FDA Commissioner Scott Gottlieb announced new rules today regarding direct-to-consumer genetic health risk (GHR) tests and the process by which they're approved for sale. In a statement, Gottlieb explained that these sorts of tests can provide more and more information as the technology develops, information that is not only in demand but could also serve as a useful medical tool. "These tests can prompt consumers to be more engaged in pursuing the benefits of healthy lifestyle choices and more aware of their health risks," said Gottlieb. "Consumers are increasingly embracing genetic health risk testing to better understand their individual risk for developing diseases."
The challenge for the FDA is ensuring the safety and accuracy of GHR tests while also making sure it's promoting and spurring innovation. "The agency has been increasingly nimble and creative in adapting its regulatory framework to fit the challenges of new technology platforms. In its consideration of GHR tests, the FDA seeks to strike a balance that provides for an efficient pathway to bring these tests to consumers, without sacrificing the assurances offered by FDA oversight," said Gottlieb.
To do that, the FDA will now exempt GHR tests from premarket review as long as companies that are selling them meet certain requirements. From now on, manufacturers will have to present themselves to the FDA for a one-time review and if the agency finds that their practices are satisfactory and meet all of the necessary safety and reliability standards, they'll be allowed to sell new GHR tests without any additional reviews. Until recently, consumers had to go to a physician in order to get the results of a genetic health risk test. The agency only began allowing popular at-home test-maker 23andMe to tell customers about certain health risks this April.
Along with these new regulations, the FDA has also laid out exactly what requirements will have to be met in order for manufacturers to pass their review, which include accuracy and reliability assessments. Additionally, the FDA also issued a final order exempting genetic carrier screening tests from premarket review.
These changes follow an announcement made by the FDA in June expressing the agency's intent to begin considering a company's history of testing and maintenance of their low-risk products -- such as health apps -- rather than each individual product developed by the company. All of these efforts are meant to get new, useful products on the market quickly and efficiently while still ensuring their safety and relevance. "We'll continue to look for opportunities to use this type of firm-based regulatory approach, both for new tests and other novel medical products," said Gottlieb. "Our goal is to streamline the regulatory pathway to get innovative medical products to people more efficiently, while providing the FDA assurances that consumers seek."