Far from the slow churning bureaucracy many think it is, the FDA is proving that it can move at lightning speed when it comes to eliminating your health choices. Action Alert!
THE TOPLINE
- The FDA is rushing to finish a power-grab over laboratory developed tests.
- This move will remove choices and compromise patient health.
- The FDA is rushing so the next Congress does not have an opportunity to overturn the rule.
The FDA is just months away from completing its takeover of laboratory developed tests (LDTs). This 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. We believe this will compromise patient health.
What’s especially concerning is the speed at which the FDA is moving. In some areas, such as homeopathy and compounding, the agency “boils the frog slowly,” taking years to accomplish its goals lest it attract too much attention. Here we have the opposite: the FDA issued its proposed LDT rule in October 2023, receiving—thanks to all of you ANH advocates and others—over 6,000 comments. As of March 1, 2024, the agency has sent its final LDT rule to the White House for final review. Why are they in such a hurry?
It’s likely the FDA wants to get the rule done by April so it can avoid having it overturned by the next Congress under the Congressional Review Act. There is a period at the beginning of each new presidential administration during which rules issued at the end of the previous administration can be reviewed and nullified. In the current case, rules issued after May 22, 2024 would be eligible for this “look-back” review. The FDA doesn’t want to let a new Congress or a new president rescind its latest power-grab.
We at ANH-USA want to extend our heartfelt thanks to all of you who took action on this issue and posted a comment to the docket. The volume of comments this rule received was noted by several outlets covering this issue. This is one important way that we can draw attention to critical issues affecting natural health and fight for positive change.
As we’ve argued before: LDTs are crucial tools used in personalized medicine because labs can create custom diagnostic tests for all sorts of health 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 rule goes through.
You can read more about the rule in our previous coverage of this issue. It’s a familiar story: the agency wants to add a bevy of new requirements and regulations to LDTs that will make it exponentially harder for smaller labs to innovate and compete. It’s this kind of red tape that prevented the rapid distribution of COVID tests at the start of the pandemic that could have saved many lives.
Action Alert! Write to Congress and the White House and tell them to block this terrible rule. Please send your message immediately.
> It’s this kind of red tape that prevented the rapid distribution of COVID tests at the start of the pandemic that could have saved many lives.
Sad to hear ANH fall for the fake tests. They are not “tests” and would not have saved lives. PCR is a research tool created by Dr Mullis – who won a Noble prize for it. He himself said it is Not a test and Cannot diagnose disease. They can make any PCR be positive or negative depending on lab revolutions. And once they had a ‘positive’ they used deadly medical protocols on people. It’s all documented.