Alexander Floats Separate Agency For LDT Oversight To Avoid Regulatory Duplication

Senate health committee Chairman Lamar Alexander (R-TN) floated creating a new regulatory agency to oversee lab-developed tests, which he told lawmakers would be preferable to the current duplicative regulation by CMS, FDA and state regulators. He also told reporters he hoped FDA would not release a final version of its controversial draft guidance bringing LDTs under the medical device regulatory scheme, given Senate and House efforts to address the issue. The committee held a hearing Tuesday (Sept. 20) to weigh...