In the ongoing federal court case, ACLA & AMP vs FDA on lab-developed tests, today reached an oral hearing before a Texas-based judge.
The audio is not available, but I assume that at some point today's transcript will be appear in the docket at PACER (a court archive). The judge in the Texas Eastern District is Sean Jordan.
Meanwhile, at Endpoints News (free w/ email), Nicole DeFeudis summarizes the afternoon:
https://endpts.com/government-is-set-to-address-its-lab-developed-test-rule-in-court/
And Shannon Bennett summarizes at Linked In:
https://www.linkedin.com/feed/update/urn:li:activity:7298346983667208192/
And see Christine Bump's summary at Linked In:
https://www.linkedin.com/pulse/aclas-amps-suits-over-ldt-final-rule-summary-judgement-bump-h3nyc/
Positions Were Predictable
The positions were predictable, but at least before the last week or two, it wasn't certain what position the incoming Trump administration would take. There's been at least one case (regarding transgender law) where the Trump federal attorneys quickly took a position 180 degrees opposite that of earlier Biden federal attorneys.
And, back to the LDT case, CAP has officially asked the DJT administration to evolve the position of the FDA and its attorneys and develop a new schema via lawmaking. (CAP page here.)
- For FDA and HHS, DOJ attorney Gabriel Schonfeld restated his position that, "The final rule is both within the FDA statutory authority, and not arbitrary or capricious." (Quoting from Endpoints).
- For ACLA/AMP, Michael Schumsky, Hyman Phelps McNamara, for the plaintiffs, argued that the FDA's position is "as unreasonable as calling a surgical procedure 'a device.' " (Quoting from Endpoints).
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What will happen?
Back on December 25, I fed the final legal arguments into Chat GPT and it predicted the FDA would lose, a blog that was picked up by an article in Dark Report.
And I've always felt (as a policy-watcher but non-attorney) that the ACLA-AMP arguments seemed fairly sound. For example, doesn't it seem odd that CLIA would have rules and guidance allowing LDTs (or LDT variations of IVDs), yet at the same time, the same test results were illegal (not FDA)?
I could add a few more comments:
- Today's DOJ Not Tomorrow's DOJ. While the DOJ defended the 2024 position of the FDA today, if it gets a "stinging take-down" in the judge's opinion, in March or April, it may reconsider whether to fight on. Toss-up, but an extra shot on goal for ACLA.
- Lobbying continues. As mentioned, various organizations like CAP are urging the WH, HHS, FDA, to take a different approach, a process that will continue. Favors ACLA.
- Judge may lean toward agreeing with DJT position, because it is the DJT position.
- I've seen that a lot of conservative judges are all-too-happy to accuse federal agencies of going too far in their regulations. Favors ACLA.
- But - let's balance that - by the possibility a federal judge may see a cleaner promotion pathway (such as to federal appeals court) by reasonably supporting positions of the newly Republican DOJ wherever he can, rather than building a record of disagreeing with them if he doesn't feel he has to. Favors FDA.
Shannon Bennett notes in his Linked In article, the FDA offered that if plaintiffs prevail, there are intermediate possible stops other than simply vacating the rule. That could lead to a complicated time-course.
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AI CORNER
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Summary of the FDA LDT Oral Hearing (ACLA/AMP v. FDA) – February 20, 2025
The oral arguments in the ACLA/AMP lawsuit against the FDA’s LDT Final Rule took place in Plano, Texas, presided over by Judge Sean D. Jordan. The hearing lasted over three hours, with both sides presenting arguments on whether laboratory-developed tests (LDTs) should be regulated as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA).
Key Issues and Judge’s Focus Areas
1. Defining LDTs: Are They Devices?
- ACLA & AMP’s Argument: LDTs are a professional service, not a physical product, and therefore do not meet the FDCA’s definition of a "device". They emphasized that LDTs are developed and performed within a single laboratory and are not manufactured for sale in interstate commerce.
- FDA’s Argument: LDTs are a subset of in vitro diagnostic (IVD) test systems, which are already regulated as medical devices. The agency argued that LDTs are "test systems" that include physical components (e.g., reagents, instruments) and could be packaged and sold as kits—but laboratories choose to offer them as a service instead of selling them.
📌 Judge’s Reaction: He asked both sides to clarify whether LDTs are a "physical thing" introduced into interstate commerce and pressed FDA on whether its definition of "device" includes all LDTs.
2. Statutory Interpretation of FDCA & CLIA
- ACLA & AMP: Congress has never explicitly given FDA authority over LDTs, and the legislative history (FDCA 1938, Medical Device Amendments 1976, CLIA 1988) suggests LDTs were always meant to be regulated under CLIA, not FDA.
- FDA: The FDCA’s definition of "device" includes terms like "contrivance" and "article," which cover LDTs. FDA claims its authority has existed since 1938, even if it exercised enforcement discretion until now.
📌 Judge’s Reaction: He pushed both sides on whether Congress’s intent was to exclude LDTs from FDA oversight and asked for clarification on how the CLIA framework differs from FDA’s regulatory authority.
3. Impact on Public Health and Costs
- ACLA & AMP: Enforcing FDA regulations on LDTs will cost billions of dollars, significantly reduce access to rare disease testing, and force labs to shut down tests. The plaintiffs cited $115 billion in initial costs and $14.5 billion annually.
- FDA: The Final Rule balances patient safety and innovation, ensuring that all tests meet proper regulatory standards.
📌 Judge’s Reaction: He acknowledged concerns about economic impact and patient access, but he also noted that FDA claims authority over LDTs regardless of financial burdens.
4. Dueling Surgical Analogies
- ACLA & AMP: Compared LDTs to surgeons using different tools during a procedure—just because they combine devices, they don’t become a device manufacturer.
- FDA: Countered with the example of a defective heart stent—even if a surgeon implants it, the stent remains a regulated medical device.
📌 Judge’s Reaction: He pushed both sides on these examples and seemed to find merit in both analogies, though it’s unclear which argument he favored.
5. Remedy If Plaintiffs Win
- ACLA & AMP: If the court rules against FDA, the entire rule should be vacated.
- FDA: The court does not have to fully vacate the rule—it could apply only to specific tests or manufacturers.
📌 Judge’s Reaction: He asked both sides about potential partial vs. full vacatur, indicating he is weighing a more limited ruling.
Final Takeaways
- Judge Jordan demonstrated strong knowledge of the case and asked pointed questions on statutory interpretation, public health impact, and analogies.
- The ruling could come soon, as the judge acknowledged the May 6, 2025, Phase 1 deadline under the FDA’s phaseout policy.
- The case will likely hinge on how SCOTUS interprets “device” under the FDCA and whether Congress clearly delegated regulatory authority over LDTs to FDA.
This hearing highlights the ongoing legal battle over LDTs, with huge implications for laboratories, diagnostics, and regulatory precedent.
