AI provides FDA LDT Comment Letter (re Poor Projections of Benefits)

 [Your Name] Bruce Quinn MD PhD Bruce Quinn Associates LLC 

[Your Address] [City, State, Zip Code] 

[Email Address] [Phone Number] [Date]

Food and Drug Administration Docket Management Staff (HFA-305) 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852

Re: Docket No. [FDA-2023-N-XXXX] - Withdrawal and Revisitation of Proposed Rule due to Flawed Cost-Benefit Analysis

Dear FDA Reviewers,

I am writing to you as Bruce Quinn MD PhD, founder of Bruce Quinn Associates LLC, to express my deep concerns regarding the cost-benefit analysis underpinning the recent FDA rule proposal detailed in Docket No. [FDA-2023-N-XXXX]. After a thorough review of the proposed rule and its accompanying economic analysis, it is my professional opinion that the rule should be withdrawn and revisited due to significant flaws in its cost-benefit evaluation.

The heart of my concern lies in the abstraction and speculative nature of the proposed rule’s benefit calculations. The estimated benefits, suggesting a value of life preserved at an annualized amount of approximately $35 billion, stand on loose extrapolations and hypothetical scenarios that are not commensurate with the tangible and direct financial costs, which exceed $50 billion over ten years, that will be incurred by the diagnostics industry. Such a comparison is unconventional and misleading.

In federal cost-benefit analyses, it is atypical and arguably inappropriate to offset intangible, imputed benefits against real cash expenditures. The lack of distinction between abstract and actual monetary values in the FDA’s documentation is problematic and far from transparent, making it difficult for stakeholders to grasp the real economic impact of the proposed regulations.

Furthermore, the analysis appears to be one-sided, considering only the "harms" of laboratory-developed tests (LDTs) without a balanced view that includes their immense value in clinical decision-making and patient care. If we were to apply a similar approach to cancer drugs—weighing only their adverse events without their life-saving benefits—we would come to the illogical conclusion that withdrawing all cancer drugs would be economically advantageous. Just as this is an absurd proposition for cancer drugs, so too is the argument to regulate LDTs based solely on their potential for harm.

The rule’s economic analysis also fails to account for the innovation and patient access that LDTs provide, particularly for rare diseases and conditions where commercial tests may not be available. LDTs often fill critical gaps in clinical care, and their regulation based on a flawed cost-benefit analysis could inadvertently stifle medical advances and reduce patient access to essential diagnostic services.

In light of these concerns, I urge the FDA to withdraw the current proposal and revisit the rule with a more balanced, transparent, and methodologically sound cost-benefit analysis. This analysis should clearly differentiate between the types of costs and benefits, and it should incorporate a full spectrum of impacts, including the positive contributions of LDTs to public health.

Thank you for your attention to this critical matter. I am available for further discussion and would welcome the opportunity to provide more detailed input.

Sincerely,

Bruce Quinn MD PhD Bruce Quinn Associates LLC