Republicans and Democrats sharply disagree over how Congress should legislate the oversight of medical tests amid a push by the FDA to finalize regulations for some tests next month.
GOP members of the House Energy and Commerce Health Subcommittee argued on Thursday that the agency overstepped its authority by proposing that many laboratory-developed tests be regulated as medical devices. But some Democrats said the FDA effort is appropriate to ensure patients have accurate and reliable tests.
Lawmakers in both parties generally agreed that legislation would be preferable to the FDA’s proposed rule, but there was no consensus on how best to do it. Several lawmakers suggested that tweaking legislation — the Verifying Accurate Leading-edge IVCT Development Act — that failed to become law in 2022 could be a path forward.
House Energy and Commerce Chair Cathy McMorris Rodgers (R-Wash.) said the FDA’s rule would cost labs too much to be in compliance, in part because of “oppressive submission fees” that she argues would result in fewer tests offered.
But ranking member Frank Pallone (D-N.J.) said the FDA’s rule could cut down on unnecessary treatments or undertreatment due to inaccurate lab tests.
“The information that LDTs provide clinicians and patients is of grave consequence, and that is why many major cancer advocacy groups and those in the lab community welcome greater FDA oversight,” Pallone said.
Susan Van Meter, president of the American Clinical Laboratory Association, testified that the FDA rule, if finalized as proposed, would slow test innovation, create a review bottleneck at the FDA and raise legal questions.
“An exemption for academic medical centers is not the answer to these problems,” Van Meter said, referring to an idea floated in 2022 after academic medical centers opposed the VALID Act.
But Friends of Cancer Research CEO Jeff Allen, who testified at the hearing, agreed with Pallone, saying that without FDA oversight, patients may be making major medical decisions on “potentially discrepant test results.”
“It’s imperative that these tests’ performance and accuracy be well-characterized before the results are used for important treatment decisions,” Allen said. “Inaccurate or unreliable tests can have significant implications on health care cost, system burden and patient outcomes.”
VALID Act: The FDA moved forward with a proposed rule in October because a legislative effort to overhaul how all medical tests are regulated fell apart in late 2022 after McMorris Rodgers blocked the bill.
E&C Health Subcommittee ranking member Anna Eshoo (D-Calif.) said Congress needs to act and that she would support the VALID Act with some refinements.
“Congress really forced FDA’s hand to come up with their proposal,” Eshoo said. “And I think that’s a fact of life here.”
In the Senate: HELP Committee ranking member Bill Cassidy (R-La.) requested information earlier this month from industry, advocacy groups and regulators on how to improve oversight of laboratory-developed tests. But it is unclear whether there is bipartisan interest in pursuing legislation from his counterpart, Chair Bernie Sanders (I-Vt.). A spokesperson for Sanders did not immediately respond to a request for comment.
What’s next: The FDA rule to subject LDTs to greater regulatory scrutiny is under review at the White House Office of Information and Regulatory Affairs.
Several groups — including ACLA, the Children’s Hospital Association and the Center for Science in the Public Interest — are scheduled to meet with the Office of Management and Budget to discuss the rule in the coming weeks. The Biden administration is targeting an April release of the rule, according to the Fall 2023 Unified Agenda. That would shield the regulation from potentially being clawed back if Republicans control Congress next year.
Because efforts to include several health care bills in a pending spending bill fell apart over the weekend, there may be an appetite to pursue a health care package after the election in November.
But lawmakers have differing views on an appropriate approach to LDT legislation. Coalescing around a single approach remains a challenge, according to a congressional aide granted anonymity to discuss the issue.
