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March 17, 2025

Legislation to Prevent the Overregulation of Laboratory Developed Tests Introduced

By America's Blood Centers

Reps. Brad Finstad (R-Minn.) and Dan Crenshaw (R-Texas) have introduced legislation to stop the overregulation of laboratory developed tests. H.R. 1463, the Freedom for Laboratory Innovation and Testing Act. The legislation would, β€œprevent any federal funding from being used to implement the Biden Administration’s burdensome U.S. Food and Drug Administration’s (FDA) rule that inhibits the innovation of and delays access to Laboratory Developed Tests (LDTs),” according to a news release.

The congressmen explained that the overregulation of laboratory developed tests proposed in the FDA’s LDT rule would:

  • β€œ[i]mpose regulatory burdens that hinder the development and deployment of new and improved lab-developed tests;
  • [i]ncrease regulatory requirements that will lead to delays in patients’ access to critical diagnostic tests;
  • [p]otentially hinder collaborative efforts in clinical care that rely on the flexibility provided by LDTs; and,
  • [n]egatively impact small and medium-sized laboratories, which will face economic challenges with complying with the rule as written.”

Preventing the overregulation of laboratory developed tests by exempting blood center LDTs from diagnostic regulation reforms is a priority of America’s Blood Centers’ (ABC) 2025 Advocacy Agenda. ABC has sent a letter of support for the legislation, that would prevent the overregulation of laboratory developed tests, explaining that blood centers have developed and use LDTs and that, β€œ[t]he quality and validity of these tests are already ensured by a comprehensive regulatory framework including compliance with extensive FDA regulatory requirements, state specific requirements, and accreditation standards. Yet, despite these safeguards, in May 2024, the FDA issued a final rule subjecting in vitro diagnostic products (IVDs) to additional regulatory burden. The current regulatory framework already includes a multi-layered approach providing rigorous oversight and regular inspections. The additional FDA regulations are redundant burdens on blood centers without providing any increase in patient safety. Indeed, these regulatory burdens will likely hinder patient care by introducing unnecessary delays and reduced availability of needed tests.” ABC previously submitted comments in April 2024 responding to a request for information (RFI) for reforms to diagnostics regulation from Sen. Bill Cassidy, MD (R-La.), ranking member of the Senate Committee on Health, Education, Labor, and Pensions (HELP) that called attention to the potential impact of overregulation of laboratory developed tests. The FDA’s five stage phaseout policy will take place over a four-year period and is set begin on May 6th. We encourage members to also send a letter to your Representative asking them to support H.R. 1463. ABC has developed a one-pager to assist you in your advocacy efforts. Rep. Finstad previously introduced a resolution to repeal the FDA’s LDTs rule.

SUBSCRIBE TO THE ABC NEWSLETTER FOR THESE STORIES AND MORE.

Posted in ABC Newsletter
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      • Modernizing the Licensure Process
      • Exempt Blood Center LDTs from Diagnostic Regulation Reforms
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