ACLA Retains Attorneys Paul D. Clement and Laurence H. Tribe To Represent ACLA in Opposing the FDA’s Proposal To Treat Laboratory Developed Tests (LDTs) as Medical Devices

The American Clinical Laboratory Association (ACLA) announced that it has retained former Solicitor General Paul D. Clement, a partner with Bancroft PLLC, and Laurence H. Tribe, the Carl. M. Loeb University Professor and Professor of Constitutional Law at Harvard University, and a distinguished scholar working with Massey & Gail LLP, for representation on matters relating to the Food and Drug Administration’s (FDA) recently issued draft guidance to regulate laboratory developed tests (LDTs) as medical devices. The FDA’s draft guidance is a regulatory overreach that could adversely affect thousands of clinical laboratories and tens of thousands of tests, and access to tests for millions of patients. Most advances in the field of personalized medicine with regard to diagnostics are the result of innovation in laboratory developed testing. Under the proposed guidance, these and future testing services developed in clinical laboratories will be subject to duplicative federal regulation and a high degree of regulatory uncertainty. “ACLA’s decision to hire Messrs. Clement and Tribe, and their decision to take this case, should be seen as an indication of the strength of our conviction that the merits favor protecting patients, labs, and physicians from this unjustified regulatory action.”