FDA Holds Public Workshop on Regulatory Oversight of Laboratory-Developed Tests (Part II)

The FDA’s public workshop on their draft guidance framework for the regulation of laboratory-developed tests (LDTs) continued yesterday, featuring sessions on three additional issues: 1) notification and adverse event reporting, 2) public procedures for classification and prioritization, and 3) quality system regulation.

Many issues that had been raised during Thursday’s sessions reappeared in the context of these new subjects.  Commenters considered whether and when laboratories should be able to submit one (rather than many) LDT notifications and/or registrations, the relationship between clinical use and risk classification, and the need to be sensitive to the diversity of LDTs and their providers in formulating the final guidelines.  Other, more legal aspects were also raised again, including concerns about redundancy between FDA regulations and those already promulgated by the Centers for Medicare & Medicaid Services under the Clinical Laboratory Improvement Amendments, whether the FDA possesses the legal authority to regulate most LDTs, and whether the FDA is required to proceed by notice-and-comment rulemaking rather than acting through the guidance process.  (Litigation is almost certain to arise on these last two topics, about which I’ll have more to say in future posts.)

But I want to briefly highlight one theme that cropped up on both days more frequently than I had anticipated: the role of insurers and insurance reimbursement.  Panelists considered whether insurers or other payers should have a seat at the table when advisory committees are convened to classify and prioritize LDTs for review.  They discussed the effect of FDA approval on insurance coverage, debating whether the proposed regulations would increase or decrease access to FDA-approved LDTs.  But most importantly (at least in my view), they explicitly considered the way in which increased FDA regulation would combine with decreasing insurance reimbursement to decrease incentives for innovation in diagnostic testing.

I’ve thought about this last question a lot, because I happen to be writing a paper about this very problem.  Essentially, over the last five years the incentives to invest in diagnostic technologies have been severely damaged.  It is becoming more expensive to develop diagnostics (because of the FDA’s proposed requirements), more difficult to protect diagnostic technologies with patents (due to Federal Circuit and Supreme Court opinions), and more difficult to recoup investments into diagnostic testing (as Congress has cut reimbursement rates).  Each of these developments on its own may be salutary (in keeping with this blog post, I’ve written previously about several potential benefits of the FDA’s proposed regulations), but together they threaten the ability of scientists to create and develop badly needed diagnostic tests.  Fortunately, just as each legal system has contributed to the problem, each system can also be used to solve it, and there are particular legal interventions that might be leveraged to restore an appropriate balance in incentives to innovate in diagnostic technologies.  As it relates to LDTs, the point here is not that companies are wrong to worry about the effects of the FDA’s proposal on innovation.  It’s instead that the FDA is not alone in its ability to affect innovation incentives, and it’s not solely the FDA’s responsibility to address these issues.  This is a complicated issue, and I look forward to seeing how the FDA decides to proceed.

One thought to “FDA Holds Public Workshop on Regulatory Oversight of Laboratory-Developed Tests (Part II)”

  1. The Elephant in the room is where the tests with the highest risk fit in. The ASAM plans to use tests developed as forensic LDTs on almost all of us according to the ASAM White Paper. The tests Robert Dupont mentions here before the DAATIA


    The consequences of a false forensic test can be far-reaching, grave and permanent. The majority of drug and alcohol testing requires FDA approved testing, strict chain-of-custody and MRO review. Specificity is the most critical component and prohibit false-positives. They should be close to nonexistent as the Federal Workplace guidelines attempt.

    But in 2003 a group introduced the first “forensic” LDT, EtG, by pitching a minor metabolite discovered in the 1950s to NMS labs. No FDA approval requirement means no FDA oversight and since this time the ASAM has introduced an array of nail, hair, breath, urine and blood tests via the LDT route and using them for monitoring groups with little to no power (criminal justice, professional monitoring programs, etc.). I encourage you to read the ASAM White Paper on Drug Testing as it describes the use of these tests in virtually everyone. The ASAM proposes random suspicion-less drug and alcohol testing using these LDTs with no evidence base by using the doctor-patient relationship as a loophole to bypass MRO review and chain of custody as safeguards. The loophole is the Doctor-patient relationship which renders it “clinical” with the results being “assessment” and “treatment. Any assessment will be done at an “approved treatment facility” meaning ASAM 12-step facility. With the new DSM-5 low bar criteria for substance use disorder (SUD) which they lobbied for there is a high likelihood of that diagnosis being given. And part of the treatment will be more drug testing and lifelong abstinence with 12-step recovery.

    The ASAM white paper can be seen here:


    And the accountability and integrity of both the labs and those who are using (and introduce) these tests can be seen below. The attached documents show top down corruption at both a collecting lab (Quest) and a forensic drug testing lab (USDTL) and the ordering agency (PHS, inc.) The documents comprehensively show from collection to analysis and subsequent coverup the corruption involved in LDT forensic testing. Here Quest collected an ostensibly “forensic” specimen and, at the request of PHS, changed it to a “clinical” specimen to bypass chain of custody and sent it to USDTL with instructions to process and report it clinically. Quest kept it for a week under unknown conditions and sent the then fermented sample to USDTL. After obtaining the positive “clinical” specimen PHS sends a faxed request to change it back to “forensic” by adding a chain of custody and adding back the forensic iD # as unique identifier. They then report it as a positive. These documents need to be used to show the reality of LDT testing and how easily it is misused, the top-down corruption and corporate psychopathy of these groups. And if you do a public policy analysis of the ASAM you will find that their positions are inevitably accepted. The White paper will come to fruition unless we stop it as it is being done through sub-government methods well funded by the DAATIA and other special influence groups who have infiltrated regulatory medicine.–Michael Langan, M.D.


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