FDA Commissioner Scott Gottlieb on Monday announced that FDA plans to adopt a new approach for regulating direct-to-consumer genetic health risk tests that would exempt such products from premarket reviews under certain conditions.
Direct-to-consumer genetic health risk tests allow people to test their own genetic risk for various diseases. While the tests can be useful to help inform people's health care decisions, they also run the risk of giving users inaccurate or misleading information, among other concerns.
Details on notice of intent
In a statement, Gottlieb said FDA had issued a notice of its intent to allow manufacturers of direct-to-consumer genetic tests to undergo a "one-time review" to ensure the company meets FDA's requirements.
Gottlieb said FDA in a separate de novo classification order established special controls for such tests—including requirements for determining accuracy, reliability, and clinical relevance of such tests. The order also describes the studies and data required to demonstrate the performance of certain genetic health risk tests. If approved, the manufacturer would be able to release new tests without receiving FDA approval.
Gottlieb said the approach is similar to a precertification path that FDA proposed for digital health technologies earlier this year.
The notice does not apply to ancestry or lifestyle tests or to so-called diagnostic genetic tests, such as those that test for the BRCA1 and BRCA2 genes that could increase a woman's risk of developing cancer.
Bradley Merrill Thompson, an attorney with Epstein Becker Green and an expert on FDA regulation of digital technologies, said, "We will really have to wait and see what the real world experience is with this new program, but frankly I'm tickled that FDA is trying to think so creatively." Thompson said, "We really do need fresh thinking, and the agency is clearly willing to consider ideas well outside the traditional box."
Timothy Mackey, an associate professor at University of California-San Diego School of Medicine and an expert in health policy and law, said FDA's move does not come as a surprise, considering that earlier this year FDA stepped back from its prior concerns with 23andMe, which provides genetic health risk tests. Mackey said this move "simply confirms [the] approach [FDA took with 23andMe] for other [genetic health risk] manufacturers and … details the special controls they must follow in order to access this pathway subject to certain exemptions."
Mackey added that the move "does reduce regulatory burden, but I think it needs to be monitored closely as digital apps and [direct-to-consumer genetic health risk tests] present different benefits vs. risk and should not be conflated" (Preston, MedCity News, 11/7; Kim Cohen, Becker's Hospital Review, 11/7; Comstock, MobiHealthNews, 11/7; FDA release, 11/6).
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