Another dangerous policy has been slipped into legislation that must pass Congress by the end of September. Action Alert!
For months now, we’ve been telling you about the dangers of mandatory product registration for supplements; one key threat is that this policy has been snuck into the reauthorization of drug user fees which must be approved by the end of September. Another bad policy has been tacked on to this must-pass legislation. It represents another attempt by the FDA to extend its 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 diseases. We cannot allow the FDA to stifle innovation in this sector and regulate these tests out of existence.
LDTs are diagnostic tests developed and performed by local labs. They are widely used—thousands of different LDTs are available—and include genetic tests, tests for rare conditions, companion diagnostics, and also diseases like COVID-19.
The LDT policy that has been snuck into PDUFA is the VALID Act. It creates a risk-based framework for the FDA to regulate LDTs in which “high-risk” LDTs would undergo premarket review, whereas LDTs determined to be “low-risk” would have less scrutiny and could qualify for exemptions to premarket review. High-risk tests are those for which an inaccurate result has a high likelihood of resulting in serious harm or death to patients or is likely to delay life-supporting treatment. The policy allows FDA to revoke pre-market exemptions if new information comes to light indicating greater risks to patients. Generally, LDTs currently being offered are grandfathered in and would not need to undergo premarket review, though they would need to adhere to the bill’s other requirements.
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.
Premarket review for LDTs will also stifle innovation in an exciting medical sector. Regulators are often suspicious of new products. The agency is also more influenced by older firms offering old technology. Protecting them can also lead to lucrative jobs after leaving government. This is the old crony capitalist conundrum.
The policy comes with a litany of other requirements for LDTs. For example, the FDA can require labeling, advertising, post market surveillance, and other things it deems necessary to detect and mitigate adverse events. Like Sen. Durbin’s mandatory product listing for supplements, the policy also requires all LDTs to register with the FDA—a requirement that will pose a significant time and personnel burden on laboratories that are already stretched thin and short-staffed.
The policy also calls for the development of a user fee program whereby testing companies pay the FDA to review their tests. This is another bad idea, as it privileges large, commercial test developers over smaller labs (non-profit labs, academic labs, etc.).
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 Centers for Medicare and Medicaid Services (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.”
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. 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.
LDTs are the future of medicine. People are already able to test for and spot cancers long before they manifest themselves using current methods. These tests are improving at a rapid rate. Testing can already help prevent diabetes, heart and blood vessel illness, prostate cancer, and other diseases. LDTs are not only the future of general medicine—they are also the future of individualized medicine, which is an exciting and important development. Integrative doctors use these tests to gather information that aids them in identifying the root causes of their patients’ illnesses—this information could not be gathered and analyzed otherwise.
We cannot let the FDA regulate these tests out of existence.
Action Alert! Write to Congress and tell them to oppose the VALID Act’s inclusion in the FDA user fee reauthorization bill. Please send your message immediately.