The FDA’s oversight plan for the review of LDTs is massively costly, slow and administratively burdensome, and it would force many clinical laboratories to stop or massively scale back providing these critical testing services to their patients—even when there is no commercial alternative. ASCP strongly opposes the FDA rule.
Representative Brad Finstad (R-MS) has introduced legislation—the Freedom for Laboratory Innovation and Testing Act—that would halt FDA’s implementation of the rule. We need Congress to act as soon as possible.
In addition, we are also asking you to let your members of Congress know that the “VALID” Act (Verifying Accurate Leading-edge IVCT Development Act) is NOT an acceptable alternative to the FDA’s rule. The VALID Act suffers from the same problems as the FDA rule, and it too would undermine the ability of clinical laboratories, including those in hospitals and academic medical centers, to provide these services.
How you can help
ASCP is working with other clinical laboratory and pathology organizations that are unified in their concern about the impact FDA oversight could have on the ability of clinical laboratories to care for their patients. Please use ASCP’s e-Advocacy Center to tell Congress to that FDA oversight of LDTs is misguided and should be stopped.