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  • Washington Highlights

    HELP Committee Releases FDA Legislation That Includes LDT Regulation


    Len Marquez, Senior Director, Government Relations
    For Media Inquiries

    On May 17, Senate Health, Education, Labor, and Pensions (HELP) Committee Chair Patty Murray (D-Wash.) and Ranking Member Richard Burr (R-N.C.) released “discussion draft” legislation of the FDA Safety and Landmark Advancements (FDASLA) Act, which would reauthorize the FDA prescription drug, generic drug, biosimilar, and medical device user fee arrangements.

    Of particular interest to academic medical centers and their clinical labs, the legislation included a modified version of the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2022 (S. 2209), most recently introduced in June 2021. The legislation would create a new framework for the FDA to regulate laboratory developed tests (LDTs) as a new category of in vitro diagnostic called in vitro clinical tests (IVCTs) [refer to Washington Highlights, June 25, 2021]. Currently, the Centers for Medicare & Medicaid Services regulates laboratories performing LDTs, including many in academic medical centers, through the Clinical Laboratory Improvement Amendments, with state laboratory certification programs and professional accrediting bodies providing additional regulation.

    In addition to focusing on the reauthorization of the FDA’s user fee agreements and establishment of  LDT regulation, a statement issued by the HELP Committee leaders mentioned several additional provisions including efforts to:

    • Bolster oversight of cosmetics and dietary supplements.
    • Increase market competition in order to lower drug prices.
    • Expand safe disposal of opioids and other drugs with serious risks.
    • Modernize the data used to support medical product development, including alternatives to animal studies. 
    • Broaden the successful hiring authorities approved by the 21st Century Cures Act and require a Strategic Workforce Plan to help strengthen the FDA’s workforce.
    • Ensure the FDA is transparent and accountable for the user fees it accrues from industry.

    In the statement, Murray said, “Families want to know the products they entrust their health to are safe and effective—which is why this bipartisan legislation is so important. This legislation will ensure FDA has the resources it needs to do its work—and will enable the agency to finally provide serious oversight of the cosmetics and dietary supplements people in Washington state use every day.”

    Burr added, “This bipartisan draft strengthens FDA’s foundation to ensure our review and approval process is ready for the next generation of innovative products. It also includes key measurements to ensure the agency meets its commitments and modernizes our diagnostic testing framework to bring certainty to test developers and give Americans confidence in their health care decisions.”

    The HELP Committee is expected to consider the FDASLA in the coming weeks. Comments and feedback on the discussion draft are requested to be submitted by May 22; however, no official timeline has been provided for consideration of the bill.