Cut FDA Final Brief Text

 

Where do the two briefs have the tightest overlap?

The ACLA and AMP briefs overlap significantly in their critiques of the FDA's final rule regulating laboratory-developed tests (LDTs). The key areas of overlap include:

1. Major Questions Doctrine:

   • Both briefs assert that the FDA’s regulation of LDTs represents a significant expansion of regulatory authority requiring clear Congressional authorization, which is absent.
   • Both highlight that Congress has repeatedly declined to authorize such regulation, underscoring the overreach.

2. Definition of a Device under the FDCA:

   • Both argue that LDTs are not “devices” as defined by the FDCA because they involve professional services rather than tangible, manufactured products. They emphasize that LDTs are not commercially distributed and are used within a single laboratory.

3. Conflict with CLIA:

   • Both emphasize that CLIA already provides comprehensive oversight for LDTs, regulating their validity and reliability.
   • They argue that FDA regulation would create unnecessary duplication, conflict with CLIA, and undermine its well-established framework.

4. Economic and Practical Consequences:

   • Both highlight the severe financial and operational burdens the FDA’s rule would impose on laboratories, including billions in compliance costs, disruption of innovation, and reduced patient access to LDTs.
   • They underscore the likelihood of laboratories exiting the market, further harming patient care.

5. Arbitrary and Capricious Rulemaking:

   • Both briefs argue that the FDA’s rule is arbitrary and capricious, lacking a clear rationale or evidence to justify the dramatic shift in regulatory oversight.
   • They critique the FDA’s reliance on enforcement discretion policies as inadequate and inconsistent.

6. Practice of Medicine Exemption:

   • Both highlight statutory protections for healthcare professionals under the FDCA, arguing that the FDA’s rule unlawfully infringes on the practice of medicine by regulating professional services.

These shared arguments reflect a unified stance from the lab industry, emphasizing that the FDA’s final rule oversteps statutory boundaries, conflicts with existing regulation, and would harm patient care and innovation.

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I don't have access to the government's response, that is, the FDA's response and final brief.   However, what can we infer about the FDA's responses and counter-arguments, from the moving parties' final briefs.

While the FDA’s final brief is not available, we can infer key aspects of its arguments and counterpoints based on how the ACLA and AMP briefs respond to and refute them. Here’s an analysis of what the FDA likely argued and how the moving parties addressed those points:

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1. Authority to Regulate LDTs

FDA’s Likely Argument:

• The FDA likely argued that LDTs qualify as "devices" under the FDCA because they involve in vitro diagnostic (IVD) systems, which the agency has historically regulated.
• The FDA may have claimed it has continuously asserted authority over LDTs since the 1970s but has exercised enforcement discretion until now.

Response by ACLA and AMP:

• Both briefs dispute the FDA’s historical authority, emphasizing that LDTs are professional services, not commercially distributed devices.
• They point out that the FDA has inconsistently applied its claimed authority, with decades of non-enforcement undermining its position.
• The AMP brief argues that relying on broad definitions of terms like "device" (e.g., “apparatus” or “contrivance”) would sweep in unrelated medical procedures, exceeding statutory intent.

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2. Commercial Distribution Requirement

FDA’s Likely Argument:

• LDTs involve “commercial distribution” because laboratories provide testing services for a fee, and the FDA’s statutory authority covers commercially provided services.

Response by ACLA and AMP:

• Both briefs argue that “commercial distribution” under the FDCA applies to tangible goods transferred to third parties, not internal laboratory procedures.
• AMP highlights that applying this interpretation to LDTs would render the statutory language meaningless, as procedures cannot be “distributed.”

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3. Compatibility with CLIA

FDA’s Likely Argument:

• The FDA likely argued that CLIA and FDA regulation target different aspects of test oversight: CLIA focuses on laboratory operations and analytical validity, while the FDA focuses on clinical validity and patient safety.

Response by ACLA and AMP:

• Both briefs reject this distinction, asserting that CLIA already ensures both analytical and clinical validity through proficiency testing and other mechanisms.
• AMP argues that FDA regulation would create unnecessary duplication and conflict, effectively undermining the existing CLIA framework.

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4. Major Questions Doctrine

FDA’s Likely Argument:

• The FDA likely attempted to downplay the significance of its rule under the major questions doctrine, arguing that its regulation of LDTs is consistent with its long-standing statutory authority.

Response by ACLA and AMP:

• Both briefs counter that the FDA’s sudden assertion of broad regulatory authority over LDTs constitutes a “transformative expansion” requiring explicit Congressional authorization, which has not been granted.
• They highlight Congress’s repeated refusal to authorize such regulation, suggesting that the FDA’s actions lack clear statutory backing.

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5. Economic and Practical Impacts

FDA’s Likely Argument:

• The FDA may have argued that the costs associated with compliance are justified by the need to ensure the safety and efficacy of LDTs, given their critical role in patient care.

Response by ACLA and AMP:

• Both briefs emphasize the disproportionate costs and practical burdens, projecting billions in compliance costs, laboratory closures, and diminished patient access to innovative tests.
• They argue that these impacts are avoidable under the current CLIA framework, which effectively regulates test quality without stifling innovation.

