ASCP Continues Push to Stop FDA’s LDT Rule as Stage 1 Compliance Approaches

The May 6 stage 1 implementation date for the U.S. Food and Drug Administration’s (FDA) final rule exercising regulatory oversight over laboratory developed tests (LDTs) is fast approaching. Despite this looming deadline, ASCP continues to press for a reprieve from the FDA’s requirements. ASCP is looking for intervention from multiple entities, including the Court, Congress, and the Trump Administration. 

ASCP recently endorsed legislation—the Freedom for Laboratory Testing and Innovation Act—that would prohibit the FDA from using any federal funds to implement the rule. In addition, ASCP has launched an Action Alert to empower our members and their colleagues to contact their congressional representatives and urge them to support this important bill. Please take part in this important initiative by using ASCP’s eAdvocacy Center here. Similarly, ASCP and almost all other pathology and laboratory medicine organizations strongly oppose the VALID Act, which would create a similar massively bureaucratic and costly oversight scheme giving the FDA oversight over LDTs. 

On February 19, oral arguments were heard in the combined lawsuits brought by the American Clinical Laboratory Association and the Association for Molecular Pathology against the FDA. ASCP filed an amicus brief with the Court opposing FDA’s oversight of LDTs. ASCP hopes to see a favorable decision by Judge Sean Jordon soon, possibly by the end of March. ASCP will report on the judge’s decision as soon as it is released.  

In addition, ASCP has written the Trump Administration requesting that it rescind the FDA’s LDT rule. Congress is still in the process of confirming President Trump’s nominees for key federal healthcare agencies, including the FDA, and the administration has not yet outlined its views on the FDA LDT rule. 

With less than two months to go before the FDA implements stage 1 of its Final Rule on LDTs, ASCP strongly recommends that labs continue working toward stage 1 compliance. ASCP will continue to follow this issue closely and will report immediately if the May 6 implementation date is delayed or suspended.