Future of FDA’s LDT Rule Uncertain with Latest Supreme Court Decision
In overturning the Chevron case, justices diminish the power of federal agencies like the FDA
Scott Wallask, BA, is senior editorial manager for Today’s Clinical Lab and G2 Intelligence. He has spent more than 25 years covering the healthcare and high-tech industries. A former newspaper reporter, he graduated from Northeastern University with a degree in journalism.
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A U.S. Supreme Court decision published on June 28 may eventually turn out to be good news for clinical labs opposed to the new U.S. Food and Drug Administration (FDA) regulations for laboratory-developed tests (LDTs).
In a 6–3 decision, the Supreme Court overturned so-called Chevron deference for regulators as part of the case Loper Bright Enterprises et al. v. Raimondo, Secretary of Commerce, et al. In broad stokes, the decision will limit how much federal agencies can interpret vague parts of laws passed by Congress.
“Chevron determined that courts should defer to the expertise of federal regulatory agencies if there is ambiguity in interpreting a particular statute,” Shannon Bennett, director of regulatory affairs for the Department of Laboratory Medicine and Pathology at Mayo Clinic, wrote on LinkedIn.
With the overturn of the Chevron deference, “I suspect many such agency interpretations will now be subject to greater scrutiny by the courts in the event of a lawsuit,” added Bennett. He recently explained the state of LDT regulation during a free webinar for Today’s Clinical Lab and G2 Intelligence called, “Key Things Labs Need to Know about the FDA’s Final LDTs Rule.”
In arguing the case before the Supreme Court, the federal government argued that Congress relies on subject matter experts at agencies to resolve ambiguities in laws.
An LDT lawsuit against FDA is already in progress
The American Clinical Laboratory Association (ACLA) has already filed suit against the FDA over the new LDT rule. The ACLA lawsuit mentions Chevron deference, which stems from a 1980s case called Chevron U.S.A. Inc. v. Natural Resources Defense Council.
The Supreme Court’s decision essentially decreases the power of federal agencies. It is not hard to imagine the ACLA using the decision to argue against the FDA’s stance that LDTs are medical devices that require agency review, as opposed to medical services. Other clinical lab trade groups, including the Association for Diagnostic and Laboratory Medicine, also oppose the FDA’s rule on similar grounds.
The court decision may also give more fuel to the idea that Congress should reexamine the Verifying Accurate and Leading-Edge IVCT Development (VALID) Act. That bill, which would regulate LDTs but not to the extent of the FDA’s rule, has stalled for years in Congress. Many labs also opposed the VALID Act, particularly academic medical center labs, although now labs may view the proposed act as less intrusive than the FDA’s final rule.
Published on May 6, 2024, the FDA’s final rule regulates LDTs as medical devices, similar to in vitro diagnostics. The rule allows some exemptions for LDTs, including grandfathering LDTs from FDA premarket submission and records requirements if those tests were created prior to May 6, 2024.
The rule also sets five transition phases through 2028 for labs as they move toward FDA review of LDTs. Check out our timeline of LDT regulation, including a look at the future phases.