ACLA submitted a 107-page comment on the FDA LDT proposal. Source here:
https://www.discoveriesinhealthpolicy.com/2023/12/acla-issues-107-page-comment-against.html
I asked GPT4 and CLAUDE to make summaries.
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GPT4
The American Clinical Laboratory Association (ACLA) submitted a detailed comment on the FDA's Proposed Rule to regulate laboratory developed tests (LDTs) as medical devices. The ACLA argues that this would significantly undermine the ability of laboratories to develop and offer innovative LDTs, essential for providing diagnostic information, powering precision medicine, and leading the fight against emerging pathogens. If implemented, the rule would reduce patient access to LDTs, including those without FDA clearance or approval, and significantly diminish diagnostic innovation due to the rigidity of device regulations.
The ACLA highlights several key issues with the Proposed Rule:
Adverse Impact on Innovation and Access: The rule would force laboratories to divert resources from research and development to backward-looking activities for FDA approval. This shift would likely lead to the removal of low-volume tests, including those for rare diseases, from test menus, impacting the development of next-generation diagnostics and novel biopharmaceuticals. It would also reduce testing capacity, affecting patient access to testing services, especially for underserved populations.
Administrative Burdens: The proposed changes come at a time of reduced reimbursement for testing, escalating costs, and a workforce shortage in laboratories. The device regulatory framework, deemed unsuitable for LDTs, would impose significant direct costs and stifle the rapid evolution in diagnostic services necessary in fields like oncology and neurology.
Oncology Tests: LDTs are crucial in oncology, where they incorporate the latest scientific developments to inform the judgment of professionals. The FDA's requirement for lengthy premarket review would hinder this rapid innovation, adding months or years to the development lifecycle of new LDTs, potentially affecting patient outcomes.
FDA Review Bottleneck: The implementation of device regulation would overwhelm the FDA, creating a significant bottleneck. The FDA's workload would increase dramatically, exceeding its capacity based on historical data and experience from the COVID pandemic. This bottleneck would draw resources away from medical product development, impacting the entire healthcare system.
Mischaracterization and Flawed Data: The ACLA criticizes the FDA for failing to acknowledge the robust existing regulation of LDTs and their significant public health contributions. The FDA's reliance on anecdotal, unverified, and cherry-picked data to support the Proposed Rule is seen as profoundly inaccurate.
Cost-Benefit Analysis Issues: The FDA's reliance on flawed data and assumptions led to an underestimation of costs and an overstatement of benefits in the Proposed Rule. The ACLA argues that the rule would likely cause many important LDTs to be withdrawn, not due to their quality, but because of the impracticality of meeting the rigid requirements of medical device regulation.
Legal Concerns: The ACLA argues that the Proposed Rule is illegal because the FDA lacks the authority to regulate LDTs as devices. The FDCA's statutory authority extends to physical products sold and distributed by manufacturers, whereas LDTs are services provided by trained professionals. The development and performance of LDTs are regulated under CLIA and complementary state laws, not the FDCA. The ACLA contends that FDA's assertion that LDTs are devices is as misguided as labeling a surgical procedure a device.
Alternative Approaches and Conclusion: While the ACLA acknowledges the FDA's solicitation of input on alternative approaches, it maintains that none would resolve the fundamental legal and policy issues with imposing device law on testing services. The ACLA urges the withdrawal of the Proposed Rule and suggests that the FDA engage with stakeholders, other HHS agencies, and Congress to develop appropriate regulatory authority for LDTs.
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Claude
The American Clinical Laboratory Association (ACLA) submitted extensive comments opposing the FDA's proposed rule to regulate laboratory-developed tests (LDTs) as medical devices. ACLA argues the rule would undermine innovation, limit access to testing, exceeds FDA’s legal authority, and is based on flawed data.
ACLA asserts LDTs are services, not devices, and applying device requirements is unsuitable and would divert resources from advancement to compliance, reduce testing access, and cause important tests to be withdrawn as the rigid framework precludes keeping pace with science. Imposing regulations would also overwhelm FDA, slowing availability of all diagnostics.
Further, ACLA contends LDTs are already stringently regulated under federal and state laws, accredited bodies, and payers, contrary to FDA’s depiction. LDTs have delivered groundbreaking innovations, rapidly responded to emerging threats, aided drug/biologic development, and offered critical tests where cleared options were unavailable.
Additionally, ACLA argues FDA’s critique of LDTs uses unreliable, cherry-picked data. Out of an estimated 80,400 available LDTs, FDA identified issues with 160, merely 0.2%. FDA’s specific COVID-19 and oncology LDT examples are also disputed.
Moreover, ACLA asserts FDA severely underestimates compliance costs and overstates benefits via flawed studies. Quantifying ancillary costs and accurately valuing benefits reveals expenses markedly outweigh savings.
Legally, ACLA states LDTs fall outside FDA jurisdiction as services, not devices. Subsequent legislation on laboratories confirms this. Regulating LDTs would also raise constitutional concerns, limit medical practice, and violate rulemaking procedures.
While adjustments could reduce harm, none solve fundamental issues. Instead, FDA should not finalize this proposed rule and develop any new oversight collaboratively with stakeholders and Congress
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Prompt used for both:
Please summarize this federal comment letter about lab tests in about 500 words. You are writing for health lawyers and other medical technology experts who are highly familiar with the lab industry, but do not have time right now to read the 107 page comment. Thank you, we really appreciate your help.
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I asked GPT4 to compare the two summaries shown above - here.
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In the same format, I used GPT4 and CLAUDE to summarize my own 15 page white paper on FDA LDT:
https://brucedocumentblog.blogspot.com/2023/12/ai-corner-chat-gpt4-and-claude.html
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