. has few federal laws specifically addressing human genetic technologies. The Genetic Information Nondiscrimination Act of 2008 (GINA), which prohibits the use of individuals’ genetic information in employment and health insurance, is an exception. Similarly, while many countries have established legislation about aspects of assisted reproduction, the only federal U.S. law is the 1992 Fertility Clinic Success Rate and Certification Act, which requires fertility clinics to report standardized success rate data to the Centers for Disease Control. Unlike dozens of other countries with advanced biotech sectors, the U.S. has no federal laws regulating human reproductive cloning or inheritable genetic modification. However, the FDA has asserted authority over practices including human reproductive cloning, “three-person IVF,” and inheritable genetic modification; the National Institutes of Health makes decisions about research funding; and Congress has exerted some control over research involving human embryos through budget riders.
Biopolitical Times

The direct-to-consumer (DTC) gene testing company 23andMe seems to be in a strange position. The Food and Drug Administration (FDA) is gradually loosening the legal limits it placed on the company’s operation, and the industry as a whole does seem still to be growing.

However, 23andMe, along with other direct-to-consumer gene testing companies, faces at least two other problems: increasing criticism of the value of their tests; and the rapid approach of whole-genome testing, which could make their...

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The Food and Drug Administration’s move to allow 23andMe to screen people for breast cancer risks may unleash a flood of new direct-to-consumer genetic tests.

But some genetic experts and members of the medical community are raising concerns about whether...

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This spring, the National Institutes of Health will start recruiting participants for one of the most ambitious medical projects ever...

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The home page of the Minnesota biotech company Recombinetics shouts “The Gene Editing Revolution Is Here.” 

Or it would be, if only...

Gray scaled image, showing a woman who appears to be falling, with her hair covering her face and in motion.

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A medical expert wearing gloves and a white coat, hold a needle as a patient extends their arm.

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Silhouette of a tractor in a crop field. Against its background is a sunset, and blue skies with clouds

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In a grass field, a brown and white cow stares. On its right ear, there is an identification tag.

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