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:
“God knows that any man who would seek the presidency of the United States is a fool for his pains. The burden is all but intolerable, and the things that I have to do are just as much as the human spirit can carry.”
—Woodrow Wilson (1856–1924)
“No more distressing moment can ever face a British government than that which requires it to come to a hard, fast and specific decision.”
—Barbara Tuchman (1912–1989)
“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)
“In the United States, it is now possible for a person eighteen years of age, female as well as male, to graduate from high school, college, or university without ever having cared for, or even held, a baby; without ever having comforted or assisted another human being who really needed help. . . . No society can long sustain itself unless its members have learned the sensitivities, motivations, and skills involved in assisting and caring for other human beings.”
—Urie Bronfenbrenner (b. 1917)
“I asked myself, “Is it going to prevent me from getting out of here? Is there a risk of death attached to it? Is it permanently disabling? Is it permanently disfiguring? Lastly, is it excruciating?” If it doesn’t fit one of those five categories, then it isn’t important.”
—Rhonda Cornum, United States Army Major. As quoted in Newsweek magazine, “Perspectives” page (July 13, 1992)