FDA seeks ‘legislative solution’ for LDT oversight

Regulatory NewsRegulatory News | 24 February 2022 |  By 

In the wake of a New York Times investigation into non-invasive prenatal testing (NIPT), the US Food and Drug Administration (FDA) told Republican lawmakers that it would welcome legislation to enable greater oversight of NIPTs and other laboratory developed tests (LDTs).
The Times investigation, published early last month, found that some NIPTs that screen for microdeletions that are offered to hundreds of thousands of pregnant women each year frequently give false positive results when screening for rare genetic conditions such as Wolf-Hirschhorn syndrome and Prader-Willi syndrome. While follow-up testing is recommended to confirm positive results, it is often expensive and invasive, and may not be feasible until later during pregnancy. According to the Times, some patients sought abortions after receiving results from such tests, and many described their experience as “agonizing.”
A report from the Pew Charitable Trusts released last October similarly raised concerns about the insufficient FDA oversight and a lack of transparency surrounding LDTs. The report called on Congress to pass legislation to enable FDA review of higher-risk LDTs and require registration and adverse event reporting for all LDTs on the market.
Citing the Times report, nearly 100 Republicans wrote to FDA demanding answers to more than a dozen questions about the agency’s awareness and oversight of the tests discussed in the article.
“The Food and Drug Administration … shares your concerns with the patients’ experiences described in this article,” Andrew Tantillo, acting associate commissioner for legislative affairs at FDA, wrote in the agency’s response to the lawmakers, which Focus has reviewed.
Tantillo cited FDA’s longstanding concerns with laboratory developed tests (LDTs) and its multiple attempts at bringing them “under active oversight since the 1990s,” including its recent stalled effort in the mid-2010s. (RELATED: FDA delays finalization of lab-developed test draft guidance, Regulatory Focus 18 November 2016)
Most LDTs do not undergo premarket review by FDA. While the agency has asserted that these tests fall under its regulatory purview as in vitro diagnostics, it has limited its oversight to what it considers to be higher-risk technologies under a paradigm that has existed since the Medical Device Amendments were passed in the 1970s. More recently, FDA has argued that many LDTs, have grown more complex and are used for higher-risk indications than in decades past.
“Since 2016, FDA has engaged with Congress on legislative efforts to create a modern oversight framework for all in vitro clinical tests, regardless of where they are made,” Tantillo wrote in his letter to the Republican lawmakers.
He cited the agency’s recent “technical assistance” on the Verifying Accurate and Leading-Edge In Vitro Clinical Test Development Act (VALID Act), adding that the approach laid out in the bill is supported by patients, test makers and laboratory developers.
“HHS and FDA support the establishment of modern authorities and tools to ensure that tests are accurate and reliable, regardless of where they are made. We are committed to continuing to work with Congress on a legislative solution and look forward to further engaging with you and your staff on the issue,” Tantillo wrote.
Speaking at a Friends of Cancer Research event on Tuesday, the sponsors of the VALID Act, Reps. Diana DeGette (D-CO) and Larry Bucshon (R-IN), championed their bill. (RELATED: FOCR calls for flexibility in review of companion diagnostics for rare biomarkers, Regulatory Focus 24 February 2022)
“The VALID Act … would establish a framework within the FDA to regulate diagnostic tests and it would give the agency the tools necessary to ensure that those tests are both safe and effective,” DeGette said.
While the act has not seen any action in committee, Bucshon said he’s eying any opportunity to advance it, including hitching it onto the must-pass user fee legislation this year.
“Representative DeGette and I continue to work with stakeholders, the FDA and committee leadership on a path forward. I’m working all the angles, as is Diana, to call on the committee for hearings on the VALID Act and advance the bill – whether on its own or attached to must-pass bills like MDUFA, which is coming up this year,” Bucshon said. “The time for Congress to clarify the rules of the road for diagnostic testing is now.”


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