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6. Practice of Medicine Exemption

FDA’s Likely Argument:

• The FDA may have argued that the practice of medicine exemption under the FDCA does not shield laboratories or affiliated entities from regulation, as it is narrowly tailored to individual practitioners.

Response by ACLA and AMP:

• Both briefs assert that the exemption protects not only individual practitioners but also their affiliated entities (e.g., laboratories), as regulation of one inevitably impacts the other.
• AMP emphasizes that holding laboratories liable for LDT practices would undermine Congress’s intent to shield healthcare providers from regulatory overreach.

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7. FDA’s Rulemaking Process

FDA’s Likely Argument:

• The FDA likely defended its rulemaking as consistent with administrative law principles, claiming it carefully considered stakeholder input and based the rule on statutory mandates.

Response by ACLA and AMP:

• Both briefs argue the rule is arbitrary and capricious, citing inadequate justification for the regulatory shift and failure to address the historical reliance on CLIA oversight.
• AMP specifically critiques the FDA’s reliance on non-binding enforcement discretion policies, calling them insufficient and inconsistent.

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Inferred Strategy of the FDA

• The FDA likely sought to expand the statutory definitions and historical interpretations of the FDCA to encompass LDTs, focusing on patient safety as a justification for regulatory oversight.
• It probably downplayed the potential conflicts with CLIA and the economic impacts of the rule, while asserting that it has the authority to act in the absence of explicit Congressional prohibition.

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Conclusion

From the ACLA and AMP responses, it is clear that the FDA’s arguments hinge on broad statutory interpretations, historical assertions of authority, and a separation of regulatory focus between CLIA and the FDCA. However, both briefs effectively challenge these positions by emphasizing statutory text, legislative history, and the practical consequences of the FDA’s actions. This alignment suggests a strong unified opposition to the FDA’s rule within the lab industry.

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What arguments are unique to ACLA or unique to AMP?

there are several noteworthy arguments unique to either the ACLA or AMP closing briefs, reflecting their differing emphases and approaches to opposing the FDA’s final rule:

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Arguments Unique to the ACLA Closing Brief

1. FDA's Inconsistent Enforcement History:

   • ACLA places significant emphasis on the FDA’s inconsistent enforcement of its purported authority over LDTs, using this as evidence that the agency itself has historically acknowledged its limited authority in this area.

2. Focus on Economic Disruption:

   • While both briefs discuss economic impacts, ACLA provides a broader analysis of how the rule would disrupt the entire clinical laboratory sector, emphasizing the financial burden on smaller labs and its chilling effect on innovation.

3. Role of Laboratories as Service Providers:

   • ACLA delves deeper into the distinction between laboratories as service providers (under CLIA) versus manufacturers (under the FDCA). This framing underscores that LDTs are services, not products, and challenges the FDA’s attempt to conflate the two.

4. Critique of FDA’s Ad Hoc Enforcement Policies:

   • ACLA specifically critiques the FDA’s reliance on non-binding "enforcement discretion" policies to mitigate the rule's effects, arguing that such policies highlight the rule’s impracticality and lack of clarity.

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Arguments Unique to the AMP Closing Brief

1. Practice of Medicine Exemption:

   • AMP places greater emphasis on the FDCA’s practice of medicine exemption, arguing that the FDA’s rule undermines this long-standing protection for healthcare professionals and their affiliated entities.
   • AMP highlights how the exemption applies to individual practitioners and their associated laboratories, reinforcing that the rule would unlawfully penalize laboratories for activities intrinsic to medical practice.

2. Conflict with CLIA’s Comprehensive Regulation:

   • While ACLA critiques the overlap between FDA and CLIA oversight, AMP goes further by arguing that the FDA’s rule would render key CLIA provisions superfluous, creating direct regulatory conflicts.
   • AMP specifically points to how CLIA already addresses both analytical and clinical validity, undermining the FDA’s justification for additional oversight.

3. Detailed Examination of the Major Questions Doctrine:

   • AMP provides a more in-depth discussion of the major questions doctrine, analyzing how Congress’s repeated refusal to grant the FDA authority over LDTs highlights the absence of clear Congressional authorization for the rule.

4. Use of Analogies to Surgical Procedures:

   • AMP draws a novel analogy between the development of LDTs and the design of surgical procedures, arguing that the FDA’s expansive interpretation of “device” could criminalize standard medical practices like surgery, thereby demonstrating the unworkability of the FDA's position.

5. Critique of FDA’s Statutory Interpretation:

   • AMP takes a nuanced approach to challenging the FDA’s interpretation of statutory terms like “apparatus” and “contrivance,” employing canons of statutory construction to argue that the FDA’s definitions are overly broad and inconsistent with Congressional intent.

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Summary of Unique Contributions

• ACLA focuses on the practical and economic impacts of the rule, emphasizing the financial and operational burdens on laboratories, and critiques the FDA’s historical inconsistencies in asserting its authority.
• AMP, on the other hand, provides a more legalistic critique, emphasizing statutory construction, the practice of medicine exemption, and the conflict with CLIA, while employing analogies and canons of interpretation to challenge the FDA’s arguments.

These distinctions reflect complementary strategies, with ACLA targeting the rule’s real-world implications and AMP focusing on the legal framework. Together, they form a robust opposition to the FDA’s final rule.