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- House Committee Urges HHS Secretary to Restore FDA’s Authority Over LDTs
House Energy and Commerce Committee Democratic leaders urged Health and Human Services (HHS) Secretary Xavier Becerra to reverse the previous Administration’s policy to remove the Food and Drug Administration’s (FDA) premarket review requirements for COVID-19 laboratory-developed tests (LDTs). Committee members raised the regulatory uncertainty leading to liability concerns for the COVID-19 test and performance of LDTs during the pandemic.
In a May 11 letter to Secretary Becerra, House Energy, and Commerce Committee leadership Chairman Frank Pallone, Jr. (D-NJ), Health Subcommittee Chairwoman Anna G. Eshoo (D-CA), and Oversight and Investigations Chair Diana DeGette (D-CO) stated the importance of LDTs during the COVID-19 pandemic. In August 2020, the HHS announced that the FDA would no longer require premarket review of COVID-19 LDTs. Although the HHS also announced that LDT developers could continue to voluntarily seek Emergency Use Authorizations (EUA) for their tests, in October, the FDA announced that it would decline to review EUA requests for LDTs.
In response to concerns that new LDTs would no longer be eligible for liability protections under the Public Readiness and Emergency Preparedness (PREP) Act, the Trump Administration instructed the National Cancer Institute (NCI) to review LDTs in FDA’s stead.
Laboratory-developed tests remain under enforcement discretion, and the FDA is advocating for legislative action to resolve these regulatory issues. Still, the FDA is taking action on tests when needed. In May 2021, the agency took action against the GenBody antigen test.