Thanks to CAP Advocacy News for providing links to final closing briefs newly filed by ACLA and AMP in the FDA LDT court case.
https://documents.cap.org/documents/acla-closing-brief2024.pdf
https://documents.cap.org/documents/amp-closing-brief2024.pdf
They weigh in at 32pp and 34pp, respectively, dated-stamped 11-25-2024.
The AMP brief discusses MolDx (p. 20).
ACLA writes (p2) "Unable to defend the agency's untenable position, FDA's lawyers double down on a strategy of obfuscation and definitional sleight of hand."
They note that 1976 device law specific limited FDA control to "devices" and "in vitro reagents" [less than a device], and not "processes" like LDTs.
They emphasize than at LDT is not an object or item placed into interstate commerce. They distinguish lab procedures from software (SaMD) because software is actually tangible, e.g., a downloaded computer file transferred from one place to another [w/ citations to court cases on SaMD].
Much is made of the legislative intent of CLIA vs FDA; CLIA specifically allows for FDA IVD's to be modified and become LDTs under CLIA; that ability doesn't make sense if it is simultaneously illegal to do so under FDA law.
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[Particularly colorful is the ACLA's 9/2024, 51-page entertaining and lively motion for summary judgement including their hatchet job on FDA's attempts to defend itself - here. Discussed at bottom of blog.]
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AI Corner - Chat GPT 4o
Summary Argument:
FDA’s Overreach on Laboratory-Developed Tests (LDTs)
Introduction: A Health Law Perspective
The U.S. Food and Drug Administration (FDA) has overstepped its statutory authority by asserting that Laboratory-Developed Tests (LDTs) constitute "medical devices" under the Federal Food, Drug, and Cosmetic Act (FDCA). This unprecedented move disrupts decades of regulation under the Clinical Laboratory Improvement Amendments (CLIA), which govern laboratory services as professional healthcare activities. The FDA’s Final Rule embodies what legal scholars term a “major questions” case—an agency claiming vast, newfound authority with no clear Congressional mandate. This interpretation risks undermining medical innovation and threatening access to vital diagnostic services.
Key Legal and Regulatory Issues
Misinterpretation of "Device": The FDCA defines a device as a tangible, manufactured product intended for use in medical contexts. FDA's attempt to include intangible testing procedures or protocols under this definition stretches the statutory language beyond recognition. Laboratory protocols are services, not manufactured goods, and cannot reasonably be categorized as "devices".
Violation of the Commercial Distribution Requirement: LDTs are created and used within a single laboratory, lacking the commercial distribution element required under FDCA’s regulatory scope. By targeting these tests, the FDA misrepresents the statutory requirement for regulating goods in interstate commerce.
CLIA’s Authority over LDTs: Congress explicitly designated CLIA as the regulatory framework for laboratory services, focusing on accuracy and reliability through licensure and professional oversight. FDA's encroachment disregards this statutory division, conflating manufacturing oversight with clinical practice regulation.
FDA’s Deficient Legal Justifications
FDA’s arguments rely on definitional manipulation and unsupported analogies:
- Redefining "Manufacturing": FDA contends that developing or using testing protocols equates to manufacturing a device. This conflation ignores that protocols do not create a tangible product; they represent professional expertise and procedural development.
- Shifting Interpretations: FDA asserts that it has historically claimed authority over LDTs since the 1970s, yet this claim lacks enforcement history. Courts should not legitimize what amounts to "regulatory adverse possession"—an agency retroactively asserting long-dormant authority.
Major Questions Doctrine
The Supreme Court has consistently held that transformative regulatory claims require explicit Congressional authorization. FDA’s assertion fails this test:
- Economic and Professional Impact: The rule disrupts a significant healthcare sector, imposing billions in compliance costs while criminalizing longstanding medical practices.
- Legislative Silence: Congress has repeatedly declined to grant FDA authority over LDTs, further highlighting the agency’s overreach.
