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 know that the United States can save civilization but at least by our example we can make people think and give them the opportunity of saving themselves. The trouble is that the people of Germany, Italy and Japan are not given the privilege of thinking.”
—Franklin D. Roosevelt (1882–1945)
“In an ideal society, mothers and fathers would produce potty- trained, civilized, responsible new citizens while government and corporate leaders would provide a safe, healthy, economically just community.”
—Mary Kay Blakely (20th century)
“Nothing can be more real, or concern us more, than our own sentiments of pleasure and uneasiness; and if these be favourable to virtue and unfavourable to vice, no more can be requisite to the regulation of our conduct and behavior.”
—David Hume (1711–1776)
“I thought it altogether proper that I should take a brief furlough from official duties at Washington to mingle with you here to-day as a comrade, because every President of the United States must realize that the strength of the Government, its defence in war, the army that is to muster under its banner when our Nation is assailed, is to be found here in the masses of our people.”
—Benjamin Harrison (1833–1901)
“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)