FDA comment by BQ

Comment Tracking Number: lpr-chbf-2wux 

See attached file also. [white paper]

In comment on the FDA's proposal to regulate diagnostic tests developed by laboratories.

1.  Laboratory services as devices.

I support the comment of many stakeholders that laboratory services are profoundly different from "Devices" sold as platforms or kits.   If laboratory services nationwide had been inteded as "device" items in 1976, the budget for FDA authorities and reviews would have needed to be far larger.  That is, long before FDA explicitly excluded laboratory services as "devices," the staffing and budget must not have contemplated that they were devices, although neither had they been exempted in 1977, 1978.

2.  Benefits and risks statements are so vaguely defined that it is impossible to know the net benefit/risk equation of this proposal, nor its direction.

As many will have commented, the "benefits" are primarily dollarized survival, based on the removal of LDT risks, as much as $40B per year or $800B over 20 years (with widest error bars, even larger).   This is based on a very few citations and is a highly unstable predition.   If one tallied only "risks of chemotherapy" and not benefits, one would predict hundreds of billions of dollars of risks, suggesting we should halt chemotherapies, but with no balancing benefits, this is nonsensical.  Absent clear valuation or descriptions of benefits and risks, the policy should be suspended for clarification.

3.  The scale seems impossible.  The scale of FDA's own projections for resources are about $40B from industry over a few years, and several billion dollars for FDA- against a backdrop of FDA's global annual budget of $8B.   Using an FDA-cited figure of $300K for a fully loaded regulatory expert, the economic supplement projects numbers that would require many tens of thousands of IVD expert work-years (person years or man years) over an extremely short time period.  FDA's own numbers do not make sense with regard to feasability.  

4.  Extremely vague definition of tests excluded.  FDA excludes "1976 style tests," but this is almost like legal historicism.  Anyone working as a 40 or 50 year old lab director in 1976 is now in his/her 90s or dead.   Excluded tests are described as "fully manual" but elsewhere, FDA has classed companion diagnostic manual immunohistochemistry as PMA (e.g. Her2neu PMA P980018).  Risks are based on "indicated use" but LDT tests currently have no standardized indicated use labeling.  Without knowing the scope of inclusions and exemptions - and the present sketchy rules become more confusing, the more you know about laboratory science - the rule is not ready for public comment and further decisions.