FDA Watch: Agency to Allow DTC Marketing of Genetic Tests without Premarket Approval

The FDA’s longstanding policy of restricting direct-to-consumer (DTC) marketing of products without formal premarket approval is well known. But while it always applied to lab tests, the policy initially crafted for pharma and devices didn’t become a big factor for in vitro diagnostics until 2013 when the FDA issued a warning letter to 23andMe over the marketing of its DNA analysis services. Since then, other consumer genomics firms have received similar warning letters about DTC marketing of genetic tests without premarket approval.

FDA Proposes Marketing without Premarket Approval
But 2017 has witnessed a thaw. The FDA signalled the new approach earlier in the year when it settled with 23andMe. Under the settlement, the agency not only issued premarket authorization of 10 genetic health risk (GHR) tests from 23andMe; more significantly, it gave the greenlight for future DTC launches of other tests without premarket review provided that the firm followed specifically listed controls.

On Nov. 6, the FDA proposed extending the 23andMe treatment to the entire industry. According to the agency’s notice for public comment, premarket authorization is not necessary for certain class II (moderate risk) devices, including vitamin D mass spectrometry-based test systems and GHR assessment test systems.

The catch: GHR test manufacturers will need first time FDA marketing authorization; after that, though, they will be allowed to commercialize new GHR tests without additional review.

The limitation: The new approach doesn’t apply to diagnostic genetic tests that inform treatment decisions, e.g., hereditary cancer tests analyzing BRCA1 and BRCA2 genes to decide if a woman should have a prophylactic mastectomy.

Takeaway: When and if the FDA finalizes the proposal, test makers will have to implement the same controls the FDA ordered 23andMe to use as part of the settlement, including:

  • Labeling outlining test limitations;
  • Information about how the test works and its accuracy vis-à-vis a comparative baseline;
  • References to applicable clinical guidelines and disease risks; and
  • Information on obtaining a genetic counselor.

The New FDA CLIA Waiver Policy

The proposed new DTC policy was hardly the end of the FDA’s new largesse toward in vitro diagnostic product development. On Nov. 29, the agency issued draft guidance proposing to reduce the burden of applying for CLIA waivers allowing for the performance tests involving “insignificant risk of an erroneous result” without CLIA certification. The draft guidance is actually two proposals in one:

The first proposal would make it easier for test makers to demonstrate the accuracy of a test for purposes of securing the “insignificant risk” waiver; and

The second proposal would establish a dual submission pathway enabling test makers to use the same sets of studies to secure Section 510(k) approval and a CLIA waiver, effectively killing 2 FDA regulatory birds with one stone.


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