Update: FDA Taking Another (Public) Look at DTC Genetic Tests

Direct-to-consumer (DTC) genetic tests are back on the FDA’s public radar screen. A month from today, the agency’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee will meet to “discuss and make recommendations on scientific issues concerning [DTC] genetic tests that make medical claims.” Here is the Federal Register notice (pdf).

The two-day meeting, which is open to the public, will investigate the following topics:

  • The risks and benefits of making clinical genetic tests available for “direct access by a consumer without the involvement of a clinician (i.e., without a prescription).”
  • The different types of DTC or direct access tests (e.g., carrier screening, risk prediction in healthy persons, pharmacogenetics, etc.) that might “support differences in the regulatory approach.”
  • The “level and type of scientific evidence appropriate for supporting [DTC] claims, including whether it should be different than” what is required for similar clinical genetic tests (presumably, non-DTC in vitro tests, including laboratory developed tests, or LDTs).

A complete agenda and list of speakers has yet to be published, but the fact that the FDA is singling out DTC genetic tests for specific attention is sure to be a welcome sign to many.

In the whirlwind of activity this past summer, DTC genetic test providers were haled before both Congress and the FDA to defend their businesses, even as the FDA simultaneously unveiled plans to regulate all LDT tests. The frenetic pace of activity left industry, the public and, seemingly, the FDA with a number of unanswered questions. Chief among them: does the FDA consider DTC genetic tests to be LDTs, or do the unique issues raised by direct consumer access to these relatively new products merit separate regulatory consideration? This confusion was reflected in the FDA’s two-day public meeting on LDT regulation and in the written public comments submitted over the following months, which saw a disproportionately high number focus primarily or exclusively on DTC genetic tests, despite the fact that those tests comprise only a fraction of the tens of thousands of LDTs the FDA is seeking to regulate.

Which is what makes next month’s DTC-only meeting such a good idea. The meeting is a tacit acknowledgement by the FDA that the agency needs to continue to gather data and viewpoints about DTC genetic tests, along with the unique opportunities and challenges they present, separately from its ongoing efforts at LDT regulation. As a recent Nature Biotechnology editorial suggests, it may also mark the start of a shift in the FDA’s attitude toward the regulation of DTC genetic tests, prompted in part by recent direction from President Obama and the White House, to take a closer look at how agency regulations burden small businesses and to demonstrate an “increased flexibility” in reducing those burdens. That’s significant, especially when coupled with the results of a recent study published in the New England Journal of Medicine by researchers from the Scripps Translational Science Institute (pdf). The Scripps study evaluated the responses of over 2,000 DTC genetic test customers (who used Navigenics’ Health Compass product) and found no significant post-test anxiety or other adverse results. While it will take time to assess the full impact of both the Scripps study (which will require, among other things, longitudinal follow-up and independent confirmation) and the Obama Administration’s new regulatory policies, Nature Biotechnology opines that these signs suggest that the FDA’s “stance to the DTC genetics sector has been perhaps too aggressive” thus far. We agree.

Whatever the FDA’s attitude toward DTC genetic tests in the past, the upcoming public meeting is a positive development. By continuing to facilitate public dialogue—the public may submit comments to the agency in writing until February 23 and apply (until February 15) to make an oral presentation at the meeting—the FDA is sending a clear signal that it recognizes it cannot develop an appropriately tailored system of oversight for DTC genetic tests without consulting, directly and repeatedly, the public it seeks to inform and to protect.

One final note on timing. In early January, despite the ongoing legal and regulatory uncertainty and before the Obama Administration unveiled its new business-friendly approach to regulation, we wrote that direct federal regulation of the DTC genetic testing industry in 2011 appeared highly unlikely. As we head into the spring, with the FDA still clearly in information-gathering mode and Washington’s short-term focus on other priorities, including lessening regulatory burdens overall, there is no reason to adjust that prediction. This should come as welcome news for those who have argued that what the DTC genetic industry needs today is greater transparency and better data, not heightened regulation.