In March earlier this year, 23andMe presented its views on possible federal regulation of the direct-to-consumer (DTC) genetic testing industry at an Advisory Committee meeting convened by the FDA. We reiterated our belief that individuals have a right to access their own genetic information without physician involvement, and suggested components of a regulatory framework that would ensure the high quality of that genetic information while maintaining direct-to-consumer access to personal genetic testing and enabling innovation.
Despite compelling arguments for DTC genetic testing the panel concluded that access to most types of health-related genetic tests should require a physician’s approval. At 23andMe, we encourage individuals to discuss their genetic test results with their health care providers and involve them fully in decision-making about their health. But we also contend that individuals should be allowed direct access to this information. We continue to work with FDA to develop a reasonable path forward.
In the months before and following the meeting, many of you responded to our call and submitted public comments to the FDA supporting as well as arguing against direct-to-consumer genetic testing. More open and honest debate about this issue can only be beneficial for the industry over the long run.
On September 22, 2011, Bay area citizens will have another chance to make their voices heard. FDA’s Center for Devices and Radiological Health (CDRH) will be holding the third of its 2011 public town hall discussions where individuals can present their views directly to senior CDRH officials, including the Center Director, the Deputy Director for Science, and the head of the Office of In Vitro Diagnostics, which regulates DTC genetic testing. The September town hall will be held at the Embassy Suites Hotel near the San Francisco international airport.
For more information about the town hall, see the official FDA announcement. Note that while anyone in attendance can ask questions during the Q&A session, individuals must register and specifically request to speak if they would like to make comments during the public presentation period.
If you have strong opinions on whether individuals should have direct access to their genetic information, we encourage you to continue making your views known to FDA, whether through in-person meetings such as the town hall in September, or through letters and other correspondence. After all, we believe that having more information is a good thing!