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.
Go to top link to fill out a form to send to your representatives.
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**Comment**
Hopefully the past few years have clearly demonstrated the problem with centralized, monopolized, government sanctioned testing under the auspice of “public health” that can and will be used to take away your freedoms and rights. This faulty testing has kept people from working, going to school, and partaking in society in general.
Lyme-land has similarly been in a testing juggernaut for 40 years – clearly showing the outcome of CDC/FDA propaganda and the underlying conflicts of interest that drives everything about public health. Similarly to COVID, Lyme testing was created (and is still being used) that eliminated the most specific band for Lyme – due to vaccine development. A case definition (also still being used) was created to fit this faulty, unscientific paradigm that has ruled like an Iron Curtain ever since. Truthcures has met with the FDA in an attempt to ameliorate this but 40 years is a long time to suffer with no change.
And speaking of testing corruption: A NYC company, owned by family who donated $300K to NY governor Hochul, paid $637 MILLION to manufacture at home COVID tests without considering bids from competing manufacturers and without a contract.
The FDA has been coming after CLIA-certified labs such as IgeneX since it opened its doors. The CDC also has maligned these smaller specialized labs from the top down. Their website used to have a paragraph that called them “home-brewed” tests. I actually heard a pediatrician speak at the Wisconsin state capital who used this exact phrase. Doctors have been brain-washed that these CLIA-certified labs, which undergo far more rigorous lab requirements than Lab Corp or Quest, are quackery. The pediatrician’s statement is indicative of this propaganda process.
Ask yourself one question: why won’t doctors in mainstream medicine utilize Galaxy or IgeneX testing?
The answer is clear: they’ve been told not to. Who is telling them? The CDC/FDA and other government agencies are monopolizing medicine through the CARES Act, which in turn controls doctors like puppets. This is why people are not being treated with ivermectin, HCQ/zinc, IV vitamin C, and other known, effective treatments and why people are resorting to the court system to save their loved ones in the nick of time.
This exact scenario plays out in Lyme-land on a daily basis.
Lyme/MSIDS, similarly to COVID, has become so politicized that doctors are afraid to treat patients. Instead, they fearfully toe the CDC/FDA line by using their sanctioned tests, treatments, and guidelines – all of which are completely and utterly worthless.
Our only hope are brave, independent doctors who have chosen to step outside the corrupt, fraudulent medical monopoly to do what they started out to do: uphold the Hippocratic oath by treating patients as they see fit according to their medical training and experience, and defying the corrupt professional organizations that are in bed with the government. These doctors are being harassed, censored, and threatened at every turn but refuse to be silenced.
Madison Area Lyme Support Group 