Arbitrary and Capricious Rulemaking
FDA's reliance on non-binding “enforcement discretion” policies demonstrates the weakness of its legal interpretation. By admitting that laboratories could be prosecuted at any time for routine activities, FDA injects uncertainty into essential diagnostic services. This ambiguity underscores the arbitrary nature of the Final Rule.
Conclusion
FDA’s Final Rule represents a sweeping and legally unfounded attempt to regulate professional healthcare services as if they were manufactured goods. By conflating laboratory-developed protocols with tangible devices, the agency jeopardizes patient care, medical innovation, and the integrity of administrative law. Courts must vacate this rule, as it exceeds statutory limits, disregards Congressional intent, and undermines the longstanding division between CLIA and FDCA authority.
As the plaintiffs aptly summarize: “Unable to defend the agency's untenable position, FDA's lawyers double down on a strategy of obfuscation and definitional sleight of hand.” \
This Court should reject this overreach to preserve the integrity of laboratory services.
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AI Corner (Chat GPT 4o)
ACLA Closing Brief
The American Clinical Laboratory Association (ACLA)'s closing brief presents a robust critique of the FDA's final rule, centered on the legal interpretation of whether laboratory-developed tests (LDTs) and testing protocols constitute "devices" under the Federal Food, Drug, and Cosmetic Act (FDCA).
Key Arguments from the ACLA Brief
Definition of a Device:
ACLA argues that the FDCA's definition of a "device" is limited to tangible, manufactured products, such as instruments or test kits. Laboratory testing protocols, by contrast, involve professional services and the use of physical tools but do not constitute a "device" themselves. The brief emphasizes the inconsistency of FDA's claims with statutory language and historical interpretation of the FDCA.CLIA vs. FDCA Jurisdiction:
ACLA asserts that the Clinical Laboratory Improvement Amendments (CLIA) already provide a comprehensive regulatory framework for laboratory services, focusing on analytical and clinical validity. CLIA's regulatory scope, combined with its professional licensing standards, highlights the professional-service nature of LDTs, further distinguishing them from the FDA-regulated manufacturing of devices.Major Questions Doctrine:
The brief invokes the doctrine to argue that the FDA's reinterpretation of its authority to regulate LDTs represents a "transformative" change that lacks explicit Congressional authorization. Such a significant expansion of regulatory scope requires clear statutory language, which is absent here.Economic and Practical Impacts:
ACLA critiques the rule as imposing massive compliance costs and regulatory burdens on laboratories, disrupting established practices. The brief points out that FDA's own carveouts and "enforcement discretion" policies demonstrate the impracticality and overreach of its interpretation.Ad Hoc Enforcement Policies:
The brief challenges FDA's reliance on non-binding enforcement discretion to mitigate the rule's harsh impacts, calling it arbitrary and an acknowledgment of the rule's flaws.
Analysis and Insights
Tangible vs. Intangible:
A central theme in ACLA's argument is the distinction between tangible goods (e.g., test kits) and professional services. This distinction is crucial for laboratories to argue that the development of LDTs involves the application of expertise and established protocols, not the creation of new devices.Historical and Statutory Context:
By contrasting the FDA's current claims with decades of regulatory practice, ACLA underscores the absence of precedent for treating laboratory protocols as devices. This lends credibility to its assertion that FDA's action is a regulatory overreach.Broader Implications for the Lab Industry:
If the FDA's final rule stands, laboratories may face dual regulatory burdens under CLIA and the FDCA, leading to increased costs and delayed innovation. This could particularly impact smaller labs and their ability to offer customized tests for unique clinical needs.
Takeaway for the Lab Industry
- Regulatory Advocacy: Laboratories must actively engage in the regulatory process, emphasizing the professional nature of their work and the existing adequacy of CLIA oversight.
- Compliance Strategy: Lab directors should prepare for potential changes by evaluating their current practices in light of FDA's final rule while also contributing to industry efforts to challenge or clarify regulatory boundaries.
