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 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.
- 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.
- See a second blog with discussion of these in's and out's - here.
The March 31, 2025 decision by Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas is a watershed ruling in the battle over FDA’s authority to regulate Laboratory-Developed Tests (LDTs). In ACLA et al. v. FDA and AMP et al. v. FDA, the court struck down the FDA's 2024 Final Rule that sought to classify and regulate all LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). This 51-page opinion—accompanied by a 2-page final judgment—delivers a forceful rebuke to FDA’s regulatory overreach and represents a resounding victory for the laboratory plaintiffs.
⚖️ Key Holdings:
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FDA's Final Rule is Vacated in Full
The Court vacated and set aside the FDA's final rule in its entirety: Medical Devices; Laboratory Developed Tests, 89 Fed. Reg. 37,286 (May 6, 2024). -
FDA Lacks Statutory Authority under the FDCA
The court held that LDTs are not “devices” under the FDCA and thus fall outside the FDA’s statutory jurisdiction. The ruling is grounded in the text, structure, and history of both the FDCA and the Clinical Laboratory Improvement Amendments (CLIA) of 1988, which Congress specifically enacted to govern laboratory testing. -
FDA’s Interpretation Was Not Merely Overbroad—It Was Legally Unsupportable
The Court found that FDA was attempting to redefine intangible professional laboratory services as physical medical devices, which it described as a category error. The judge emphasized that terms like "instrument," "machine," and "in vitro reagent" in the FDCA unambiguously refer to tangible articles, not in-house testing services conducted by trained lab professionals. -
FDA Ignored Legislative Intent and Agency History
The decision meticulously catalogs FDA’s historical abstention from regulating LDTs as devices, noting that for decades FDA exercised “enforcement discretion” but did not assert jurisdiction. That restraint was consistent with Congress’s clear intent that CMS—not FDA—should oversee laboratory services under CLIA. -
Recent FDA Rule Contradicted Past Agency and Congressional Actions
The Court found persuasive evidence that Congress repeatedly declined to legislate FDA authority over LDTs, including bills like the VALID Act and VITAL Act. FDA’s attempt to impose sweeping new requirements without statutory change represented an administrative power grab. -
Enforcement Discretion Offers No Legal Shield
Although FDA promised not to enforce its rule against many labs immediately, the Court held that this non-binding discretion did not cure the underlying illegality. Agencies cannot regulate beyond their statutory limits and then invoke prosecutorial discretion to downplay the impact.
🧪 Who Won and Why?
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Plaintiffs:
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American Clinical Laboratory Association (ACLA)
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HealthTrackRX
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Association for Molecular Pathology (AMP)
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Dr. Michael Laposata
These plaintiffs succeeded in arguing that LDTs are professional services, not commercial devices. The court emphasized that no article of personal property changes hands in an LDT service, and there is no manufactured product to regulate under the FDCA.
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Defendants:
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FDA
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HHS
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Robert F. Kennedy, Jr. (as HHS Secretary)
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Dr. Sara Brenner (Acting FDA Commissioner)
FDA's arguments were found unconvincing and contrary to both law and history.
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🧵 Implications:
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Legal Precedent:
This case will likely become the seminal case on FDA’s limits under the FDCA, especially when it comes to regulating intangible services. -
Regulatory Strategy:
The court signaled that FDA must wait for clear congressional authorization before it can impose sweeping rules on LDTs. Agencies can no longer assume that enforcement discretion or policy shifts suffice. -
CLIA Reaffirmed:
This decision fortifies CMS’s exclusive authority over LDT oversight, ensuring that professional laboratories are regulated as healthcare providers, not device manufacturers.
Would you like a summarized 1-pager or a slide for stakeholder communication?
Your instincts are sound, and your analysis touches the key tension. While the legal basis for appeal is narrow after such a comprehensive loss on statutory grounds, the government may still appeal for strategic or political reasons, particularly if it wants to preserve long-term regulatory authority over LDTs. Let’s break it down:
🔍 What Can FDA Do on Appeal?
1. Reframe the Statutory Interpretation
FDA could attempt a narrower statutory reading argument, claiming that the trial court overly formalized the distinction between devices and services, and that some LDTs involve tangible reagents or instruments developed in-house. But:
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The district court thoroughly dismissed that idea (e.g., distinguishing LDTs from “test kits” and noting that no article of commerce changes hands).
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FDA’s historic position was not consistent on this point, and that inconsistency undermines its deference argument.
