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December 17, 2013

The controversy over the FDA’s recent letter ordering the genetic testing company 23andMe to stop marketing its services for failure to comply with the agency’s regulatory process suggests that the prognosis for direct-to-consumer health services, particularly genetic testing

, is quite uncertain. Given the enormous potential benefits to consumers, this is unfortunate, and policymakers should work to make sure the regulatory environment for the direct-to-consumer market encourages, rather than hampers, innovation. 

Technology is bringing forth a wide range of new products and services that give consumers direct access to information about their health. For too long, access to medical information has been dependent on a patient’s access to a qualified health care provider. The growth in direct-to-consumer medical services promises to disrupt this model, and in the process, greatly increase the quality of consumer health care and reduce medical costs (see the Manhattan Institute video Building a 21st Century FDA). 

Unfortunately, the FDA seems to have concerns about allowing consumers to receive information with possible medical consequences outside of the doctor-patient relationship. As FDA’s director of personalized medicine said “We’re just very concerned about these tests that consumers can buy themselves, and their only interpretation [of the results] may come from a company.” Similar concerns were also expressed prior to the approval of home testing kits for teen drug use and HIV

But just as consumers do not need a doctor to hold their hand as they spit into a test tube, they often do not need a doctor to read them the results of a test, especially when companies are able to provide consumers more informative online guides to explain results. The FDA needs to adapt its regulatory model to recognize that new technology and business models increasingly eliminate intermediaries, including doctors, and consumers have a right to obtain their own medical information outside of the confines of a doctor-patient relationship.

This is not to say that the FDA should have no role in the direct-to-consumer market. As in any other market, regulation is needed. If a company offers consumers a medical test, genetic or otherwise, the FDA should validate the clinical validity of the test, the accuracy of the marketing claims, and the appropriateness of the labeling, to ensure that consumers get what they are promised and that risks are adequately disclosed. 

The FDA’s regulatory approach must be rooted in the fact that perfect information does not exist. The correlations between genetic variations and disease are still being teased out, just as they are for other health markers and medical conditions. The FDA should not make a company that is simply providing links to the latest medical research obtain approval prior to posting a new link or resource for their customers. 

In addition, the FDA’s regulatory approach should be tempered by the specifics of what a company is selling to consumers. Genetic information can be used for multiple purposes, such as ancestry research, and the FDA has no business regulating companies that are not marketing their genetic tests for medical purposes. 

Finally, the FDA should remember that it is not the only agency looking out for consumers. The FTC and state regulators are often aggressive in protecting consumers from false claims. Customers who receive inaccurate results also have well established contract and tort remedies. Companies offering direct-to-consumer tests, and their investors, have a stake in ensuring accuracy since the reputational loss from a series of successful cases could easily erode much of the company’s value even before any verdict is rendered.

While the FDA may feel more comfortable if patients received all of their genetic information through the carefully vetted filter of the medical establishment, direct to consumer genetic testing should not face unreasonable barriers. An expensive test for a narrow range of genetic markers will never make sense for most consumers. 

When evaluating new technology FDA ought to weigh both costs and the benefits. For example, in gathering genetic information from hundreds of thousands of consumers, companies like 23andMe can contribute to the state of knowledge about these relationships. The FDA should also articulate a clear and reasonable hurdle that companies must meet. 

The legitimacy of regulators depends upon their ability to increase social value, and unless policymakers find a way to allow new technology to disrupt medicine, the FDA will certainly fail this test and make consumers worse off. 


Joseph V. Kennedy is a Senior Researcher with the Information Technology and Innovation Foundation, President of Kennedy Research, LLC, and a contributor to e21. Daniel Castro is a Senior Analyst with the Information Technology and Innovation Foundation.

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