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:
“An inquiry about the attitude towards the release of so-called political prisoners. I should be very sorry to see the United States holding anyone in confinement on account of any opinion that that person might hold. It is a fundamental tenet of our institutions that people have a right to believe what they want to believe and hold such opinions as they want to hold without having to answer to anyone for their private opinion.”
—Calvin Coolidge (1872–1933)
“This morning the British Ambassador in Berlin handed the German Government a final Note stating that, unless we heard from them by 11 o’clock that they were prepared at once to withdraw their troops from Poland, a state of war would exist between us. I have to tell you now that no such undertaking has been received, and that consequently this country is at war with Germany.”
—Neville Chamberlain (1869–1940)
“Nothing changes my twenty-six years in the military. I continue to love it and everything it stands for and everything I was able to accomplish in it. To put up a wall against the military because of one regulation would be doing the same thing that the regulation does in terms of negating people.”
—Margarethe Cammermeyer (b. 1942)
“The United States must be neutral in fact as well as in name.... We must be impartial in thought as well as in action ... a nation that neither sits in judgment upon others nor is disturbed in her own counsels and which keeps herself fit and free to do what is honest and disinterested and truly serviceable for the peace of the world.”
—Woodrow Wilson (1856–1924)
“An ... important antidote to American democracy is American gerontocracy. The positions of eminence and authority in Congress are allotted in accordance with length of service, regardless of quality. Superficial observers have long criticized the United States for making a fetish of youth. This is unfair. Uniquely among modern organs of public and private administration, its national legislature rewards senility.”
—John Kenneth Galbraith (b. 1908)