On June 9 California sent letters to 13 genetic-testing companies ordering them to “cease and desist performing genetic testing without licensure or physician order.” Some of the companies have since stopped offering direct-to-consumer tests to Californians, while others insist that they are already in compliance with the law and continue to operate in the state. New York State similarly warned companies this spring that they need licenses to accept DNA samples from the state’s residents. (The Center summarizes the companies’ responses here.)
GPPC has long advocated for comprehensive federal oversight of genetic testing, and disparate state laws and state enforcement actions are clearly consequences of the void at the federal level. The confusion will only grow if and when more states attempt to fill the role the federal government has shirked – a situation that will benefit no one. As California Department of Public Health official Karen Nickel said in a conference call with members of the Clinical Laboratories Advisory Committee, “We’re looking for some kind of federal action.” Similarly, DNATraits founding partner Bennett Greenspan told GenomeWeb Daily News, “I’d rather there be a federal solution than a state solution, just as a matter of efficiency.” For 50 states to each create and enforce their own potentially disparate regulations for genetic tests, and for companies to comply with them, would indeed create massive inefficiencies. State resources would be diverted from other programs, and innovation in the genetic testing industry could be stifled as labs struggle to discern and comply with variable state laws and regulations.
Several companies recently announced plans to team up to devise guidelines for the genetic-testing industry. These standards will tap into considerable scientific and technical expertise, and potentially will be flexible and readily updated as the science progresses. However, they will be voluntary, leaving bad actors free to continue offering deceptively-marketed, inaccurate, or unhelpful tests. Furthermore, having genetic testing companies devise the guidelines creates a potential conflict of interest and may not bolster consumer confidence.
At the same June roundtable where the guidelines plan was announced, a representative from the Federal Trade Commission (FTC) acknowledged that the FTC has the authority to prohibit direct-to-consumer genetic-testing companies from making misleading claims, and said the agency is investigating two such companies. Meantime, some companies are still making the kinds of patently deceptive claims that in 2006 led Sen. Smith to label their products “snake oil.”
We’ve said it before, and we’ll say it again: the most sensible, effective way to ensure the reliability of genetic tests is for the federal government to create and enforce stronger regulations for genetic tests and the laboratories that perform them. – Kathy Hudson, director, Genetics & Public Policy Center
Factsheet – Summary of New York and California Correspondence with Health-Related
Direct-to-Consumer Genetic Testing Businesses
Issue brief – Direct-to-consumer genetic testing: empowering or endangering the public?
Chart – Direct-to-consumer genetic testing companies
Article – Advisory committee recommends improvements to genetic testing oversight