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:
“I do not look upon these United States as a finished product. We are still in the making.”
—Franklin D. Roosevelt (1882–1954)
“In our governments the real power lies in the majority of the community, and the invasion of private rights is chiefly to be apprehended, not from the acts of government contrary to the sense of the constituents, but from the acts in which government is the mere instrument of the majority.”
—James Madison (1751–1836)
“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)
“Yesterday, December 7, 1941Ma date that will live in infamy—the United States of America was suddenly and deliberately attacked by naval and air forces of the Empire of Japan.”
—Franklin D. Roosevelt (1882–1945)
“The line that I am urging as today’s conventional wisdom is not a denial of consciousness. It is often called, with more reason, a repudiation of mind. It is indeed a repudiation of mind as a second substance, over and above body. It can be described less harshly as an identification of mind with some of the faculties, states, and activities of the body. Mental states and events are a special subclass of the states and events of the human or animal body.”
—Willard Van Orman Quine (b. 1908)