FDA Aims To Stifle Medical Innovation Again
The 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
Article from Reason.com
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