I heard an excellent new podcast about FDA LDT regulation and I wondered what Chat GPT 4 would make of it. Featured speakers are Jennifer Leib and Elliott Cowan; the podcast is from the diagnostics consultancy HALTERES.
I'll give introductory material from the podcast website, and then ask GPT4 to opine.
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https://podcasts.apple.com/us/podcast/halteres-presents/id1675559229?i=1000660885191
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On this week's episode, Rich Thayer and Mickey Urdea are hosting Jennifer Leib and Elliot Cowan for their first-ever roundtable discussion in order to parse through the ramifications of the FDA's recent final rule on laboratory-developed tests (LDTs), which amends FDA regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. This new LDT regulation has massive implications for test developers, patient care, and the FDA itself, so having Jennifer and Elliot, who possess very different experiences and opinions on the FDA's final rule, on the podcast together for this special roundtable discussion was critical for putting the new rule and its fallout in the proper context. This unique, frank conversation is a one-of-a-kind opportunity to see the whole picture of this complicated subject matter; please enjoy.
Jennifer Leib is a board-certified genetic counselor and experienced government affairs professional with an expertise in genomics and precision medicine policy, having studied at the undergraduate program at University of Michigan and the masters program at Johns Hopkins University. She is the founder of Innovation Policy Solutions (iPolicy), a leading government affairs consulting firm that promotes innovation through policy change. The firm actively advises and advocates on behalf of patients, providers, and innovators in laboratory medicine, precision medicine, public health, synthetic biology, gene therapy, neuroscience, rare diseases, and more. Grounded in a foundation of scientific expertise, iPolicy identifies data-driven solutions to health and science policy issues and builds coalitions of support to drive the adoption of clinical advances and enhance patient access to cutting-edge diagnostics and therapeutics. iPolicy is headquartered in Washington and supports clients across the country.
Elliot Cowan is the founder and principal of Partners in Diagnostics after 20 years of service at the US Food and Drug Administration (FDA). As Chief of the Product Review Branch in the Division of Emerging and Transfusion Transmitted Diseases at FDA’s Center for Biologics Evaluation and Research, he was responsible for the regulatory oversight of all blood donor screening tests and retroviral diagnostics, covering every facet of the regulatory review process. He served as chair or supervised the review of numerous IVD applications, as well as acting as the product expert for manufacturing facility inspections. He played key roles in the development of policy, coordinating decisions on issues such as the approval and use of the first of rapid HIV tests and the first over-the-counter HIV test system. He served as the Chair of the HIV Diagnostics Subcommittee of the Laboratory Technical Working Group in the President’s Emergency Plan for AIDS Relief (PEPFAR), and assisted the World Health Organization in the development of its Prequalification of Diagnostics Programme. Elliot received a BA from Williams College and a PhD in biology and biomedical sciences from Washington University in St. Louis.
Podcast Summary: New FDA Efforts to Regulate Lab-Developed Tests (LDTs)
Overview: In this episode, Rich Thayer and Mickey Urdea host Jennifer Leib and Elliot Cowan for a roundtable discussion on the FDA's new final rule regarding laboratory-developed tests (LDTs). This regulation states that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act), even when developed by laboratories, significantly impacting test developers, patient care, and the FDA itself.
Key Participants:
- Jennifer Leib: Genetic counselor and government affairs professional with expertise in genomics and precision medicine policy. Founder of Innovation Policy Solutions.
- Elliot Cowan: Founder of Partners in Diagnostics and former FDA official with extensive experience in regulatory oversight of blood donor screening tests and retroviral diagnostics.
Main Points of Discussion:
Background and History:
- The debate over FDA regulation of LDTs has been ongoing for over two decades.
- Past efforts included the 2014 FDA draft guidance for regulatory compliance, which was never finalized.
- Recent legislative proposals, such as the VALID Act, almost became law in 2022.
- The new FDA final rule adds a clause to the definition of IVDs, explicitly including laboratory-developed products under FDA medical device regulations.
Implications of the New Rule:
- Laboratories must comply with medical device regulations, phasing out the FDA’s previous enforcement discretion over four years.
- Laboratories with existing LDTs are allowed to continue offering them but must meet FDA standards for new or significantly modified tests.
- Concerns about the FDA’s ability to handle the increased workload without additional resources, as recent budget cuts could hinder implementation.
Concerns and Challenges:
- Potential for delays in innovation and patient access due to extended timelines and increased costs for compliance.