- Legal Vigilance: The use of doctrines like major questions and rule of lenity reflects the high stakes and legal complexity of this issue, suggesting a need for continued monitoring of judicial outcomes.
ACLA's brief frames a compelling argument for rejecting FDA's final rule, portraying it as an unlawful expansion of authority with significant adverse consequences for the lab industry. The industry should draw on these arguments to advocate for clear and practical regulatory distinctions between devices and professional laboratory services.
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AMP
Review of the AMP Closing Brief
The Association for Molecular Pathology (AMP)'s closing brief offers a detailed critique of the FDA’s final rule asserting regulatory authority over laboratory-developed tests (LDTs).
Key Arguments from the AMP Brief
Major Questions Doctrine:
- Unprecedented Scope: AMP argues that the FDA’s claim to regulate LDTs under the FDCA invokes the “major questions doctrine,” requiring clear Congressional authorization. The brief emphasizes that the FDA has overstepped by attempting to regulate an area traditionally left to CLIA and professional discretion.
- Economic and Political Significance: AMP underscores that subjecting LDTs to FDA regulation will impose extraordinary costs (estimated in billions) and stifle innovation, directly impacting patient care. Congress has repeatedly declined to authorize such regulation, highlighting the legislative void.
Conflict with FDCA:
- Definition of a Device: AMP asserts that LDTs, which involve professional services rather than tangible, commercial products, fall outside the statutory definition of a "device" under the FDCA.
- Commercial Distribution Requirement: LDTs are developed and used within the same lab, without being distributed commercially. AMP argues that the FDA’s attempt to apply the FDCA to non-commercial activities misinterprets the statute.
- Practice of Medicine Exemption: The brief highlights statutory protections for healthcare practitioners under the FDCA, asserting that the FDA’s rule violates these exemptions by penalizing laboratories for using and modifying diagnostic tools.
CLIA vs. FDCA Jurisdiction:
- Separate Regulatory Schemes: AMP contends that Congress designed CLIA to oversee the quality and validity of laboratory tests, including LDTs, making FDA oversight duplicative and unnecessary. The brief highlights that CLIA already ensures analytical and clinical validity through proficiency testing and quality controls.
- No Overlap in Authority: AMP emphasizes that FDA's regulation of LDTs would disrupt CLIA’s comprehensive framework, creating regulatory conflicts that Congress never intended.
Arbitrary and Capricious Rulemaking:
- Lack of Evidence: AMP critiques the FDA for failing to provide adequate justification for the rule, particularly in light of the agency’s historical non-enforcement and the existing oversight under CLIA.
- Economic Burden: The brief emphasizes the disproportionate costs of the rule, which would force laboratories to abandon innovative tests, disrupt patient care, and overburden the FDA itself with regulatory demands.
Analysis and Insights
The Legal Foundation of LDTs as Professional Services:
- AMP effectively distinguishes LDTs from commercial devices by framing them as integral to the practice of medicine. This argument positions laboratories as extensions of clinical decision-making rather than as manufacturers of products.
Historical and Statutory Context:
- By referencing Congress’s repeated refusal to grant FDA authority over LDTs, AMP strengthens its claim that the FDA’s final rule lacks statutory support. The reliance on legislative history and previous regulatory practice supports AMP’s interpretation of Congressional intent.
Regulatory Overlap Between CLIA and FDA:
- The brief convincingly argues that CLIA adequately regulates the reliability and safety of LDTs. AMP’s position that FDA oversight would disrupt existing processes resonates with stakeholders wary of redundant regulation.
Economic and Practical Consequences:
- AMP’s detailed cost analysis highlights the real-world implications of FDA overreach. The estimated financial burden and potential harm to patient access and innovation amplify the argument that FDA regulation is unjustified.
Takeaway for the Lab Industry
- Advocacy for Legislative Clarity: The lab industry should continue to advocate for clear statutory boundaries, emphasizing the professional and non-commercial nature of LDTs.
