DeGette, Bucshon Release Statement on Burdensome FDA Rule Regulating Lab-Developed Tests

WASHINGTON D.C. — Today, Congresswoman Diana DeGette (CO-01) and Congressman Larry Bucshon, M.D. (IN-08) released the following statement after the Food and Drug Administration (FDA) finalized a rule regulating lab-developed tests (LDTs), a subset of in-vitro clinical tests (IVCTs).

“Rational oversight of in-vitro diagnostics, including laboratory-developed tests, is vital for innovation in diagnostics and public health. We are disappointed that the FDA has moved ahead with a burdensome rule based on an inflexible statute that was never designed to regulate in vitro diagnostics. However, we also recognize that FDA’s action today is because Congress hasn’t acted yet. Congress has not given FDA the tools it needs to appropriately carry out its public health mission. With innovative test makers, medical centers, and labs that are the backbone of diagnostics in the U.S. now facing this burdensome regulation, we must come together and pass our VALID Act. The tiered, risk-based approach to in-vitro test oversight we have developed would protect patients and spur diagnostic innovation. We can create a rational oversight system for in-vitro tests, and we owe it to the patients of today and tomorrow to get this right.”

Americans rely every day on IVCTs to diagnose a disease or condition. These tests use human samples, such as blood or tissue to gain insight into the best path for patient care. Innovation in the diagnostic field is occurring at a rapid pace and holds great promise in improving health care for Americans. While diagnostic tests are a critical piece of the ability to make health care decisions, burdensome regulation of these medical products creates uncertainty in the future of innovation and patient care.

The VALID Act would establish a comprehensive framework for oversight of IVCTs, including tests that would currently go through FDA review as a medical device and the LDTs that are impacted by today’s rule. Under this framework, FDA would apply a tiered, risk-based oversight structure to the design of all diagnostic tests. The VALID Act avoids duplication with CLIA and would require FDA to prioritize the tests that present the highest risk to patients while encouraging innovation and promoting patient safety for all categories of IVCTs.

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