Repeal the FDA Rule on LDTs
Please let’s all standup for patients right
Rep. Brad Finstad (R-MN) and Rep. Dan Crenshaw (R-TX) have introduced H.J. Res 145 in the House of Representatives, which would repeal the Food and Drug Administration final rule on Laboratory Developed Tests (LDTs). If the resolution passes the House of Representatives and Senate, and is signed into law, the FDA rule would be negated.
If the FDA is permitted to implement this rule, it will create a costly, dual regulatory structure that overlaps with the Centers for Medicare and Medicaid Services in overseeing LDTs. ADLM is concerned that it will stifle innovation and limit patient access to vital laboratory tests. The association continues to assert, along with many others in the healthcare community, that changes to LDT oversight should occur within the current CLIA regulatory structure.
ADLM requests that you send an email to your Representative urging them to cosponsor H.R. Res. 145, thereby supporting this effort to prevent the rule from taking effect. The type and level of LDT oversight is a decision for Congress, not the FDA. You will get a separate notice about a similar effort in the Senate. Please respond to that request as well.
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