Alexander Floats Separate Agency For LDT Oversight To Avoid Regulatory Duplication

September 20, 2016 at 5:11 PM
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 He also told reporters he hoped FDA would not release a final version of its controversial draft guidance bringing LDTs under the medical device regulatory scheme, given Senate and House efforts to address the issue.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...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.