Tens of thousands of medical tests to now fall under federal oversight

The Hill ^ | 04/29/2024 | JOSEPH CHOI

[ChicagoConservative27]

The Food and Drug Administration (FDA) is revising long-standing rules to place laboratory tests under the same jurisdiction as other testing, which the agency says will help ensure better safety and efficacy.

Since 1976, the FDA has not enforced legal requirements on most laboratory developed tests (LDT) due to the Medical Device Amendments. Generally speaking, this has meant that requirements such as good manufacturing practices, premarket reviews prior to use in patients and adverse event reporting has not been enforced.

LDTs are diagnostic tests that are made and used within a single laboratory. As the FDA noted in its rule Monday, LDTs were typically manufactured in small volumes to diagnose rare diseases. At the time, the FDA’s rationale for not enforcing regulations on these tests were that they were low-risk and were employed for a small patient population.

[ChicagoConservative27]

WTF???

[FreedomPoster]

One lesson of Covid is that the FDA is in complete regulatory capture by Big Pharma. This will ultimately hurt small labs and enrich Big Pharma with no improvement for health outcomes, would be my prediction.

[ronnie raygun]

help ensure better safety and efficacy, notice they have to tell us that they have are backs and we are working for you, meanwhile they have other nefarious plans

I SAY BULLSH##

[Jane Long]

FTA ...

Common LDTs today include tests for COVID-19, blood level tests and tests for drug abuse. While LDTs in the ’70’s were carried out by laboratory personnel with expertise, current-day tests now use high-tech instrumentation and software to generate results.

“Today’s LDTs are also more commonly manufactured with instruments or other components not legally marketed for clinical use and are more often used to inform or direct critical treatment decisions, to widely screen for common diseases, to predict personal risk of developing certain diseases, and to diagnose serious medical conditions such as cancer and heart disease,” the FDA said in its final rule on LDTs.

The FDA cited these factors when announcing the change.

“LDTs are being used more widely than ever before — for use in newborn screening, to help predict a person’s risk of cancer, or aid in diagnosing heart disease and Alzheimer’s. The agency cannot stand by while Americans continue to rely on results of these tests without assurance that they work,” FDA Commissioner Robert M. Califf said in a statement.

The announcement was welcomed by health groups.

The American Cancer Society called the change “a positive step toward ensuring uniform review of all tests intended for the same purpose.”

The move also drew some blowback, however. Sen. Bill Cassidy (R-La.), ranking member of the Senate Committee on Health, Education, Labor and Pensions, blasted the decision.

“The FDA does not have the authority to unilaterally increase its regulatory jurisdiction. This rule will undermine access to essential laboratory tests, increase health care costs, and ultimately harm patients,” Cassidy said in a statement.

“During the pandemic, we saw how too much government interference and red tape delays lifesaving care to Americans. Congress needs to take action to clarify the regulatory structure for diagnostic tests.”

[BipolarBob]

All testing will now cost double what we are paying for now. Medical is impoverishing me as it is. half of the crap I have to pay for does me no good whatsoever. But it is required for my benefit.

[ConservativeMind]

I have utilized two of these tests, recently.

This is a travesty. If I want to spend my money on a new test, it is on me.

[ProtectOurFreedom]

More federalization of our lives. What part of your life does NOT have federal control these days?

[RetiredTexasVet]

Maybe they should revisit their Covid testing success!!!!!!

[Jane Long]

“The FDA does not have the authority to unilaterally increase its regulatory jurisdiction. This rule will undermine access to essential laboratory tests, increase health care costs, and ultimately harm patients,” Cassidy said in a statement.

I'm wondering what Sen Cassidy is planning to do, to reign in this out of control agency.

[metmom]

The Food and Drug Administration (FDA) is revising long-standing rules to place laboratory tests under the same jurisdiction as other testing, which the agency says will help ensure better safety and efficacy.

Sure it will.

[Trump Girl Kit Cat]

The FDA just like the entire government is USELESS and not to be trusted!!

[Big Red Badger]

Agreed...
They Have other plans.

[Sequoyah101]

Sure to make it all better. /s

Sure as hell to make it more expensive.

Bigger gooberment, it's what's good for you.

[momincombatboots]

I’ve been in the lab a very long time. Your day to day clinical diagnostic labs are not make ng their own tests. The expedient research, develop and implement are far beyond traditional labs.
However, if you do not use a manufacturers product for exactly, it n every phase, CMS may categorize it an LDT. There are a few labs that are entirely LDT, like a kit test first r hormones, other esoteric testing.

[Harmless Teddy Bear]

The Food and Drug Administration (FDA) is revising long-standing rules to place laboratory tests under the same jurisdiction as other testing, which the agency says will help ensure better safety and efficacy.

No, it won't.

But it will raise prices, require a huge increase in paperwork and mean more bureaucrats being hired with a great increase in budget.

“The bureaucracy is expanding to meet the needs of the expanding bureaucracy.”

[AFreeBird]

It always has been.

[Seruzawa]

The same FDA whose people retire and get fat paychecks from Merck and Pfizer and Eli Lily? That FDA?

As corrupt as the day is long.

[FreedomPoster]

Fair. I’m not in that space, didn’t pay attention at the beginning.

[csn vinnie]

Those tests will be as carefully reviewed as the COVID vaccines. If sufficient consideration is received, they will be certified 95% effective.

[ransomnote]

The PCR 'test' used during Covid was developed based on a 'related corona virus' and not the COvid virus, because 'isolated samples of the Covid virus were not available.'

So we went through the pandemic testing patients for a related corona virus and called it Covid. Lockdowns, exaggerated 'death reports', diagnosis and mandatory isolation in hospitals were all based on a 'test' that did not identify the presence of the Covid virus - FDA was fine with that

They have to control all information - this might be the World Health Organization's requirement for participating in their 'treaty' which would give WHO complete control of American response to the next pandemic they are planning.

Here's an example - it was the first time I came across official documentation stating that an isolated sample of the virus was unavailable' but it appears in FDA, CDC, Moderna and Pfizer documentation too. So all our future medical tests will be equally lacking in professional standards.