FDA Challenge Raises Questions on Right to Genetic Information

Tuesday, November 26, 2013

DNA molecule display (Christian Guthier/flickr)

The genetic-analysis company 23andMe has garnered a devoted following since its launch in 2006. For $99 and a cheek swab, the company analyzes a customer's genetic information for potential disease markers and for genealogical roots, revealing a wide range of genetic information.

Now the Food and Drug Administration (FDA) has ordered the Google-backed company to halt sales of its signature product, the Saliva Collection Kit and Personal Genome Service.

In a letter to the company's founder, Anne Wojcicki, the FDA wrote that 23andMe sold their main product without "marketing clearance or approval." The company released this statement in response.

Nita Farahany, professor of law, genomics and policy at Duke University, took the 23andMe test. She and her now-husband shared their respective profiles on their third date, and she argues that the FDA is overreaching in their regulation of the company.


Nita Farahany

Produced by:

Jillian Weinberger


T.J. Raphael

Comments [3]

RT from Santa Clara

Professor Farahany here is rather more dismissive than she was earlier today on KQED's Forum program, of the concern raised that FDA may have a duty to intercede if 23andMe either has been offering medical advice, making medical claims or had not responded in a timely manner to requests for response made by FDA. This program doesn't mention that 23andMe hadn't responded to the FDA's requests for six months.

In the Forum program, Farahany was clear that *she* felt competent to distinguish between any analytical claims made by 23andMe in *her* results and so was skeptical that inaccuracies or overreach in 23andMe's report could be of much consequence. When Ken Iverson, the host, noted that not every customer of 23andMe and similar services could be expected to have Farahany's education and experience, she allowed that such people might be vulnerable to mis-direction.

In this program, Farahany complains that the source of any "philosophical" dispute with 23andMe's operations is due to

"...what we call health exceptionalists, they believe that if there's any sort of health information or health data that people just can't handle receiving that information directly, that they can't understand what it means, that they aren't qualified to receive the kind of probabilistic information that a company like 23andMe is providing."

This is deliberately disingenuous. I don't understand the immediate dispute or business between the FDA and 23andMe, but it doesn't take more than average amount of prudence to be concerned if a service that's qualified to do no more than report the result of a test may be providing or seeming to provide medical advice.

Nov. 26 2013 03:57 PM
Carol Douglass from San Francisco

Just listened to the apologia for 23andMe. I'm disappointed that Prof. Farahany dismissed--no, she didn't even mention it--the very important issue of what is happening when people get results that say, for instance, that they do not have the gene for a certain type of breast cancer, and stop getting mammograms, thinking they are safe. Or any other kind of medical decision that people make based on a probability-based result from 23andMe. I agree with the FDA that giving out such information without any evidence of the accuracy of the results--which is what the FDA seems concerned about--is irresponsible, and an attempt to make money off of a popular fad. Apparently 23andMe has not provided evidence that their information is indeed accurate. As difficult as the FDA may seem in approving drugs, they are also there to protect the public from misleading and inaccurate medical information. Go ahead and get your DNA but keep in mind that that information may be inaccurate and not safe to make medical decisions on.

Nov. 26 2013 03:43 PM
Will Frehley

There are two issues here. One is the individual's right to know their genetic information, specifically their unique gene variants. The second is the right to make medical claims on those gene variants.

The FDA is confusing the two, so let me be clear. The FDA cannot take away an individual's right to personal genetic knowledge. And no government agency has the ability, much less the right, to regulate scientific claims (proposed by individuals, universities, companies, etc) on each of the 20,000 human genes (and millions of variants thereof).

This usurpation of individual rights is government paternalism and tyranny at its worst. Why not allow anyone to make claims on genetic function, and allow individuals to choose. We can handle it.

Nov. 26 2013 02:20 PM

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