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:
“... the yearly expenses of the existing religious system ... exceed in these United States twenty millions of dollars. Twenty millions! For teaching what? Things unseen and causes unknown!... Twenty millions would more than suffice to make us wise; and alas! do they not more than suffice to make us foolish?”
—Frances Wright (1795–1852)
“During the first formative centuries of its existence, Christianity was separated from and indeed antagonistic to the state, with which it only later became involved. From the lifetime of its founder, Islam was the state, and the identity of religion and government is indelibly stamped on the memories and awareness of the faithful from their own sacred writings, history, and experience.”
—Bernard Lewis, U.S. Middle Eastern specialist. Islam and the West, ch. 8, Oxford University Press (1993)
“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)
“Some time ago a publisher told me that there are four kinds of books that seldom, if ever, lose money in the United States—first, murder stories; secondly, novels in which the heroine is forcibly overcome by the hero; thirdly, volumes on spiritualism, occultism and other such claptrap, and fourthly, books on Lincoln.”
—H.L. (Henry Lewis)
“The moment a mere numerical superiority by either states or voters in this country proceeds to ignore the needs and desires of the minority, and for their own selfish purpose or advancement, hamper or oppress that minority, or debar them in any way from equal privileges and equal rights—that moment will mark the failure of our constitutional system.”
—Franklin D. Roosevelt (1882–1945)