California State Actions Point To Need For Federal Leadership On Genetic Testing

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California State Actions Point To Need For Federal Leadership On

Genetic Testing

http://www.medicalnewstoday.com/articles/118236.php

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

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

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. 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