The FDA has cleared the way for more direct-to-consumer genetic health tests to come to market. If finalized, the approach will allow certain manufacturers to bring genetic tests to market without undergoing premarket review.
FDA Commissioner Scott Gottlieb, M.D., is proposing to grant these freedoms to companies that complete a one-time review. In shifting regulatory attention from individual products and onto the companies that make them, the FDA is following the playbook it created for digital health. Both of the approaches loosen regulatory oversight of precertified companies.
This new way of working marks a change of tack at the FDA. The agency set its current course in 2013 when it hit 23andMe with a warning letter and ordered it to stop providing its DNA analysis service. 23andMe began its regulatory recovery in 2015 by getting FDA clearance to market a test for Bloom syndrome. But that test-by-test regulatory approach acts as a handbrake on the sector.
Gottlieb is now set to release the brakes. And, having set out his stall in digital health and genetic tests, the commissioner is looking for other chances to move the regulatory burden from products to firms.
“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. 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,” Gottlieb said in a statement.
In the case of genetic tests, the FDA thinks the approach will “provide a reasonable assurance of safety and effectiveness” while also increasing access to “beneficial innovative devices.” The FDA is placing requirements (PDF) on providers of genetic tests to increase the likelihood of the benefits outweighing the risks.