- Collaboration with CLIA: Laboratories should highlight the efficacy of CLIA’s regulatory framework in ensuring test quality, while showcasing its flexibility for innovation.
- Preparing for Potential Changes: Even as AMP’s arguments challenge the FDA’s authority, laboratories should assess compliance strategies in the event of regulatory shifts, while supporting industry-wide litigation efforts.
The AMP brief underscores a cohesive argument against FDA overreach, emphasizing the role of LDTs in advancing patient care under existing CLIA oversight. Its detailed analysis provides a strong foundation for resisting the final rule, with significant implications for the lab industry.
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Here is the September 2024 ACLA motion for summary judgment, MSJ, which seems more legalistic than the closing memoradum. Discuss?
The ACLA’s Motion for Summary Judgment is indeed more detailed and legalistic than the ACLA’s Closing Brief, which is consistent with their distinct purposes. Below is a detailed comparison and analysis based on the content of the Motion for Summary Judgment (MSJ):
Nature of the Motion for Summary Judgment (MSJ)
The Motion for Summary Judgment is a legal document filed mid-case to argue that the court should rule in the plaintiff's favor on specific issues because there are no disputed material facts requiring a trial. It is highly focused on statutory interpretation, precedent, and administrative law principles, often citing detailed legal authorities to demonstrate why the agency’s actions are invalid.
Comparison of Content with the Closing Brief
Legalistic Framework and Depth of Analysis:
- The MSJ engages deeply with the statutory text, legislative history, and judicial precedent, often invoking specific Supreme Court cases (e.g., West Virginia v. EPA, FDA v. Brown & Williamson Tobacco Corp.) and applying principles like the major questions doctrine.
- The Closing Brief, while still grounded in legal arguments, is broader and more rhetorically persuasive, summarizing key arguments made earlier in the litigation and focusing on policy impacts and the broader narrative of FDA overreach.
Focus on Administrative Procedure Act (APA) Violations:
- The MSJ details the procedural flaws in the FDA’s rulemaking, including its failure to justify the rule adequately under the APA. It heavily critiques the FDA’s reliance on "enforcement discretion" to defend its regulation, arguing that this creates arbitrary and capricious standards.
- The Closing Brief mentions APA violations but in a more summary fashion, emphasizing their impact on the laboratory industry rather than the technicalities of administrative law.
Reliance Interests and Economic Analysis:
- The MSJ emphasizes reliance interests, discussing how laboratories, clinicians, and patients have operated under CLIA’s framework for decades. It quantifies the economic burden of the FDA’s rule (e.g., billions in compliance costs, reduction in test availability).
- The Closing Brief simplifies these arguments for persuasive effect, using them as evidence of the rule's impracticality.
Statutory Interpretation:
- The MSJ dedicates substantial effort to dissecting the FDCA’s definition of “device” and arguing that laboratory-developed tests (LDTs) are professional services, not tangible products. It also critiques the FDA’s use of enforcement discretion as a means to bypass statutory limits.
- The Closing Brief echoes these points but frames them in the context of broader consequences for the healthcare system.
Major Questions Doctrine:
- The MSJ elaborates extensively on this doctrine, arguing that the FDA’s rule represents a transformative expansion of authority without clear Congressional authorization, making it a textbook case for judicial skepticism.
- The Closing Brief includes this argument but with less technical analysis, focusing on the doctrine's broader implications for agency overreach.
Notable Legalistic Features in the MSJ
- Specific Legal Citations: The MSJ cites over 50 cases, statutes, and regulatory texts to support its arguments, demonstrating a meticulous legal foundation.
- Detailed Legislative History: It reviews decades of legislative efforts (e.g., failed attempts to pass the VALID Act) to argue that Congress deliberately chose not to grant FDA authority over LDTs.
- Analytical Structure: The MSJ breaks arguments into fine-grained subpoints (e.g., textual interpretation, legislative intent, reliance interests), providing a systematic roadmap for the court.
