Is There a Bi-Partisan Push for FDA To Regulate LDTs?
(Thursday, March 3, 2022)
A group of Republican Congressmen wrote to FDA last month raising concerns about LDTs for prenatal genetic testing and as expected, FDA wrote back asking them to pass laws to regulate LDTs. FDA’s answer is a repeat of what it has said for the last decade or more, that it wants to regulate these diagnostic tests, but it is hampered by lack of laws allowing it to. Lab Developed Tests (LDTs) are intended to allow patient access to specialized tests developed by individual labs. These tests can be offered only by prescription and are not intended to be mass marketed. Since these tests involve physician intervention, the expectation is that the physicians prescribing these tests would educate themselves about the utility and validity of these tests and use them in conjunction with other diagnosis. However, over the last two decades, LDTs have become much widely used than originally expected and have become commonly used as the sole tool for diagnosing increasingly complex indications. The fact that these tests are prominently used for diagnosis of genetic diseases in fetuses, a test presumably used to decide if or not to abort a fetus with probably life-threatening genetic diseases, brought these to the attention of the conservative politicians. But prenatal testing is just the tip of the iceberg. There are thousands of LDTs, for diagnosing practically all kinds of indications, available to the patients. In the past, the conservative politicians blocked any new regulation for LDTs. The last time FDA proposed serious regulations for LDTs was in 2016, when FDA proposed a tiered approach to regulate such tests. However, those rules were shelved due to the politics of the times. The last administration not only discouraged regulation of LDTs, but it also even forced FDA to withdraw any policies regulating LDTs. However, does the letter last week, signed by about 100 conservative Congressmen and Congresswomen, mean that FDA may have found an unlikely partner in its desire to regulate LDTs? Should be finally expect a new law creating a pathway to formal approval of LDTs like other IVDs? It is too early to say. It could be just politics as usual. For now, prenatal genetic testing and thousands of other unregulated LDTs, continue.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC