Sen. Lamar Alexander (R-TN), who chairs the Senate Health Committee, has issued a response from Washington, D.C., regarding the U.S. Food and Drug Administration’s (FDA) recent decision to postpone guidance on laboratory-developed tests until the new administration takes over.
“I am glad that the FDA has listened and will delay making final its current draft guidance that could have halted more than 60,000 lab-developed tests in their tracks, and will work with Congress and the new administration on next steps,” Alexander said.
Previously, the FDA was considering issuing final policies on lab developed tests, or LDTs, by the end of this calendar year. An LDT is an in vitro diagnostic test that is manufactured by one laboratory and meant for internal diagnostic use, in contrast to diagnostic kits made by medical device firms.
Industry stakeholders and various Republican lawmakers applauded the deferral; large nationwide lab companies such as Laboratory Corporation of America and Quest Diagnostics will gain a certain advantage with the postponement. The FDA first considered regulating LDTs over two years ago, releasing two draft documents in 2014 pertaining to its potential jurisdiction.
“These tests are essential to helping millions of Americans screen for and diagnose diseases and conditions and advancing the president’s Precision Medicine Initiative to find more tailored treatments and cures,” Alexander said. “It is important to get this right.”
FDA spokesperson Tara Goodin concurred, stressing the importance of balancing patient protection with progress.
“We … realize just how important it is that we continue to work with stakeholders, our new administration and Congress to get our approach right,” she said.
