Thanks @Mark Arnold for sharing...
Discoveries in Health Policy: Judge Strikes Down FDA LDT Regulation!
On March 31, 2025, federal judge Sean Jordan sided with ACLA and AMP and struck down the FDA's plan to regulate all laboratory-developed tests nationwide.
The President of AMP writes,
- Today, the U.S. District Court ruled in favor of the Association for Molecular Pathology in our lawsuit challenging the FDA's final rule on laboratory-developed testing procedures (LDTs).
- Judge Sean D. Jordan's decision vacates (cancels) the FDA's final rule, which sought to regulate LDTs as medical devices - an overreach that would have significantly increased costs, financially burdened laboratories, stifled innovation and, most critically, restricted patient access to essential tests.
- This ruling reaffirms what we have long advocated: The FDA's attempt to impose these regulations was unlawful. It also underscores the invaluable role of laboratory professionals in developing and delivering high-quality, innovative diagnostics that advance precision medicine.
The two page "judgment" is here:
https://www.amp.org/AMP/assets/File/advocacy/FDA%20Final%20Rule/LDT%20FINAL%20JUDGMENT%20033125.pdf
The full 51-page opinion is here:
https://www.amp.org/AMP/assets/File/advocacy/FDA%20Final%20Rule/LDT_Opinion_3_31_2025.pdf
What next?
The judge delivered a resounding negative opinion from A to Z and also ruled that the regulation was "vacated" (canceled.)
- Will FDA appeal? It's more White House and HHS and DOJ than "FDA." DOJ (for FDA) would need to file an intention to appeal within 60 days. They might file this even if they are considering their options.
- LDT Stakeholders? Will message politicians and public that the case should be viewed as over (thus implying government ought not appeal.
- Watch this: Will government file emergency motions to undo the cancellation of the regulation? So that, FDA enforcement will go forward at great expense at full speed, maybe for years, as if nothing happened - while court battles creep onward. TBD.
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Robert Nelson
Scientific Officer, Senior Director
BioAgilytix Europe GmbH
Hamburg Germany
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer or other entities to which I am affiliated.
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