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 the united states, united states, government, regulation, united and/or states:
“To be President of the United States, sir, is to act as advocate for a blind, venomous, and ungrateful client; still, one must make the best of the case, for the purposes of Providence.”
—John Updike (b. 1932)
“So here they are, the dog-faced soldiers, the regulars, the fifty-cents-a-day professionals riding the outposts of the nation, from Fort Reno to Fort Apache, from Sheridan to Stark. They were all the same. Men in dirty-shirt blue and only a cold page in the history books to mark their passing. But wherever they rode and whatever they fought for, that place became the United States.”
—Frank S. Nugent (1908–1965)
“In the long-run every Government is the exact symbol of its People, with their wisdom and unwisdom; we have to say, Like People like Government.”
—Thomas Carlyle (1795–1881)
“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)
“... when we shall have our amendment to the Constitution of the United States, everyone will think it was always so, just exactly as many young people believe that all the privileges, all the freedom, all the enjoyments which woman now possesses were always hers. They have no idea of how every single inch of ground that she stands upon to-day has been gained by the hard work of some little handful of women of the past.”
—Susan B. Anthony (1820–1906)
“In the case of a deliberate, palpable, and dangerous exercise of ... powers not granted by the compact, the States ... are in duty bound to interpose for arresting the progress of the evil, and for maintaining within their respective limits the authorities, rights, and liberties appertaining to them.”
—James Madison (1751–1836)