As a follow-up to the late breaking news article on September 29, 2023 regarding FDA’s issuance of a proposed rule to regulated laboratory developed test (LDTs), multiple stake holders, such as the American Clinical Laboratories Association (ACLA) and AdvaMed, have publicly revised the call for Congress to pass legislation to grant FDA new authorities to regulate LDTs. This Congressional method was attempted in 2022 via the Verifying Accurate, Leading-edge IVCT Development (VALID) Act effort of 2022, which despite some points of agreement by multiple Congressional participants, Congress failed to make final passage for VALID Act. These revised calls for Congress to pass the VALID Act, or a variant built from it, reflect the effort that went into that from multiple stakeholders, and more specifically, reflects the initial view by stakeholders that VALID Act represents a more desirable method of allowing FDA regulation of LDTs than the recent FDA proposed rule method. It is anticipated that in the near future, more stakeholders will voice their opinions on the desirability of a VALID Act (or variant) passage to enable FDA regulation of LDTs versus the FDA proposed rule method.
This Congressional effort outcome remains to be seen, and while there is currently much disarray in Congress as the House of Representatives is not technically functional to pass any legislation without an elected Speaker of the House, there is hope for this to be resolved sooner than later, with it being more like for a chance of passage of a VALID like Act in 2024.
