A new proposal from the FDA will compromise your ability to get the personalized medical care you need. Action Alert!
We reported a few months ago that the FDA was planning to propose a new rule to extend its power over laboratory developed tests (LDTs). That proposal was published last week, and, in line with our concerns, it represents a major attack on LDTs that we think will compromise patient health. We cannot allow the agency to regulate these critical tests out of existence. Use the forms below to post an official comment to the public docket.
This rule is the culmination of many years of effort from the FDA to extend its power over LDTs. Like previous attempts, what the FDA is trying to do is regulate LDTs like other medical devices, which means a boatload of additional regulatory requirements and, in many cases, premarket review.
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. 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 this proposed rule goes through.
Over the years, the FDA has tried every trick in the book to get this done. About a decade ago, the agency issued a guidance document take control over LDTs. Congress pushed back, and eventually the FDA withdrew the guidance. During this time, Representative Michael Burgess (R-TX) said in a statement that the FDA’s regulatory approach to LDTs is “redundant, will stifle innovation, and will require additional taxpayer funding for the FDA.”
Then, last year, a legislative proposal that would have extended the FDA’s power over LDTs was snuck into to a piece of must-pass legislation but was luckily not part of the final bill.
If the FDA is successful, all LDTs will be subject to a bevy of new regulatory requirements, including quality system regulations, medical device reporting, registration, listing, and new labeling requirements—not to mention premarket notification and premarket approval that will apply to many tests.
Premarket review for these tests is a big mistake. 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.
The imposition of these new regulations, particularly premarket review, make it exponentially more difficult for independent labs to bring new tests to market or modify existing tests to meet emerging public health needs. In our view, this is intentional: it seems 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. 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.
As we reported previously, we’ve spoken to a leading laboratory that offers many crucial tests that integrative healthcare providers rely on. 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 such, these tests would likely not have to go through premarket approval, but would need to comply with the other regulations that pertain to medical devices.
If we are able to assess our health status properly and to intervene early before serious disease manifests, we need access to a diverse range of tests offered by independent labs. We cannot let the FDA regulate these tests out of existence.
Action Alert! Post a comment to the public docket opposing the FDA’s LDT power-grab. Please send your message immediately.