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E&C revives debate on lab-developed tests

Mar 18, 2024
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Illustration: Aïda Amer/Axios

The House Energy and Commerce Committee will meet on Thursday to resume the debate on regulation of lab-developed tests.

Why it matters: The FDA's statutory authority over the tests has been a major friction point and could become the object of litigation.

Catch up quick: The agency is finalizing a rule that would treat in-vitro diagnostic tests as medical devices under the Food, Drug and Cosmetic Act and phase out its current approach of not always enforcing the requirements.

  • Congress has taken up a legislative framework known as the VALID Act that would squarely set diagnostic test review and approval under FDA's authority.
  • Legislation would offer more legal certainty than a rule that could be subject to legal challenges by the testing industry and academic medical centers who oppose the effort.

Yes, but: The VALID Act was dropped from negotiations on the 2022 FDA user fee reauthorizations and the FY2023 omnibus package.

  • Energy and Commerce Chair Cathy McMorris Rodgers previously opposed the VALID Act and also called on FDA to pull its proposed rule so Congress can debate the matter.
  • Rep. Larry Bucshon previously told Axios he was pushing for aiming for a hearing that could rekindle activity on the issue before he retires at the end of this session.

What they're saying: "The proposed rule extends far beyond the scope of any legislative proposals and would threaten access to reliable tests for children and patients with rare diseases," said McMorris Rodgers and Health subcommittee Chair Brett Guthrie in a statement on the hearing.

  • "Any paradigm-shifting changes to the current regulations must come from Congress — not the executive branch."

Between the lines: American Clinical Laboratory Association president Susan Van Meter will testify at the hearing. ACLA is one of the laboratory industry groups that opposes the FDA rule and has urged for Congress to work with them on "diagnostic-specific legislation."

  • AdvaMedDx executive director Zach Rothstein is due to appear, and his group has expressed support for the VALID Act.
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