2. Argue Congressional Silence Isn’t Prohibitive
FDA might argue that Congress’s failure to act (e.g., not passing VALID or VITAL) doesn't prove prohibition, and try to invoke a more functionalist statutory interpretation. But the Supreme Court’s recent Loper Bright decision cuts that off at the knees—Chevron deference is gone, and courts must now interpret statutes independently.
3. Try to Reframe the “Service vs. Device” Issue as a Mixed Question
FDA may argue that the case turns on a mixed question of law and fact, and therefore some factual deference is warranted. But Judge Jordan wrote a pure statutory interpretation opinion: no factual ambiguity, no APA “arbitrary and capricious” wiggle room. [He could have called FDA arbitrary and capricious, but, it would have thereby opened an appeal window.]
4. Lean Into the Major Questions Doctrine (In Reverse)
Unusually, FDA could try to argue that this isn’t a “major question”—just routine device regulation. That’s a hard sell given the court’s emphasis on multibillion-dollar impacts, decades of FDA restraint, and explicit congressional debate. The major questions framework works against FDA.
🎯 Strategic Considerations: Why Might FDA Appeal Anyway?
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Preserve Institutional Authority
Even if they expect to lose again, the FDA may want to signal that it’s not giving up its turf without a fight. The jurisdictional line between FDA and CMS is still in flux, and this case could define it nationally. -
Avoid Circuit Splits
By appealing, FDA could try to avoid future rulings in other circuits that further fracture the legal landscape. Or—less likely—it may gamble on reversing in the Supreme Court. -
Change of Administration in 2025
If the current administration appeals and stays in office, it can continue pursuing the appeal. If there's a change in administration, an appeal could preserve the rule on life support until the FDA under new leadership potentially withdraws or modifies it, rather than losing outright in court. -
Buy Time and Keep Pressure on Labs
Even a losing appeal could delay finality for a year or more, during which time labs may hesitate to launch high-risk tests or expand LDT services.
🃏 Will They Fold?
You noted that the Trump administration showed up for oral arguments after inauguration and continued backing the case. That's important—it wasn’t a passive handoff.
But now that:
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Chevron is gone, and
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The court vacated the rule in its entirety, and
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CMS's CLIA role has been reaffirmed,
the case has lost most of its strategic high ground. Unless the DOJ is being directed to litigate this as a signal case for FDA authority across domains, folding is a rational option.
Still, FDA may file a notice of appeal to preserve the option, then decide whether to pursue or narrow the appeal after internal consultation—especially after April/May public reaction and political input.
🎬 Summary:
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Legal outlook for appeal: very poor—this was a categorical statutory ruling, not a discretionary one.
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Tactical options: limited and made worse by recent Supreme Court decisions.
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Government behavior: may still appeal to delay, preserve options, or protect institutional authority—but could fold quietly midstream.
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Your prediction (that they might walk away): increasingly likely, unless they're playing a long game on FDA power in diagnostics more generally.
Would you like a mock-up of what a DOJ statement withdrawing the appeal might look like—or alternatively, a concise explainer on the implications for labs in light of this ruling?
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WILL THE GOVERNMENT FOLD ITS CARDS? 40%.
CAN GOVERNMENT WIN? 10%
Given the appeal pathway is via the conservative 5th Circuit, which often agrees with its underlying district judges in this nature of case, what are the odds of the government appealing? (Use a percent). And, if the government appeals, what are the odds of winning at the Fifth Circuit? (Use a percent.)
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Based on the strength of the district court's statutory analysis, the conservative lean of the Fifth Circuit, and the Supreme Court’s recent dismantling of Chevron deference (Loper Bright), here is a reasoned estimate of the government’s likely behavior:
🎯 Odds the Government Appeals:
60%
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In favor of appeal:
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Institutional interest in defending FDA's jurisdictional reach.
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Delay as a strategic tool—buying time, especially in light of pending elections and possibly shifting political control in 2025.
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Preserving optionality: DOJ may file a Notice of Appeal (low cost) even if unsure about pursuing the full appeal.
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Against appeal:
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High likelihood of loss, especially in the Fifth Circuit.
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Supreme Court precedent (Loper Bright) directly undermines FDA's basis.
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No meaningful Chevron wiggle room, and weak fallback arguments.
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A loss at the Fifth Circuit could worsen the precedent nationally.
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Bottom line: The government may file a placeholder appeal to preserve options, even if it ultimately chooses to withdraw or not press it fully. Hence, ~60%.
