Advocacy - Lab Advocate
On February 21, ADLM endorsed Representative Brad Finstad’s Freedom for Laboratory Innovation and Testing Act, which would prohibit the Food and Drug Administration (FDA) from using federal funds to implement its May 6, 2024 final rule unilaterally extending the agency’s oversight to include laboratory developed tests (LDTs). ADLM has repeatedly expressed concern that the FDA rule, if enacted, would duplicate existing federal standards and harm patient care—particularly for children and those living in rural areas.
Currently, LDTs are overseen by the Centers for Medicare and Medicaid Services (CMS) under the longstanding Clinical Laboratory Improvement Amendments (CLIA) regulations. The proposed FDA rule would regulate laboratories, including hospital labs that develop LDTs, as if they were medical device manufacturers—a designation that fails to recognize the significant differences between manufacturers, who develop and sell devices broadly, and laboratories, which create tests specifically for their patients at a physician’s request.
ADLM highlighted that the Department of Health and Human Services has previously prevented the FDA from advancing this policy, and later, when Congress declined to give the agency explicit authority over LDTs in 2022, the FDA controversially fast-tracked the final rule ahead of the 2024 election. The association is concerned that if implemented, this rule will hinder the development of new LDTs - significantly increasing administrative and compliance costs and forcing labs to reduce or stop performing these essential tests.
Given that the FDA has yet to demonstrate a compelling need for such oversight, ADLM strongly supports Representative Finstad’s efforts to block the rule and preserve patient access to vital testing. The association believes that any changes to LDT oversight should take place through the established and effective regulatory framework of CLIA, ensuring that innovation in diagnostic testing continues without undue regulatory burden.
Tell your legislators to protect LDTs via ADLM’s easy online platform