In Don’t Let the FDA Regulate Lab Tests! and The New FDA and the Regulation of Laboratory Developed Tests I warned that the FDA’s power grab over laboratory developed tests was both unlawful and likely to result in deadly harm (as it did during COVID). Thus, I am pleased that a Federal judge has vacated the FDA’s rule entirely, writing:
…the text, structure, and history of the FDCA and CLIA make clear that FDA lacks the authority to regulate laboratory-developed test services.
…FDA’s asserted jurisdiction over laboratory-developed test services as “devices” under the FDCA defies bedrock principles of statutory interpretation, common sense, and longstanding industry practice.
The judge also noted some of the costs that I had pointed to:
…the Fifth Circuit has made clear that district courts should generally “nullify and revoke” illegal agency action, Braidwood, 104 F.4th at 951. The Court finds that such relief is appropriate here. The final rule will initially impact nearly 80,000 existing tests offered by almost 1,200 laboratories, and it will also affect about 10,013 new tests offered every year going forward. The estimated compliance costs for laboratories across the country will total well over $1 billion per year, and over the next two decades, FDA projects that total costs associated with the rule will range from $12.57 billion to $78.99 billion. FDA acknowledges that the enormous increased costs to laboratories may cause price increases and reduce the amount of revenue a laboratory can invest in creating and modifying tests.
… For these reasons, it is ORDERED that the Laboratory Plaintiffs’ Motions for Summary Judgment, (Dkt. #20, #27), are GRANTED. The final rule is hereby SET ASIDE and VACATED.
HHS head RFK Jr. should immediately instruct the FDA to halt any further efforts to regulate laboratory developed tests.
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