House Dems press Becerra on FDA LDT oversight

Regulatory NewsRegulatory News | 13 May 2021 |  By 

In a letter to Department of Health and Human Service (HHS) Secretary Xavier Becerra earlier this week, top Democrats on the House Energy and Commerce Committee pressed the health secretary to reverse a Trump-era policy that removed laboratory developed tests (LDTs), including those for COVID-19, from US Food and Drug Administration (FDA) oversight.
“Only FDA has the legal responsibility, as well as the experience and expertise, to evaluate the accuracy and reliability of diagnostic tests. In the midst of a viral pandemic, this responsibility should not be handed off to an obscure federal contractor or a different enterprise within the federal government,” write Committee Chair Frank Pallone (D-NJ), Health Subcommittee Chair Anna Eshoo (D-CA) and Oversight and Investigations Subcommittee Chair Diana DeGette (D-CO).
In August, under former HHS Secretary Alex Azar, HHS posted a brief memo to its website rescinding FDA’s guidances, compliance manuals and other informal issuances related to the premarket review of LDTs.
FDA has traditionally exercised enforcement discretion with regard to most LDTs, and the agency has asserted that the tests fall under its regulatory purview as in vitro diagnostics. In recent years, the agency has limited its oversight of LDTs to what it considers to be higher risk technologies and had included LDTs in its COVID-19 test policies, allowing certain clinical laboratories to use tests it had validated prior to EUA submission.
While HHS said that LDT developers could still voluntarily seek emergency use authorizations (EUAs), FDA announced shortly after the policy was enacted that it would no longer accept EUA requests for COVID-related LDTs. (RELATED: FDA updates COVID-19 testing FAQ, will no longer accept EUAs for LDTs, Regulatory Focus 8 October 2020).
After issuing the memo, HHS tasked the National Cancer Institute with reviewing LDTs and later contracted with a private company, NDA Partners, to assist with those reviews.
In October, the three Democrats wrote to Azar raising “serious concerns” about the move to strip FDA of its oversight of LDTs. Now, in their latest letter, the representatives question why the Trump-era policy remains in place, “despite objections from career scientists at FDA and other public health experts.”
“We therefore request that you immediately reverse the Trump Administration’s shortsighted policy and restore FDA’s premarket review authority and oversight over COVID-19 LDTs,” they write. The representatives also point to a New England Journal of Medicine article by top Center for Devices and Radiological Health (CDRH) officials reflecting on the agency’s moves earlier in the pandemic to speed the availability of tests.
“Although this approach resulted in earlier test availability, the EUA’s less-rigorous evidence standard, coupled with delayed FDA review, allowed the use of several [laboratory developed tests] LDTs that ultimately proved to have performance problems or to be poorly validated,” wrote CDRH Director Jeff Shuren and Office of In Vitro Diagnostics and Radiological Health Director Timothy Stenzel. The two noted in the article that 82 out of 125 EUA requests from clinical laboratories had design or validation issues, reinforcing the need for premarket review. (RELATED: CDRH officials reflect on COVID diagnostics approach, Regulatory Focus 9 September 2020).
Statement, Letter


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Tags: Congress, FDA, LDTs, US

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