FDA Delays Guidelines on Regulating Lab-developed Tests
FDA is delaying guidelines for regulating laboratory-developed tests until after the Trump Administration takes office in January. Earlier this year, Congressional Republicans (see story) balked at the agency’s plans to finalize guidelines, warning it not to overreach since a draft guidance was released in 2014. House Energy and Commerce subcommittee chair Michael C. Burgess (R-TX) said he agreed with FDA’s decision not to move forward with the guidance. “21st Century medicine should not rely on trial-and-error, and unnecessary burdensome regulation of laboratory tests could send us back to the dark ages,” he said. “As our country seeks to harness the value of precision medicine, we must not obstruct access to tools that enable clinicians to target treatment based on the personal profile of each individual patient. I am confident that the House Committee on Energy and Commerce will continue to engage with patients, providers, clinical labs, researchers, and the rest of the medical community to ensure federal policies allow diagnostic innovation to advance the state of health care for all Americans.”
In the Senate, Sen. Lamar Alexander (R-TN) has said that FDA’s proposal would amount to “double regulation” since the tests are already regulated by the Centers for Medicare and Medicaid Services through the Clinical Laboratories Improvement Act. At a Senate Health Committee hearing on the proposal, Alexander said “the biggest loser, it seems to me, would be Americans who stand to benefit from the rapid pace of science and discovery.” He cited an example from Vanderbilt University, which he said performs 105 “medical tests designed, manufactured, and used in a single laboratory.” Making even one of those tests subject to FDA approval, he said, could cost Vanderbilt $30 to $75 million to go through the process. “You can see how quickly costs could add up, even into the billions,” Alexander added.
An FDA spokesperson said the agency has been working to develop a new oversight policy for tests, “one that balances patient protection with continued access and innovation, and realize just how important it is that we continue to work with stakeholders, our new Administration, and Congress to get our approach right. We plan to outline our view of an appropriate risk-based approach in the near future. It is our hope that such an approach will help guide continued discussions.”