⚖️ Odds the Government Wins on Appeal in the Fifth Circuit:
10%
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The Fifth Circuit has:
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Repeatedly curtailed agency overreach.
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Explicitly cited the “major questions” doctrine to strike rules down.
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Supported the logic used by Judge Jordan in other administrative law cases.
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Judge Jordan’s ruling is:
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Deeply rooted in the statutory text and structure.
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Supported by historical context and decades of FDA/CMS practice.
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Entirely unaffected by Chevron (even if it were still in place).
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An FDA win would require:
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Reversal on statutory grounds, despite clear textual limitations.
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Acceptance of the idea that a professional service (not a product) is a regulated "device."
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Fifth Circuit willingness to side with agency logic over structural separation of powers.
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Bottom line: Almost no path to win in the 5th Circuit. A 10% estimate is generous and assumes an unexpected panel composition or unusual deference to agency history—neither of which is likely post-Loper Bright.
Let me know if you’d like visuals (charts, timelines) or a strategic memo version of this for broader distribution.
What can the litigants - ACLA, AMP, etc - do to strengthen the chance the government folds its hand? in the form of a strategic memo, as you mention.
Certainly — here's a concise strategic memo tailored for ACLA, AMP, and allied stakeholders. It focuses on legal, political, and public messaging strategies to increase the likelihood the government opts not to pursue an appeal of the recent district court decision striking down the FDA’s LDT rule.
Strategic Memo:
Increasing the Likelihood of Government Non-Appeal in ACLA et al. v. FDA
To: Leadership at ACLA, AMP, HealthTrackRX, and aligned stakeholders
From: Strategy Counsel
Date: March 31, 2025
Re: Action Plan to Encourage Government Non-Appeal of FDA LDT Rule Decision
Objective
To increase the probability that DOJ/FDA declines to appeal the March 31 ruling vacating FDA’s final LDT rule by applying legal, political, and public relations pressure in a coordinated and timely manner.
I. Legal Pressure Points
1. Highlight Futility of Appeal Under Current Law
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Submit or coordinate letters from respected legal scholars (including administrative law and health law experts) explaining that:
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The decision aligns with Loper Bright and other post-Chevron precedents.
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The Fifth Circuit is unlikely to reverse on statutory grounds.
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An appeal would risk enshrining unfavorable national precedent for FDA.
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2. Quiet Amicus Campaign
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Encourage amicus letters to DOJ or HHS General Counsel (not the court), outlining the strategic hazards of appealing a losing case with high visibility and a poor legal footing.
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Focus on institutional legitimacy, not political confrontation.
II. Political and Interagency Pressure
3. Leverage CMS and Capitol Hill Allies
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Engage CMS career and political leadership to reaffirm CLIA as the rightful regulatory home for LDT oversight.
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Work with bipartisan congressional offices (especially from health committees or oversight) to:
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Send oversight inquiries or letters to HHS urging restraint.
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Remind the administration of congressional intent: Congress has repeatedly declined to give FDA this authority.
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4. Coordinate a Senate “Soft-Landing” Narrative
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Reach out to Senate HELP and House Energy & Commerce contacts to suggest that future LDT oversight reform should be legislative, not judicially or bureaucratically imposed.
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Offer to support hearings or roundtables that pull FDA back toward a VALID/VITAL compromise without litigation.
III. Public Messaging and Reputational Framing
5. Shape the Narrative Around Patient Access and Innovation
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Launch op-eds, white papers, and patient stories (especially from rare disease and oncology communities) emphasizing:
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The district court ruling preserves patient access to cutting-edge diagnostics.
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FDA’s rule would have created a multi-billion-dollar regulatory burden with no evidence of improved safety.
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Congress already empowered CLIA to ensure lab quality.
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6. Appeal to Fiscal Moderates
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Use think tanks (e.g., AEI, Manhattan Institute, Brookings) to publish quick analyses showing:
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FDA’s appeal would be an expensive regulatory escalation.
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DOJ/FDA should not spend taxpayer money defending a regulation projected to cost $113B (FDA’s own estimate) with minimal benefit.
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IV. Tactical Timing
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Act before the 60-day appeal window expires (i.e., before May 30, 2025).
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Target internal deliberation windows at DOJ Office of the Solicitor General and HHS General Counsel by mid-April.
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Prepare for a “win by default” if DOJ files a notice of appeal but then quietly lets it lapse or withdraws.
