The FDA brought out its final rule about regulating lab developed tests in May. Within a month, ACLA had filed a lawsuit. By late summer, AMP had filed its own lawsuit. (Both lawsuits were in Texas jurisdictions and have been combined now.)
The week of October 6, two new items.
CAP files a friend-of-court (amicus) brief supporting ACLA/AMP. (21pp).
ADLM (former AACC) files an amicus brief supporting ACLA/AMP, too. (25pp). Joined by ASCP, ASM, IDSA, and others.
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Other arguments, not emphasized here, are there that is a great deal of overlap among specific rules and regulations used by both CLIA and CAP (see the CLSI's excellent guide to the new DFA device regulations "for labs," which exists in part to show the overlaps and variances between CLIA and "FDA-LDT." Plus it's currently free.)
See an article by van Wijk and McMillin in J Appl Lab Med, 4 October, on the FDA final rule and pharmacogenomics (hint: bad). Here. (Not open access).
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AI Corner (Chag GPT 4o)
The College of American Pathologists (CAP) argues that the FDA’s Final Rule on laboratory-developed tests (LDTs) is arbitrary and capricious, asserting that the agency failed to justify the immense compliance costs imposed, which will hinder innovation and harm patients. CAP contends that the FDA’s reliance on nonbinding “enforcement discretion policies” fails to provide the stability needed for LDT development and that these policies introduce uncertainty and prosecution risks that will chill innovation. CAP urges the court to vacate the rule on these grounds and avoid addressing broader statutory authority questions. If the court does address FDA's authority, CAP suggests limiting the ruling to avoid unintended consequences for LDT regulation, including avoiding characterizing LDTs as “the practice of medicine” and implying that existing CLIA oversight renders FDA involvement unnecessary.
The Association for Diagnostics & Laboratory Medicine (ADLM) and other allied organizations argue that FDA’s Final Rule will drastically limit access to LDTs, essential for prompt and effective patient care, especially in underserved communities. They claim that LDTs, developed under CLIA, offer necessary flexibility and rapid response capabilities that FDA’s device-based regulatory framework would undermine. The brief emphasizes that the rule's immense costs, potentially reaching billions, would force labs, particularly smaller and specialized ones, to shut down, leading to delays and reduced access to critical diagnostic services. ADLM and co-amici assert that the FDA's enforcement discretion is inadequate and arbitrary, risking severe patient harm, and urge the court to vacate the rule as exceeding the FDA’s statutory authority.
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Comment (BQ). "CAP urges the court to vacate the rule on these grounds and avoid addressing broader statutory authority questions". CAP urges that the simplest and complete reason to vacate the regulation is that it was arbitrary and capricious. They note that if so, the court will not need to consider statutory grounds (what is the original meaning of "device" as used by Congress in 1976) or constitutional grounds (e.g. "major questions doctrine.") There is a longstanding principal to make a finding on one aspect of the case, and leaving other topics unnecessary to decide, as they are not 'reached.' A similar principal is, if a plaintiff has a constitutional objection, and he/she is found to lack "standing" to bring the case, the court drops the case, and has no need to ask the constitutional question "as if" the plaintiff had had standing.
