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Michigan healthcare freedom community forum
The Food and Drug Administration wants to regulate all Laboratory Developed [Medical] Tests (LDTs), also known as In Vitro Diagnostic (IVD) products. Their rule, Docket No. FDA-2023-N-2177, was published in the Federal Register on October 3, 2023. Comment period has since closed, but the rule's future is in doubt:
https://www.fda.gov/media/172557/download?attachment
https://reason.com/2024/03/28/fda-to-test-more-tests/
FDA Aims To Stifle Medical Innovation Again
After botching COVID test approvals, the Food and Drug Administration wants power over thousands of other tests.
By Ronald Bailey | April 2024The Food and Drug Administration (FDA) that massively screwed up COVID-19 testing now wants to apply its vast bureaucratic acumen to all other laboratory developed tests (LDTs). By insisting on its recondite approval procedures, the FDA at the beginning of the pandemic stymied the rollout of COVID-19 tests developed by numerous academic and private laboratories. In contrast, public health authorities in South Korea greenlighted an effective COVID-19 test just one week (and many more in the weeks following) after asking representatives from 20 private medical companies to produce such tests.
LDTs are diagnostic in vitro tests for clinical use that are designed, manufactured, and performed by individual laboratories. They can diagnose illnesses and guide treatments by detecting relevant biomarkers in saliva, blood, or tissues; the tests can identify small molecules, proteins, RNA, DNA, cells, and pathogens. For example, some assess the risks of developing Alzheimer's disease or guide the treatment of breast cancer.
The FDA now wants to regulate these tests as medical devices that must undergo premarket agency vetting before clinicians and patients are allowed to use them. The FDA estimates that between 600 and 2,400 laboratories currently offer as many as 40,000 to 160,000 tests. Overall, some 3.3 billion in vitro tests are administered to patients annually.
Out of billions of tests given, how often do laboratory developed tests appear to cause harm? In its submissions, the FDA justifies this burdensome oversight by citing problematic medical device reports and unconfirmed "allegations" for a grand total of nine and four different tests respectively between 2009 and 2023. The remaining examples cited by the FDA are tests that had actually been submitted to the agency for analysis and were subsequently rejected or revised as recommended.
A 2023 study in the American Journal of Clinical Pathology analyzed how frequently these tests were deployed in the University of Utah health system. The researchers reported that out of the more than 3 million lab tests ordered in 2021, 94 percent of them had already been approved by the FDA. Only 4 percent of the lab tests were LDTs. They believe their figures are similar across the U.S. health care landscape.
The FDA has received strong and widespread pushback from laboratories and clinicians. In a letter to the agency, American Hospital Association Executive Vice President Stacey Hughes wrote of the proposed regulations that "the unfortunate outcome likely would be the decline in the rate of clinical innovation, which would negatively impact the U.S.' ability to keep our health care system at the forefront of discovery, provide quality care to patients, and respond quickly to emerging public health risks."
The Biden administration is aiming to have the regulations finalized in April. However, MedTech Dive reports, analysts at the investment bank TD Cowen suggested that it remains "unclear if and when FDA will finalize the rule as it has faced considerable opposition and would likely be challenged in court."
Nothing succeeds in the Federal Government like repeated failure. 😡
Seriously, this is a terrible idea!
Creeping regulation limits our access to care. What's difficult about this??
FDA brings lab tests under federal oversight in bid to improve accuracy and safety
WASHINGTON (AP) — Makers of medical tests that have long escaped government oversight will have about four years to show that their new offerings deliver accurate results, under a government rule vigorously opposed by the testing industry.
The regulation finalized Monday by the Food and Drug Administration will gradually phase in oversight of new tests developed by laboratories, a multibillion-dollar industry that regulators say poses growing risks to Americans. The goal is to ensure that new tests for cancer, heart disease, COVID-19, genetic conditions and many other illnesses are safe, accurate and reliable.
“The agency cannot stand by while Americans continue to rely on results from these tests without assurance that they work,” FDA Commissioner Robert Califf told reporters on a conference call.
Califf said inaccurate tests can lead to unnecessary treatment or delays in getting proper care.
But in a significant move, the FDA decided that the tens of thousands of tests currently on the market will not have to undergo federal review. The agency said it will essentially grandfather those tests into approval to address concerns that the new rule “could lead to the widespread loss of access to beneficial” tests.
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