This blog releases a new white paper on FDA's proposal to regulate laboratory-developed tests. The proposal was released September 29, 2023, and is in open comment until December 4.
My belief that this analysis is worthwhile was reinforced today when I saw that the usually-accurate Dark Report badly misquoted the FDA's proposed regulatory cost to the lab industry (as "$5B in collective new costs to industry" instead of well over $80B, with $50B up front) -- due to misdirection in the way the FDA data was written (for details, read on.)
The provided white paper by Bruce Quinn discusses the FDA's proposal to regulate laboratory-developed tests (LDTs) in the United States. It presents several key features and messages:
Overview of the FDA Proposal: The FDA introduced a comprehensive plan to regulate LDTs on September 29, 2023. The FDA proposal aims to bring LDTs under the same regulatory framework as other medical devices, including registration, reporting, and labeling requirements.
Enormous Costs: The paper emphasizes the staggering costs associated with the FDA's plan, estimating it to be around $50 billion over the first few years. This financial burden on the industry is seen as practically unattainable and far exceeding the annual profits of major diagnostic companies.
Timeline Challenges: The FDA's proposed timeline for implementation is considered unrealistic. The transition from a relatively unregulated LDT environment to full compliance with FDA regulations, including submission of 510(k) and PMA applications, within a few years is evaluated as logistically impossible.
Health Benefits: The FDA claims that its proposal will result in significant health benefits, primarily by improving the accuracy of diagnoses and reducing errors associated with LDTs. However, the paper questions the validity of these claims and suggests that they are speculative.
Legal Considerations: The paper highlights the legal controversy surrounding the FDA's authority to regulate LDTs. While the FDA asserts its legal authority, it acknowledges that this is a disputed claim, as demonstrated by the multiplex legal arguments presented in the paper.
Alternative Solutions: Instead of implementing a sweeping regulatory overhaul, the paper suggests alternative solutions achieving the same goals at far less cost. These include:
If you want to ensure the "level playing field" between labs and IVD manufacturers, and prioritize that:
1) You have the VALID Act, although I hope they can find a somewhat simpler version that might still accomplish 95% of the goals.
If you want to prioritize solving the FDA's two stated problems, LDT accuracy and LDT claims:
1) Address accuracy by requiring reviews of LDTs at roughly the current "New York State" level, and
2) Address concerns about misleading healthcare claims through far less costly means than the FDA's proposed tens of billions of dollars of regulations.
Challenges Ahead: The paper concludes that the FDA's proposal, as outlined, faces significant challenges, including industry opposition, legal disputes, and logistical hurdles. It questions the feasibility of executing the plan in its current form.
In summary, the white paper highlights the immense financial burden and practical challenges associated with the FDA's proposal to regulate LDTs. It questions the speculative health benefits cited by the FDA and suggests that more targeted and cost-effective solutions might be more appropriate. Additionally, it underscores the legal controversy surrounding the FDA's authority in this matter. Overall, the paper presents a critical analysis of the FDA's plan, raising doubts about its feasibility and potential impact.
AI Corner / Humor.
As a humorous footnote, I provide an AI-generated review of my white paper here.