JAMA – A hotly contested proposal by the US Food and Drug Administration to regulate laboratory developed tests (LDTs)—diagnostic tests created and used in-house by hundreds of physicians’ offices, hospitals, and research institutions nationwide—has drawn strong opposition from Sen Lamar Alexander (R, Tennessee), chairman of the Senate Committee on Health, Education, Labor and Pensions (HELP).
In his opening statement at a HELP hearing, Alexander said FDA oversight of such in vitro tests, used exclusively by the laboratories that design them, would be time consuming and exorbitantly expensive, costing as much as $30 million to $75 million apiece to bring each test to market through the FDA process. He argued that this would amount to wasteful “double regulation” because the tests are already regulated by the Centers for Medicare & Medicaid Services program CLIA, or the Clinical Laboratory Improvement Amendments.
“Lab-developed tests have enabled much of the progress already made in cancer research and treatment because they allow physicians to practice at the speed of science rather than the speed of the FDA,” he said, noting, “The biggest loser, it seems to me, would be Americans who stand to benefit from the rapid pace of science and discovery.”
The FDA argues that such tests are “devices,” which fall under its purview, and that intervention is justified because of the increasing risk and complexity of LDTs and “reports of patient harm,” including false-positive and false-negative test results. Oversight is to be phased in over 9 years, the agency says.