Government Regulation in The United States
Currently, the U.S. has no strong Federal regulation moderating the DTC market. Though there are several hundred tests available, only a handful are approved by the Food and Drug Administration (FDA); these are sold as at-home test kits, and are therefore considered "medical devices" over which the FDA may assert jurisdiction. Other types of DTC tests require customers to mail in DNA samples for testing; it is difficult for the FDA to exercise jurisdiction over these types of tests, because the actual testing is completed in the laboratories of providers. As of 2007, the FDA had not yet officially substantiated with scientific evidence the claimed accuracy of the majority of direct-to-consumer genetic tests.
With regard to genetic testing and information in general, legislation in the United States called the Genetic Information Nondiscrimination Act prohibits group health plans and health insurers from denying coverage to a healthy individual or charging that person higher premiums based solely on a genetic predisposition to developing a disease in the future. The legislation also bars employers from using individuals’ genetic information when making hiring, firing, job placement, or promotion decisions. The legislation, the first of its kind in the U.S., was passed by the United States Senate on April 24, 2008, on a vote of 95-0, and was signed into law by President George W. Bush on May 21, 2008. It went into effect on November 21, 2009.
Read more about this topic: Genetic Testing
Famous quotes containing the words united states, government, regulation, united and/or states:
“Today’s difference between Russia and the United States is that in Russia everybody takes everybody else for a spy, and in the United States everybody takes everybody else for a criminal.”
—Friedrich Dürrenmatt (1921–1990)
“Nations do not think, they only feel. They get their feelings at second hand through their temperaments, not their brains. A nation can be brought—by force of circumstances, not argument—to reconcile itself to any kind of government or religion that can be devised; in time it will fit itself to the required conditions; later it will prefer them and will fiercely fight for them.”
—Mark Twain [Samuel Langhorne Clemens] (1835–1910)
“Lots of white people think black people are stupid. They are stupid themselves for thinking so, but regulation will not make them smarter.”
—Stephen Carter (b. 1954)
“Then the American flag was saluted. In general, in the United States people always salute the American flag.”
—Friedrich Dürrenmatt (1921–1990)
“The corporate grip on opinion in the United States is one of the wonders of the Western World. No First World country has ever managed to eliminate so entirely from its media all objectivity—much less dissent.”
—Gore Vidal (b. 1925)