With only a simple saliva sample, genetic health risk (GHR) testing can inform people about their genetic risk for conditions including Alzheimer’s disease or celiac disease. However, the potential benefits from this testing have been curtailed due to regulatory barriers erected by the Food and Drug Administration. Now FDA Commissioner Scott Gottlieb has announced that the agency would relax some of the restrictions surrounding GHR testing. The new framework would balance risks associated with testing with the burdens of regulation and the need to foster innovation.
The policy established under the Obama administration of prohibiting tests that had not gone through premarket review reflected growing concern among regulators about the risks associated with GHR tests. For example, people could receive a test result indicating that they do not have a genetic variant increasing risk for a condition when they actually do. Working with incorrect information, they might then choose to forego dietary changes, or waive recommendations for more daily exercise, that would have reduced this risk.
Consumers could also misinterpret the information companies provide to them in the reports. While the agency should incorporate potential risks into the regulatory framework for GHR testing, a freeze on health prediction reporting went too far. The earlier actions by the FDA constrained the development of new products.
The rules outlined in the recent announcement would expand upon the agency’s more recent strategy of approving tests for specific diseases or conditions in a piecemeal fashion. The FDA approved a GHR test for a gene variant related to Bloom Syndrome, a rare inherited disorder, back in 2015. In April 2017 the agency authorized tests for 10 diseases or conditions from 23andMe. Even with these steps, the company was still limited in what it could test for and report to customers.
Before the 2013 freeze, the firm had been offering assessments for more than 250 diseases or conditions. The April decision dealt primarily with 23andMe, announcing the agency’s intent to grant that company exemption from premarket review for further tests. The FDA agency did indicate it would consider granting other firms a similar exemption.
Under the new framework, genetic-testing companies would be able to go to the agency for a one-time review. If the firm met the requirements, it would then be allowed to market new GHR tests without having to go through premarket review for each new product. The FDA also establishes specific criteria, called special controls, with requirements related to the tests’ accuracy, reliability and clinical relevance, that additional tests would have to meet.
Aware of the risks of opacity and the room for misinterpretation, the agency cites user studies showing that customers found the reports “easy to follow and understand.” The FDA also has put regulations in place requiring the reports sent to consumers to explicitly state the limitations of the information provided by the genetic risk testing, and to stress that GHR testing should not be used as the basis for a diagnosis.
The potential benefits of these endeavors are not restricted to individuals who would know more about their genetic risks for certain diseases and conditions. People can use this information in their discussions with doctors, or to help them get pursue healthier lifestyle choices. As Peter Huber and Paul Howard have noted, some of these companies are partnering with other organizations to harness the data collected to help identify additional risk factors for certain diseases or conditions. These efforts could further our understanding of these ailments, potentially helping with detection or treatment design down the line.
In his announcement, Commissioner Gottlieb notes the agency’s pilot program for digital health products. The new GHR test policy reflects the agency’s broader commitment to creating an adaptable, flexible regulatory environment. By shifting from a product-based to a firm-based lens, the FDA can ensure that a firm meets their requirements about testing methodologies and dissemination of information, but will not require it to come back for premarket review each time.
The benefits that GHR testing could eventually deliver are not yet fully understood, and overly-restrictive regulation might have prevented the benefits from ever being realized. In this new, more flexible regulatory framework, the agency can better balance the associated risks with considerations of the regulatory burdens that would threaten to slow the development of new products or innovations.
Charles Hughes is a policy analyst at the Manhattan Institute. Follow him on Twitter @CharlesHHughes.
Interested in real economic insights? Want to stay ahead of the competition? Each weekday morning, E21 delivers a short email that includes E21 exclusive commentaries and the latest market news and updates from Washington. Sign up for the E21 Morning Ebrief.