Genomics Law Report ®
News and analysis from the intersection of genomics, personalized medicine and the law
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).
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.