"The government wouldn't allow a company to sell a genetic test unless it worked, right?" Not necessarily, writes Gail Javitt, Director of Law and Policy at the Genetics and Public Policy Center, in the July 2006 issue of the journal Fertility and Sterility.
Despite media reports revealing significant problems with a controversial test to determine fetal sex, and recommendations from several federal task forces about the need to develop safe and effective regulations for genetic testing, the traditional federal regulatory bodies fail to offer adequate assurance that direct-to-consumer genetic tests are safe, accurate, or pertinent to health-care decision making.
Beyond the ethical implications of tests for fetal gender, Javitt argues that the uncertainty regarding the accuracy and clinical validity of the test "should have set off warning bells among federal regulators."
While the company that produces the test claims that the FDA cannot regulate the product because it is not used for medical diagnosis, Javitt asserts that there are justifiable legal foundations for the government to oversee fetal gender tests, but that the government's lack of action on fetal gender tests is part of a broader failure to regulate genetic testing generally.
"Lax oversight of genetic testing is not new, nor has it gone unnoticed," the paper notes, stating that government officials have discussed the need for improved oversight of genetic testing for more than a decade.
Javitt asks, "How many Baby Gender Mentors—and the associated anxiety, unwarranted medical procedures, and potential adverse consequences—will it take to provoke action on genetic testing?" The current regulatory framework creates an environment that may result in a loss of public trust in the ability of DNA research to improve health, she warns, and it may tarnish the reputation of good genetic testing actors through association with bad actors. Without better regulation, the promise of genetic testing to produce "personalized medicine" may not be fully realized, she adds.
Javitt G. "Pink or Blue? The Need for Genetic Test Regulation Is Black and White." Fertility and Sterility (2006) 86 (1): 13-15.
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