Conclusion
The ACLA’s Motion for Summary Judgment is substantially more legalistic, detailed, and technical than its Closing Brief. While the Closing Brief synthesizes and highlights key arguments for persuasive effect, the MSJ digs deeply into the statutory, procedural, and doctrinal aspects of the case to build a strong foundation for judicial review. This depth is necessary at the summary judgment stage to demonstrate that the facts and law conclusively favor the plaintiff without requiring a trial.
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If the ACLA argues that a device must be a tangible, physical product, where does that leave a separate topic, the FDA's extensive regulation of software as a medical device? This isn't of issue to ACLA, but it would be salient to a judge or FDA.
The FDA’s extensive regulation of Software as a Medical Device (SaMD) presents a potential counterpoint to the ACLA’s argument that a “device” under the FDCA must be a tangible, physical product. This issue, while not directly addressed by ACLA, could be salient for a judge or the FDA as it relates to the broader interpretation of the FDCA’s scope. Here’s an analysis of how this might influence the case:
1. FDA’s Approach to Software as a Medical Device
The FDA has long regulated certain types of software as medical devices, particularly under its SaMD framework, which encompasses:
- Standalone software designed to diagnose, treat, or prevent disease.
- Clinical decision support systems (CDSS), when they meet the FDCA’s definition of a device.
This regulatory framework has been upheld because software, although intangible, can have medical functionality comparable to traditional devices. Courts and regulators have accepted this broader interpretation of “device” under the FDCA when it aligns with the statute’s purpose of protecting public health.
2. Potential FDA Argument Based on SaMD Precedent
The FDA could argue:
- Functional Equivalence: Like SaMD, LDTs may not be tangible products, but their functions—diagnosing or guiding treatment—align with the FDCA’s purpose to regulate devices that impact patient care.
- Broad Definition of “Device”: The FDCA defines a device as an “instrument, apparatus, implement, machine, contrivance...or other similar or related article,” which could encompass intangible processes or services if they perform equivalent functions to regulated devices.
- Precedent for Intangible Products: The regulation of SaMD demonstrates that the FDCA is not limited to physical, tangible items.
3. Distinction Between SaMD and LDTs
ACLA could counter this argument by emphasizing distinctions between SaMD and LDTs:
- Tangible Input: SaMD often operates on tangible data from physical devices (e.g., imaging systems, wearables). LDTs, however, involve laboratory protocols applied to patient samples, aligning more closely with professional services.
- Service vs. Product: LDTs are embedded in laboratory services and involve clinical expertise, making them fundamentally different from standalone software products designed for commercial use.
- Historical Scope of Regulation: Unlike SaMD, which has been explicitly addressed in FDA guidance and international standards (e.g., IMDRF SaMD documents), LDTs have been historically regulated under CLIA as professional services, not devices.
4. Judicial Considerations
A judge might consider:
- Consistency in Regulation: Does regulating LDTs as devices create inconsistencies with FDA’s approach to SaMD or does it harmonize with the broader regulatory framework?
- Legislative Intent: The FDCA’s application to SaMD has been accepted partly because software serves as a direct surrogate for traditional devices. Does Congress intend the same logic to apply to LDTs, which have historically been treated as professional services?
- Regulatory Overreach: Courts have upheld SaMD regulation within limits. However, applying the SaMD analogy to LDTs might be seen as overreach, particularly if it conflicts with CLIA and established reliance interests.
Conclusion
While the FDA’s regulation of SaMD provides a precedent for applying the FDCA to intangible products, LDTs are distinguishable as professional services rather than products. This distinction may allow ACLA to argue that the functional equivalence between SaMD and tangible devices does not extend to LDTs. However, judges may find the SaMD precedent persuasive if they adopt a broader view of the FDCA’s scope, potentially creating a challenge for ACLA’s narrower, tangible-product interpretation of “device.”
