Is FDA Oversight of LDTs Likely Soon?

The U.S. Senate Health, Education, Labor and Pensions (HELP) Committee just concluded two hearings about reauthorizing the Medical Device User Fee Amendments. The amendments, also known as MDUFA, set the fees paid by medical devices manufacturers to get their products, such as laboratory diagnostics, approved by U.S. Food and Drug Administration (FDA). 

During these hearings, the Committee was urged to significantly increase the FDA’s authority over laboratory developed tests (LDTs). These are tests that have been developed, or modified, within clinical laboratories. Panelists who testified on MDUFA urged the HELP Committee to incorporate the Verifying Accurate Leading-edge IVCT Development (VALID) Act into MDUFA. This would likely prevent Congress from making any significant changes to the VALID Act. (MDUFA is considered “must pass” legislation and any changes to this legislation could complicate its approval by Congress.) 

Concern about the VALID Act seems increasingly probable—and worrisome—for supporters of LDTs. The VALID Act would give FDA oversight over LDTs. The legislation could subject these tests to the same regulatory requirements as commercial diagnostics, including pre-market approval—a possibility that could significantly complicate the ability of clinical laboratories to create innovative and timely diagnostics for their patients. Concerned about this prospect, ASCP joined with the American Medical Association and other medical societies to raise concern about this possibility. Due to ongoing concern about this possible outcome, ASCP has released an Action Alert urging our members to ask Congress to keep the VALID Act out of MDUFA. The VALID Act is a complex piece of legislation with significant ramifications for clinical laboratories and it requires thoughtful consideration that is separated from the political needs to fund FDA. 

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