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0511 COVID LDTs
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Politics, Policy & Law

Congressional Democrats urge HHS to reverse Trump’s ban on FDA review of COVID-19 LDTs

May 11, 2021 | 8:59 PM GMT

Leaders of the House Energy & Commerce Committee are urging HHS Secretary Xavier Becerra to plug a hole the Trump administration poked in the regulatory safety net when it revoked FDA’s power to regulate laboratory developed tests for COVID-19.

E&C Chairman Rep. Frank Pallone (D-N.J.), and Reps. Anna Eshoo (D-Calif.) and Diana DeGette (D-Colo.), chairs of the health and oversight subcommittees, respectively, requested in a letter that Becerra “take steps to ensure the quality of these tests by reversing the Trump Administration’s misguided policy on LDTs and restoring FDA’s premarket review authority.”

The letter outlines the roller-coaster ride that LDT regulation has taken over the past nine months.

FDA, which has historically exercised enforcement discretion over LDTs, asserted its authority to regulate the tests in response to the declaration that COVID-19 was a public health emergency.

Overruling objections from then FDA-Commissioner Stephen Hahn and senior FDA staff, in August 2020 HHS Secretary Alex Azar barred the agency from requiring premarket review of COVID-19 LDTs. The agency retained the authority to issue emergency use authorizations (EUAs) for LDTs if manufacturers voluntarily requested reviews.

A month after Azar pulled the plug on mandatory premarket reviews, The New England Journal of Medicine published a commentary co-written by Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, that reported on flaws in COVID-19 LDTs that had been identified in FDA’s premarket reviews and described steps the agency and manufacturers took to improve the tests.

In October 2020 FDA, citing resource constraints, stated that it would no longer review voluntary EUA submissions of COVID-19 LDTs.

LDT manufacturers, however, pushed HHS to reinstate reviews because EUAs are legally required to shield manufactures from liability claims.

In November 2020, HHS directed FDA to review EUAs for LDTs within 14 days of submission, and stated that if the agency was unable to comply the reviews would be conducted by NIH’s National Cancer Institute (NCI).

In January, consulting and CDO firm NDA Partners, a subsidiary of The Planet Group (TPG), announced that it had been awarded a government contract to review COVID-19 LDTs. NDA Partners employs former FDA staff, including staff who conducted and supervised diagnostic device reviews.

Responding to the E&C letter, Julie Khani, president of the American Clinical Laboratory Association, stressed ACLA’s support for legislation.

“ACLA remains focused on working with leaders in Congress and other stakeholders to advance a modernized regulatory framework that encourages the next generation of breakthroughs and supports continued patient access to the accurate and reliable laboratory developed tests necessary for the diagnosis, monitoring and treatment of disease,” Khani told BioCentury. “Laboratories need clarity and certainty about how these critical services are regulated, and the time is now to advance meaningful comprehensive diagnostic reform legislation.”

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