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  • Washington Highlights

    HELP Committee Advances FDA Legislation Proposing New LDT Regulation


    Christa Wagner, Manager, Government Relations
    For Media Inquiries

    Members of the Senate Health, Education, Labor, and Pensions (HELP) Committee debated and voted on more than 30 amendments to a manager’s amendment of the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022 (S. 4348) during a June 14 markup. The amended legislation, which would reauthorize the FDA prescription drug, generic drug, biosimilar, and medical device user fee agreements, was approved by the committee by a bipartisan vote of 13-9.

    Included in the HELP Committee-approved package was as an updated version of the Verifying Accurate Leading-edge IVCT Development (VALID) Act to create a new framework for the FDA to regulate laboratory-developed tests (LDTs) under a new category of in vitro diagnostic called in vitro clinical tests [refer to Washington Highlights, May 20]. The AAMC has repeatedly expressed serious concerns about the impact of the legislation on the practice of medicine and innovation in diagnostics and patient care at academic medical centers [refer to Washington Highlights, June 3].

    During the markup, Sen. Tommy Tuberville (R-Ala.) offered an amendment that would exempt academic medical centers from new regulations implemented through the VALID Act provisions of FDASLA (Subtitle C).

    “We have some exceptional academic medical centers in the state of Alabama. … The extraordinary patient care and cutting-edge research that these centers provide are vital to my state and have global impacts,” Tuberville said.

    “This proposed change in regulations … would create significant hurdles and unduly burdensome red tape for these medical centers, stifling innovation and flexibility, and ultimately putting patient care at risk. Exempting academic medical centers from the provision of VALID would ensure access to care is not threatened and innovation in our medical centers is protected,” Tuberville stated when debating his amendment.

    Sen. Rand Paul (R-Ky.) spoke in support of the Tuberville amendment and placed into the markup record a June 13 letter the AAMC joined as one of 100 stakeholders raising concerns about the legislation and the accelerated process for consideration of the bill. The letter was originally delivered by the HELP Committee’s May 22 deadline to receive feedback on the draft bill following its release on May 17.

    In closing the debate on the amendment, committee Chair Patty Murray (D-Wash.) acknowledged Tuberville’s interest but noted that she would move to table the amendment. “I do understand that academic medical centers are particularly focused on this policy since they do provide patient care,” Murray stated, but added her view that the language of the exemption in the amendment was “far too broad.”

    The Tuberville amendment was tabled by a vote of 12-10, with all committee Republicans except for Ranking Member Richard Burr (R-N.C.) seeking a vote on the amendment.

    Sen. Roger Marshall (R-Kan.) introduced an amendment that would require a Government Accountability Office report on the “unique considerations” for hospital-based and academic medical center laboratories in the implementation of the VALID Act provision of FDASLA. The amendment was approved by voice vote.

    Burr, an original sponsor of the VALID Act and co-author of FDASLA, noted in his opening statement, “I am deeply torn over this legislation before us today. … “[It] grants substantial new authorities to the FDA, and expands the FDA’s reach. I acknowledge that I myself have asked for the diagnostic reform bill to be included … but I worry that we are rewarding bad behavior,” Burr added, referring to recent infant formula shortages due to contamination in one manufacturing facility.

    Burr voted no on final passage of FDASLA, stating afterwards that he opposed amendments unrelated to the VALID Act that were adopted during the markup that “would kill innovation, placing the entire bill in jeopardy.”

    The House of Representatives passed its user fee package in a vote of 392-28 on June 8 without incorporation of text to create additional regulatory oversight for LDTs [see Washington Highlights, June 10]. The Senate will have to pass its companion package before the two chambers can negotiate differences and send a final bill to the president to be signed into law.