- The Food and Drug Administration and Centers for Medicare and Medicaid Services defended a proposed rule to increase oversight of laboratory-developed tests (LDTs) in the face of heavy opposition.
- In a joint letter posted Thursday, leaders from the two agencies made the case for strengthening the FDA’s regulation of LDTs and outlined why they are opposed to expanding the Clinical Laboratory Improvement Amendments (CLIA), the program through which the CMS oversees laboratory testing, to address concerns with the diagnostics.
- Last month, the White House said it expects the FDA to finalize the rule on LDTs in April, but the level of opposition, plus the potential for legal challenges if the proposal goes ahead, has led to questions about whether the changes will come into force.
Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, and Dora Hughes, acting chief medical officer and acting director of the Center for Clinical Standards and Quality for the CMS, set out the argument for increasing oversight of LDTs in the joint letter.
Quoting the Centers for Disease Control and Prevention, the leaders say that “roughly 70% of healthcare decisions depend on laboratory test results.” The FDA developed its approach to LDTs “half a century ago when tests made and used in single labs were generally simple, often made to address local individual needs and mostly manufactured in small volumes.”
Those factors led the FDA to generally opt against enforcing requirements for LDTs. However, LDTs have changed since the agency established its policy, according to Shuren and Hughes, and the FDA is aware of LDTs that have led to patients receiving inappropriate treatment and incorrect diagnoses.
The FDA’s response, as set out in the proposed rule, is to bring LDTs “under the same enforcement approach as other tests.”
The CMS supports the plan, according to the letter. Shuren and Hughes wrote that the proposed rule “would better assure the safety and effectiveness of LDTs and would remove a disincentive for non-laboratory manufacturers to develop novel tests.”
Laboratory trade groups, providers and other groups have argued against the plan, with some claiming the increased oversight would limit patients’ access to tests and hurt innovation. Some people have suggested expanding CLIA to address concerns about LDTs, though the FDA and CMS leaders are opposed to that solution.
“CMS does not have the expertise to assure that tests work; the FDA does,” Shuren and Hughes wrote. “Moreover, establishing a duplicative system for the oversight of tests by expanding CLIA would create more government bureaucracy and inconsistencies. That makes no sense.”
Groups including AdvamedDx have said an act of Congress is needed to support the planned changes to the regulation of LDTs. However, Congress has failed to pass the VALID Act, legislation that would bring in-vitro diagnostic tests and LDTs under one risk-based framework. It is also unclear when there will be another chance for lawmakers to act, as TD Cowen analyst Eric Assaraf recently explained in an email to MedTech Dive.
“There will be less opportunities to get a bill done as we get closer to the elections, so it might have to wait until the lame duck [session] or 2025,” wrote Assaraf.