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FDA’s Lab Test Power-Grab Continues

FDA’s Lab Test Power-Grab Continues
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More FDA protectionism that works against patient interests. Action Alert!

The FDA has announced its intent to issue a proposed rule this coming August that would extend the agency’s power over laboratory developed tests (LDTs). This is a critical threat, as LDTs are crucial tools used in personalized medicine because labs can create custom diagnostic tests for all sorts of health conditions. We cannot allow the FDA to stifle innovation and best medical practice (including Functional Data Analysis – the other type of FDA) in this sector and regulate these tests out of existence, as the agency has been trying to do for decades.

If the FDA is successful, your ability to get the personalized care you need from your doctor or healthcare provider will be compromised. LDTs are diagnostic tests developed and performed by local labs. They are important tools used by healthcare providers to diagnose and manage a wide range of conditions. They are widely used—thousands of different LDTs are available—and include genetic tests, heavy metal tests, tests for rare conditions, nutritional status tests, and hormone tests. They can be tailored to meet specific patient needs and can be used to respond rapidly to emerging threats like COVID-19. Currently, laboratories have the flexibility to adapt and modify tests based on evolving scientific knowledge and patient requirements. That could all change if the FDA wins.

LDTs are regulated by the Centers for Medicare and Medicaid Services (CMS). The rule hasn’t been published yet so we don’t know specifics, but what the FDA has been trying to do for years is to claim the authority to regulate LDTs as medical devices, which in many cases will mean they will require pre-market approval.

We’ve spoken to a leading laboratory that offers many crucial tests that integrative healthcare providers rely on. Without being able to talk specifics since we don’t know what the FDA’s proposed rule looks like yet, their view was that the majority of their tests would be safe from FDA scrutiny because they use standardized methodologies and are low-risk. As any new regulatory framework adopted by the FDA will likely be a tiered, risk-based approach, low-risk tests would probably not face the same scrutiny as higher-risk tests (i.e., tests that could lead to patient harm if there is an error because the test is the primary means of diagnosing a disease).

We still think there’s reason to worry about access, though, because the FDA has consistently demonstrated antipathy towards natural health and integrative medicine. The agency has, over the years, taken an adversarial stance against supplements, compounded medicines, and homeopathy, to name just a few examples. We believe this is down to the inherent conflict of interest at the agency. Drug companies, which are in competition with natural products, fund a substantial portion of the FDA’s budget. The FDA, in turn, now views the drug industry, not the public, as its client. It wouldn’t surprise us in the least if the FDA, once again, decided to attack functional tests used in the integrative community because the agency already has a history of trying to remove the tools necessary to practice forms of medicine that do not focus on prescribing pharmaceutical drugs.

Further, FDA regulation will eliminate the flexibility and adaptability of LDTs that make them such valuable tools. We saw this in stark relief during the COVID-19 pandemic. At the beginning of the pandemic, labs were held up from developing their own COVID tests because they needed to get emergency use authorization—in essence, pre-approval—to deploy their tests. This was a major missed opportunity; accurate testing is important, but the FDA prioritized red tape over getting people reasonably accurate means of testing for COVID that could have helped reduce transmission rates and hospitalizations at an earlier date. It is to all of our benefit if those developing LDTs can respond rapidly and nimbly to emerging threats, rather than be mired in FDA regulations.

If the FDA gets its way, innovation will also suffer because many laboratories may come to the decision to abandon plans to develop tests that are at risk of landing in the FDA’s crosshairs, depriving the public of new, potentially life-saving tests.

Importantly, we were able to beat back a legislative effort last year that would have allowed the FDA to regulate LDTs. The policy, known as the VALID Act, was slipped into a must-pass bill in the hope that no one would notice. Thanks to ANH members and other stakeholders, that effort failed. But the FDA’s latest announcement shows that the agency isn’t giving up, so we have to remain vigilant.

The FDA has tried before to put LDTs under its thumb. It claims to have some statutory authority over LDTs, but for decades chose not to regulate them as other diagnostic devices. LDTs have historically been regulated by the CMS. But in 2014, the FDA issued a draft guidance saying it would regulate LDTs as medical devices. Congress pushed back, with some legislators arguing that the FDA’s approach to LDTs was “redundant, [would] raise costs and stifle innovation, and [would] require additional taxpayer funding to the FDA.” The VALID Act has been reintroduced in the current Congress but is not expected to gain traction.

To us, it seemed clear that the FDA wants to take over LDTs in order to maintain the monopoly enjoyed by hospitals together with two companies: LabCorp and Quest Diagnostics (just as the agency similarly wants to eliminate compounded medicines to shore up Big Pharma monopolies). Given new authorities over LDTs, the agency would likely approve only those tests that big companies have a legal right to perform and are inclined to offer, and which insurance companies and Medicare will pay for.

Action Alert! Write to Congress and the FDA explaining why the FDA must not regulate LDTs like medical devices. Please send your message immediately.

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