As a physician working in Congress to help guide public policies that support American innovation, I see few things more promising than the tremendous strides in the development of personalized medicine.
Thanks to the mapping of the human genome, physicians can now identify disease at the genetic level, where all disease starts. We now have the promise of earlier diagnosis, better-targeted care, fewer adverse events and cost savings from reducing unnecessary or inappropriate treatments.
This technology is already saving and improving lives in patients with leukemia, breast cancer, HIV and heart disease, with the ability to alleviate human suffering that no doctor has ever before known.
The work in this new frontier comes in large part from clinical laboratories. Gene mapping replaces the trial-and-error medicine of past centuries with new precision medicine powered in part by the vigorous and innovative industry of laboratory-developed diagnostics.
The genetic testing and genomic lab industry sector — an American-born-and-bred industry — generates some 116,000 jobs in this country. These are jobs with good pay — an average of $57,000 per year. True to the American spirit of innovation, most of these jobs are from the small, innovative startup labs and companies throughout the United States.
This is just the kind of industry America needs — innovative, growing and creating the technological base that will foster new companies and new industries in the future. We talk a lot about needing to make America more competitive. Industries like this will do it.
But here’s the rub. Labs that provide such innovation are already regulated by the federal government — yet the Food and Drug Administration wants to bring the dynamic innovation of developing genomic and genetic testing under the FDA umbrella.
That’s the same FDA that is already so backlogged that American patients only a few months ago gained access to breakthrough heart valve replacement technologies four years after the Europeans.
As these tests become more detailed, regulations to ensure their basis in sound science and their validity are reasonable. Yet the smart approach is to update the regulatory structure already in place — which is what I’ve done in the Modernizing Laboratory Test Standards for Patients Act.
This bill would update the existing regulatory architecture. It continues to rely on the Centers for Medicare and Medicaid Services as the bedrock for regulating labs. It ensures that the CMS evaluates lab-developed tests for validity but does not add FDA duplication that would only slow down access to tests doctors and patients need.
This legislation represents a careful balance.
By building on current safeguards within the CMS, we can assure that laboratories provide accurate and reliable testing services.
For both new and existing tests, under my legislation, the CMS can review the data supporting clinical validity, and if not acceptable, request more information or make a final decision that the tests pose an immediate risk to health. The CMS can also instruct the lab to cease offering the test and impose appropriate legal sanctions to protect the public.
The CMS is already familiar with the oversight of the clinical laboratory industry. As a result, a clear command structure overseeing safety and effectiveness of new tests will encourage investment in innovative advanced diagnostics.