FDA Considers Regulation of DTC Gene Tests, Setting Blogs Ablaze

Posted by Jillian Theil on March 17th, 2011

Last week, an FDA advisory panel met to discuss and make recommendations on “scientific issues concerning direct to consumer (DTC) genetic tests that make medical claims.” The Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee ultimately decided that genetic testing by companies like 23andMe and Navigenics should not be offered without a doctor’s supervision. The FDA is currently considering how best to regulate DTC genetic tests, but exactly how they will do so is still unclear.  

While mainstream media has devoted little coverage to the meeting, blogs and Twitter networks that follow the controversies around direct-to-consumer gene testing have been set ablaze in the aftermath of the panel’s recommendations.  Over at Genetic Future, which is generally enthusiastic about DTC gene testing, Daniel MacArthur writes:

My overall impression from reports on the panel discussion, though, is somewhat ominous: both Dan (Vorhaus) and Alicia (Ault) noted an apparent consensus among the panel members that genetic results should be returned via a physician. As I argued last month, this is an obsolete, paternalistic vision for genomic medicine that flies in the face of primary physicians’ self-admitted ignorance of genetics, and will become simply untenable as we enter the era of cheap whole-genome sequencing.
Other posts on the blogosphere here, here, and here echo this mentality.  From a different perspective, Mike the Mad Biologist, while generally in favor of DTC, argues the following:
But the DTC industry made a huge and—arrogant—mistake by not listening and not preemptively dealing with legitimate public health concerns….[T]he DTC testing industry never really took these claims seriously–and never investigated with large enough sample sizes across a range of educational backgrounds—to assuage these concerns.
He also suggests that the arguments for greater oversight to protect consumers should not be dismissed, and points to medical authorities' experiences with patients who do things that are not so good for their health (think vaccine rejection).

In his testimony at the FDA hearing, Jeremy Gruber of the Council for Responsible Genetics made the argument for consumer protection and the need for responsible regulation:
… There are significant concerns that we have for the industry as a whole, as it currently operates without regulation. .. We believe everyone should have access to their genome and be able to sequence it if they choose. What we do feel strongly about, however, is that people shouldn't be misled about the significance of that information and that people should be able to be assured that the claims that are made are accurate and that their privacy will be protected. We must acknowledge that information can cause both direct and indirect harms as well as good.
While much of the discourse on DTC genetic testing and regulation has been thought-provoking and well-informed, some supporters of unsupervised genetic testing erred on the side of excessive zeal when they cast doubt on the veracity of last July’s GAO report, which revealed significant problems in the industry. The criticisms of the GAO's lead investigator, leveled by an advisor to DTC companies, have been found to be erroneous.

Meanwhile, DTC companies 23andMe and Pathway Genomics are reportedly saying that they wish to comply with whatever regulatory structure is developed by the FDA. But they are not yet ready to give up their current business model which provides consumers their results directly, without supervision of a doctor.

Previously on Biopolitical Times:

Posted in Biotech & Pharma, Civil Society, Media Coverage, Personal genomics


Comments are now closed for this item.

  1. Comment by Jillian Theil, Apr 13th, 2011 1:43pm

    Hi Justin,

    Thanks for reading and taking the time to comment!

    It it important to point out that there are questions raised by such products that go beyond test accuracy. One of the major issues is consumer privacy. Is genetic information submitted by consumers secure? Does the company own the data submitted by consumers? Can they disclose this information to a third party? How can we ensure that consumer's privacy rights are protected?

    These are only a few of the many questions that we should think about in regard to DTC tests and regulation.


  2. Comment by Justin Smith, Mar 31st, 2011 9:31pm

    I think that this is really a setback for the progress of personalized medicine. One shouldn't require a prescription to get a genetic test done. The tests are generally quite accurate in their calling of the DNA SNPs. The area where they must improve is simply in their analysis of what the results mean, but that is true for the field of Genetics as a whole.

    As a customer of both 23andMe and Lumigenix I feel it is both exciting and potentially useful to have this information. For example, I took a medicine a few years ago to which I had some bad side effects. With 23andMe I could have known that that medicine is unlikely to be effective. Someday I hope my doctor will have and know how to use this data, but I don't feel I should be required to go to my doctor to have access to genetic data.

    However, it would be nice if 23andMe had some sort of tutorial to make sure people really know some of the disclaimers regarding their genetic data. The Genome Wide Association Studies from which they base their health risks may not really give a fully accurate prediction at this time. I think people should know that from the onset. It is nice how they seem to constantly update their site with new information, and do research studies of their own to discover new trait/SNP associations.



home | overview | blog | publications | about us | donate | newsletter | press room | privacy policy

CGS • 1120 University Ave, Suite 100, Berkeley, CA 94702 USA • • (p) 1.510.625.0819 • (F) 1.510.665.8760