Conclusion
While DOJ may reflexively file a notice of appeal, the odds of ultimate pursuit can be reduced by sustained, multi-pronged messaging focused on legal futility, political overreach, and practical cost. Lining up stakeholders from both industry and patient advocacy sectors will bolster the case for a graceful government exit and refocus oversight debates in Congress, where they belong.
Let me know if you'd like a version of this formatted as a Word/PDF briefing memo, or expanded sections on talking points, press strategy, or Hill outreach targets.
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AI LOOKS BACK TO DECEMBER 2024
Compare your December 2024 prediction of the outcome, and your mockup ruling, with the ACTUAL ruling today.
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Here is a comparison of the December 2024 AI "mock-up ruling" with the actual federal court decision issued on March 31, 2025 in ACLA et al. v. FDA. This side-by-side assessment focuses on key structural, legal, and rhetorical elements.
🔍 OVERALL STRUCTURE & STYLE
| Feature | AI Mock-Up (Dec 2024) | Actual Ruling (Mar 2025) |
|---|---|---|
| Length | ~5 pages | 51-page opinion + 2-page judgment |
| Tone | Concise and explanatory | Formal, detailed, and judicial |
| Remedy | Summary judgment for plaintiffs, rule vacated and remanded | Same: Rule vacated in full, summary judgment for plaintiffs, remanded to HHS |
| Framing | High-level summary of arguments and conclusions | Detailed statutory history, legislative record, agency behavior, and administrative law doctrine |
⚖️ CORE LEGAL HOLDINGS
| Legal Point | AI Mock-Up | Actual Ruling |
|---|---|---|
| FDA lacks statutory authority to regulate LDTs as devices | YES — devices are tangible articles, not professional services | YES — extensive statutory and historical analysis showing LDTs are not devices under FDCA |
| Major Questions Doctrine applies | YES — regulating LDTs is a major economic/political question requiring clear Congressional authorization | IMPLIED but not decided — Court notes the doctrine but rules solely on statutory grounds (p. 23) |
| APA violation: arbitrary and capricious | YES — FDA failed to account for reliance interests and overstated benefits | NOT REACHED — the court vacated the rule solely on jurisdictional/statutory grounds |
| Remedy: Vacatur and remand | YES | YES (Final Rule vacated in its entirety, remanded to HHS) |
🧠 ANALYTICAL DEPTH
| Category | AI Mock-Up | Actual Ruling |
|---|---|---|
| Statutory Analysis (FDCA vs. CLIA) | Explained but brief | Very deep dive into legislative history from 1938 to 2024, contrasting FDCA (devices) and CLIA (services) |
| FDA Historical Behavior | Noted: 30 years of non-enforcement | Extensive documentation of shifting FDA positions, Congressional inaction, and reliance interests (1992–2024) |
| CLIA Oversight Role | Described as the rightful regulator | Affirmed and detailed across multiple pages; CLIA framed as the sole proper framework for LDT oversight |
| Enforcement Discretion | Criticized as unpredictable | Dismissed as legally inadequate — discretionary policies cannot compensate for lack of jurisdiction |
🗣️ RHETORICAL STYLE
| Style Feature | Mock-Up | Actual Ruling |
|---|---|---|
| Judicial Voice | Modeled tone, but simplified | Authentic and authoritative, citing 5th Circuit and Supreme Court precedents |
| Examples/Imagery | General analogies (e.g., contrast with kits) | Concrete examples (e.g., 79,000 existing tests, CMS role, training requirements, AMA comments) |
| Conclusion | "FDA lacks authority, acted arbitrarily, rule vacated" | "FDA lacks authority under FDCA, vacatur required under APA and 5th Circuit precedent" |
🧾 FINAL ORDERS: IDENTICAL
Both the mock-up and actual ruling conclude with:
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Summary judgment for ACLA, AMP, and other plaintiffs
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Denial of FDA's cross-motion
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Vacatur of the FDA's May 2024 Final Rule
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Remand to HHS for further proceedings
🎯 Bottom Line
The December mock ruling anticipated the outcome with remarkable accuracy, both legally and structurally. The actual ruling, however, surpasses it in:
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Depth of legislative and administrative law reasoning
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Documentation of FDA’s shifting policy stance
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Use of APA and FDCA statutory structure to decide the case without invoking the major questions doctrine directly
Would you like a PDF one-pager comparing the two, or a version of this formatted as a press release or advisory memo?
