FDA Opens Door to Direct-to-Consumer Marketing of Genetic Tests—But Just a Crack

In a notice for public comment issued last November, the FDA raised eyebrows by floating a proposal that would make it easier to bring new genetic health risk (GHR) assessment tests to market. The message to GHR test manufacturers: Once you get first time premarketing authorization, you can sell new GHR tests directly to consumers (DTC) without undergoing additional review. On June 5, the agency made good on its promise by finalizing the proposal.

The New DTC Genetic Tests Exemption
The June 5 notice, (which also says that not even premarket notification is necessary for certain class II (moderate risk) GHR assessment devices) is the latest example of the FDA’s new “flexible” regulatory approach to genetic risk tests. “As consumer interest in genetic risk information grows, opportunities are also expanding for the detection of additional genetic conditions and diseases that can help inform people of their medical risks,” according to the statement.

While acknowledging that these tests pose risks “especially if they provide consumers with incorrect or misleading information that may be used to make health choices without the advice of a medical professional,” the agency insisted that one-time premarket authorization would be enough to manage the problems of false negatives and false positives. And, of course, test manufacturers would still be on the hook for making false claims in their DTC advertising.

Doesn’t Apply to GHR Tests Used for Treatment Decisions
The notice also makes it clear that the new exemption does not apply to GHR tests used to inform treatment decisions. The four types of tests that cannot be commercialized even with prior premarket approval include:

1. Prenatal testing;

2. Cancer predisposition testing;

3. Pharmacogenomics testing; and

4. Genetic diagnosis of deterministic autosomal dominant variants.

The not-for-treatment-decision limitations are consistent with previous FDA policy. Thus, for example, earlier this year, when the FDA granted first ever premarket authorization to 10 GHR tests from consumer genomics firm 23andMe, it attached strings in the form of “caveats” or controls restricting DTC marketing of GHR tests used to inform treatment decisions, such as hereditary cancer tests analyzing BRCA1 and BRCA2 genetic mutations that may influence women to decide whether to have a prophylactic mastectomy.


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