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Diagnostic test debate returns with FDA rule near

Mar 21, 2024
Illustration of a stopwatch with a test tube instead of a second hand.

Illustration: Gabriella Turrisi/Axios

The VALID Act and the regulation of diagnostic tests resurfaced at a House Energy and Commerce hearing today that coincided with the FDA finalizing a rule that would give it oversight for four years.

The big picture: Trade groups mostly supported Congress taking action on oversight of the tests, with some explicitly endorsing the VALID Act's risk-based approach for FDA regulation of diagnostics that come from commercial makers or a single lab.

Driving the news: E&C Chair Cathy McMorris Rodgers called on the FDA to rescind the rule, mostly because of the way she said it would quash innovation and the development of novel tests like one for xylazine, a sedative that's increasingly mixed with illicit fentanyl.

  • McMorris Rodgers has also opposed the VALID Act and told Axios today that she hasn't decided whether to push her own legislation.

On the Senate side, HELP Committee Ranking Member Bill Cassidy sent out an RFI on a regulatory framework for diagnostics this month, which signals that he's also interested in taking up the issue.

  • Cassidy has previously said that he opposes the FDA rule and also wants Congress to take action, though he doesn't seem to be a fan of the VALID Act, either.

State of play: The FDA rule is likely to be finalized in April, providing some regulatory certainty around tests for cancers, pathogens and rare diseases.

  • Analysts believe it's likely to be challenged by the clinical lab industry in court, kicking off a process that could take three or four years to unwind.

What they're saying: E&C health subcommittee Ranking Member Anna Eshoo asked each hearing witness to say whether they supported the FDA rule or the VALID Act, which she backs.

  • American Clinical Laboratory Association president Susan Van Meter hedged and said that she supported "comprehensive legislation," and that there were "positive attributes to the VALID Act."
  • Zach Rothstein of AdvaMedDx, Donald Karcher, president of the College of American Pathologists, and Jeff Allen, president of the Friends of Cancer Research, all said they supported the VALID Act.
  • Meanwhile, Dara Aisner, the representative of the Academic Coalition for Effective Laboratory Developed Tests, which represents some academic medical centers, opposed the legislation.
  • She said her group "supports a middle ground" such as a "pathway that asks laboratories to undergo proficiency testing."

Flashback: Clarifying the FDA's authority over the tests has been a friction point for years, with legislative language proposed and then dropped from multiple packages.

  • Industry groups are clearly split over the matter, but it remains to be seen whether the rule being finalized will finally spur Congress to action.
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