- Risk of creating monopolies in testing, limiting patient options for confirmatory tests and increasing costs.
- FDA’s rule could disrupt current practices, especially in rural and underserved areas, where local laboratories may struggle to comply.
Potential Benefits:
- FDA argues the rule will enhance patient safety by ensuring all tests meet rigorous standards.
- Increased oversight may prevent adverse events associated with unvalidated tests.
Industry Reaction and Future Outlook:
- Mixed reactions from the diagnostics community; both laboratory developers and device manufacturers face challenges.
- Legal and legislative pushback, including lawsuits and potential Congressional action, could influence the final implementation.
- The innovation cliff is a significant concern, with delays in new technology reaching the market due to extended regulatory pathways.
Recommendations for Laboratories and Startups:
- Engage with regulatory experts to understand compliance requirements.
- Focus on reimbursement policy reforms and advocate for favorable legislative changes.
- Prepare for potential delays and increased costs, and explore partnerships with larger institutions to navigate regulatory challenges.
The podcast concludes with a call to action for stakeholders to engage in advocacy and ensure their concerns are heard by policymakers, emphasizing the need for collaboration to navigate the regulatory landscape effectively.
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Could you go into more detail about the recommendations? For examples, labs worry how much to invest in regulation, if the whole series of FDA demands might get thrown out in court or reversed in a different 2025 presidential administration. [I had to re-ask and be sure AI was sticking to the transcript and the speakers' views.]
Recommendations from the Transcript Regarding Regulatory Investments and Uncertainty
1. Understand and Prepare for Compliance:
- Engage with Regulatory Experts: Both Jennifer Leib and Elliot Cowan emphasize the importance of labs reaching out to regulatory experts to understand the full scope of the FDA’s requirements. This includes consulting with certified Regulatory Affairs professionals to get a clear understanding of what compliance entails.
- Familiarize with Medical Device Regulations: Laboratories should gain a comprehensive understanding of medical device regulations, including requirements for registering and listing tests, medical device reporting, and implementing quality systems.
2. Evaluate Financial Implications:
- Cost Assessment: Jennifer Leib highlights the significant costs associated with compliance, estimating an average of $4.3 million per PMA submission. Labs need to evaluate these costs carefully to decide how much to invest in regulatory compliance.
- Resource Planning: With many labs being small businesses with limited revenue, it’s essential to plan for the substantial resources needed for compliance. Understanding the financial burden can help in making informed decisions about investments.
3. Monitor Legal and Political Developments:
- Stay Updated on Legal Challenges: Labs should keep a close watch on ongoing legal challenges, such as the lawsuit filed by the American Clinical Laboratory Association (ACLA). The outcome of these legal battles could significantly impact the regulatory landscape.
- Consider Political Changes: The potential for a change in administration in 2025 could lead to different regulatory priorities. Labs should be prepared for the possibility that the FDA’s rule could be modified or overturned, which adds to the uncertainty.
4. Strategic Planning for Uncertainty:
- Contingency Planning: Given the uncertainty, labs should develop contingency plans to handle different scenarios, including the rule being upheld, overturned, or modified. This involves being flexible and ready to adapt to changes in the regulatory environment.
- Focus on Compliance Steps with Immediate Impact: Labs should prioritize implementing compliance measures that have immediate requirements, such as registering and listing, and gradually work towards full compliance over the four-year phase-out period.
5. Engage in Advocacy:
- Participate in Policy Advocacy: Jennifer Leib encourages laboratories to engage in advocacy efforts to influence policy decisions. This includes participating in advocacy days and meeting with congressional offices to voice concerns and push for legislative changes that could mitigate the impact of the FDA’s rule.
- Monitor Congressional Actions: Staying informed about legislative proposals, such as the VALID Act and other related bills, can provide labs with insights into potential regulatory changes and opportunities to engage in the policymaking process.
6. Address Reimbursement Issues:
- Advocate for Reimbursement Reforms: Jennifer Leib mentions the importance of focusing on reimbursement policy reforms. Ensuring that new diagnostic tests receive appropriate coverage and payment levels is critical for the financial viability of new innovations.
7. Partner with Larger Institutions:
- Form Strategic Partnerships: Smaller labs can benefit from partnering with larger academic medical centers or national reference laboratories. These partnerships can provide the necessary resources and infrastructure to navigate the FDA regulatory process more effectively.
By following these recommendations from the transcript, laboratories can better navigate the regulatory uncertainty and make informed decisions about their investments in compliance.
