|ACLA president Alan Mertz|
Alan Mertz, president of the American Clinical Laboratory Association (ACLA), ripped into the FDA's proposal to regulate lab-developed tests yesterday in a testimony to Congress during a hearing of the 21st Century Cures initiative.
"ACLA and the FDA fundamentally disagree on several key issues, including their statutory authority to regulate LDTs and the promulgation of new regulatory oversight through guidance documents," he said. "And ACLA has other concerns related to the framework as outlined in the Congressional notification document."
He insisted that the FDA does not have the authority to regulate LDTs under the the Food, Drug and Cosmetics Act (FDCA). "LDTs are proprietary procedures for performing a diagnostic test using reagents and laboratory equipment. They are essentially know-how, not physical articles. Therefore, they are not subject to regulation under the FDCA," he said.
But Jeffrey Shuren, head of FDA's devices arm, was equally adamant in his testimony at the hearing that the tests are devices and fall under the purview of the FDA saying, "FDA has had the authority to regulate LDTs as devices since Congress amended the device definition to include all in vitro diagnostics in the Medical Device Amendments of 1976."
Going beyond the ability of the FDA to regulate LDTs in principal, which appears well established at least in practice, Mertz took aim at the proposal itself, saying it raises many unanswered questions.
Supporters of the FDA proposal, including the trade association AdvaMed, say it eliminates the two-track system whereby laboratories are regulated under CLIA and manufacturers of test kits by the FDA. But Mertz said that it would be unreasonable to claim there is a level playing field "when manufacturers and laboratories run fundamentally different operations."
Mertz questioned how the two systems would coexist: "There is no discussion of how any additional regulation by the FDA would interact with the regulation already in place under the CLIA (Clinical Laboratory Improvement Amendments) program, including those functions performed by deemed authorities. There are many areas of commonality and overlap, and yet there is no discussion of how two separate regulatory authorities would regulate the laboratory industry in a way that would not impede innovation."
"Defining exactly what the device is that the FDA seeks to regulate, or where the manufacture of the test ends and the performance of the test begins, has yet to be explained," he continued.
He also questioned whether the FDA has the resources to deal with the increased workflow, saying, "We also have very real concerns about resource constraints within the Agency to effectively manage this entirely new area of diagnostic regulation. There are tens of thousands of LDTs in existence today, with hundreds of new tests created every year."
Testifying in support of the proposal was AdvaMed's Andrew Fish as well as Shuren, whose testimony was largely a summary of the proposal and its justifications, as explained upon the proposal release to Congress in July.
A draft guidance codifying the proposal is expected soon. Much of its details were laid out in the mandated notification to Congress issued July 31.
- read the witness' testimony