Point/Counterpoint: On FDA Regulation of DTC Genetic Tests

March 10th, 2011
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Medscape.com reporter Emma Hitt wrote yesterday, “A U.S. Food and Drug Administration advisory committee has agreed that direct-to-consumer (DTC) clinical genetic tests should have more oversight from the U.S. Food and Drug Administration (FDA).”
The recommendation came after the FDA’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee met for two days in Washington, DC. The Panel discussed several issues – from potential risks of incorrect results for DTC testing performed without medical counseling to claims associated with various DTC genetic tests.
We’ve long been interested in this subject area and we followed some of the live coverage of the panel via Twitter posts from the likes of @RDGene @aliciaault @likesky3 @genomicslawyer and @dgmacarthur using the hashtag #FDADTC. Subsequently, we read perspectives surrounding the Panel’s deliberations via blog posts by @dnalawyer and @dgmacarthur, which you may want to check out.

Here, Ken Walz and I offer our own point/counterpoint take on a letter the American Medical Association wrote to the FDA Panel in which the Association called for strict regulation of DTC testing.
The AMA wrote in its letter: “The AMA has consistently supported efforts to realize the full potential of personalized medicine and the great promise it offers to the delivery of individualized care that meets the particular needs of each patient. However, we have concerns that the unfettered and unregulated growth of genetic tests marketed directly to consumers will have a significant adverse impact on consumers and undermine the physician-patient relationship. In many cases, it also represents the unauthorized practice of medicine.”
Caroline PopperCAROLINE: We need to balance access to information with adequate background on how to use the information. The data resulting from DTC testing is often difficult to interpret even by trained professionals, let alone by a consumer. However, increased demand for and access to information is an unstoppable trend. The FDA should establish processes to regulate the analytical performance of DTC tests. Meanwhile, professional medical organizations should engage in (and take some responsibility for) consumer education.
Ken WalzKEN: The AMA is painting with a very broad brush as it characterizes DTC genetics companies and how those companies do (or do not) inform consumers. The AMA view seems to be that consumers/patients cannot be expected to make informed use of the results of these tests. However, any visitor to the 23andMe site cannot help but notice the extensive disclaimers imploring customers to seek qualified medical advice before acting on their results. These disclaimers seem more than sufficient.
The idea that we need to protect consumers/patients from knowledge of their genome is a paternalistic attitude that is out of sync with the rapid advances in technology that enable that knowledge. The physician/patient relationship that the AMA says it seeks to protect will only be undermined to the extent that physicians are less knowledgeable than their patients – a situation that can be prevented by the physician becoming and staying knowledgeable about new medical technologies.
In its letter to FDA, the AMA wrote that it is necessary for DTC genetic testing to “be carried out under the personal supervision of a qualified health care professional” and that “individuals interested in obtaining genetic testing access” should be steered “to qualified health care professionals for further information.”
Caroline PopperCAROLINE: I don’t think a qualified professional should always be a mandatory component for execution of a DTC genetic test. Rather, manufacturers and testing companies need to try and provide information, however complex and nuanced, in a manner that the consumer can use. This doesn’t need to be all that different than when a consumer buys a new laptop.  He or she doesn’t need to be a technology expert, but should be able to absorb basic information and to consult with a technician when certain offerings require advanced levels of knowledge. Furthermore, when it comes to DTC genetic testing, it is only in the last year or two that physicians-in-training have begun to truly be taught about how to interpret these tests…so existing generations of physicians may not know more than the average consumer.
Ken WalzKEN: I don’t think these tests need to be carried out under medical supervision. As for directing interested consumers/patients to a qualified health care professional for more information, while this shouldn’t be a requirement, many DTC testing companies will make this suggestion to consumers/patients as the market develops and matures. We may even see some of the DTC companies offer this as part of their service.
The AMA wrote, “We encourage this [FDA] Panel to make a recommendation that the FDA work with the U.S. Federal Trade Commission to require that DTC companies include all relevant information regarding capabilities and limitations of the tests directly to consumers who utilize their services as well as on their websites and in other literature advertising the tests.”
Caroline PopperCAROLINE: I agree with this statement. It’s appropriate for a regulatory agency to ensure that good information is available in a manner that is most easily digested by consumers.

Ken WalzKEN: I think that there should be regulatory oversight, but only to the extent necessary to ensure that the tests are run properly and the results are accurate. Note that this only pertains to the test itself not to the clinical interpretation of the test results. I would be in favor of a requirement that companies demonstrate technical competence and disclose proof of this competence in their marketing materials.
In closing, here are our respective thoughts on how DTC genetic tests should be used, by whom, and where they can make a difference in health care.
Caroline PopperCAROLINE: They should be available to and accessed by everyone, as desired, except for insurance companies.

Ken WalzKEN: DTC tests should be used by anyone interested in gaining greater awareness of his or her personal genetic characteristics for any reason. Obviously the information should remain private and not permitted to be used against an individual in any context.
The biggest impact of DTC tests at the moment is in the area of prevention and wellness as better-informed individuals may make healthier choices and decisions with respect to diet, exercise, and lifestyle than they would have in the absence of knowing their genetic characteristics and predispositions.
There’s obviously quite a lot of room for debate around the issue of DTC genetic testing and the potential for FDA regulation of how these tests are given and interpreted. Please add your thoughts below and share with us your take on these issues.

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About the Author:

I founded Popper and Company with Ken Walz more than ten years ago to address inefficiencies in health care by helping life science companies develop and commercialize new technology. Today, the members of our growing team leverage their extensive knowledge of the tools and trends shaping all aspects of health care and its participants. Send me an email.

4 Responses to “Point/Counterpoint: On FDA Regulation of DTC Genetic Tests”

  1. shirley grose says:

    Concise and interesting. Just posted some of your comment on 23&me community forum.

  2. Peter Rogan says:

    The issue is not whether these tests should be offered under medical supervision, but whether the consumers (and their physicians) can appreciate the uncertainty inherent in these results. Most reveal genetic associations and attempt to compute risk based on these associations. Everyone has a different perception and tolerance for risk, and when the risks (increase or decrease) are modest, patients may make or be advised to make changes in their lifestyle that may not be justifiable.

    • Ken Walz Ken says:

      I think you’ve touched on the central issue – should individuals be shielded from knowledge of their genetic information? Thanks for reading.