Illustration: Eniola Odetunde/Axios
A federal judge in Texas on Monday threw out a contentious FDA rule to increase federal regulation of diagnostic tests, saying the agency overstepped its authority when it finalized a policy to treat the tests as medical devices.
Why it matters: Congress established a special framework for overseeing lab-developed tests but at no time suggested that FDA could regulate such laboratories, U.S. District Judge Sean Jordan wrote in a 51-page opinion that vacated the rule.
- "Through the final rule, it appears that FDA is attempting to circumvent that legislative decision. It has no authority to do so," Jordan wrote.
The ruling was a win for testing giants Quest Diagnostics and Labcorp as well as for academic medical centers, which frequently make their own lab tests and had argued that the Biden administration rule would squelch innovation and drive up compliance costs by more than $1 billion a year.
- The American Clinical Laboratory Association and Association for Molecular Pathology filed lawsuits to block the rule that were combined in the U.S. District Court for the Eastern District of Texas.
Background: Lab-developed tests are regulated by CMS but haven't been subject to pre-market approvals or controls after they're sold in the U.S.
- After years of debate, the Biden administration last spring finalized a policy to treat the tests as medical devices, citing the risks to patients from potentially flawed or inaccurate tests.
- HHS prevented FDA from regulating the tests during President Trump's first term, and there was speculation that the current administration would take a hands-off approach to enforcement.
Congress has made several unsuccessful attempts at overhauling regulation of diagnostics, including via the VALID Act during the last session.
