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0113 LDT Reg
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Regulation

After pushing FDA out of and back into COVID-19 LDT review, HHS turns to outsourcing

Jan 14, 2021 | 12:43 AM GMT

HHS is dealing with the fallout of its deregulatory push for COVID-19 lab tests by leaning on ex-FDA consultants for EUA reviews.

The consulting and CDO firm NDA Partners, a subsidiary of The Planet Group (TPG), announced Tuesday it had been awarded a government contract to conduct reviews of laboratory developed tests (LDTs) to detect COVID-19, including tests that also detect other respiratory pathogens.

NDA Partners is one of several consulting firms staffed with former senior FDA officials. Its roster includes David Feigal, former director of FDA's Center for Devices and Radiological Health (CDRH), and Alberto Gutierrez, former director of the Office of In Vitro Diagnostics and Radiological Health at CDRH.

The exceptional decision to turn to private sector consultants, and for HHS to take control over an FDA role, comes after HHS revoked FDA’s authority over the tests in August, then reinstated and mandated it in November.

The authority was removed as part of a long-running conflict between deregulatory advocates and venture-backed labs that have pushed to eliminate FDA oversight, versus public health advocates who believe the agency plays an essential role in ensuring the safety and reliability of LDTs. The Trump administration then brought FDA back into the process after labs complained that removing FDA authorization strips them of liability protections granted to biodefense countermeasures.

According to an FDA source who did not want to be identified, CDRH Director Jeffrey Shuren resisted HHS calls for FDA to review COVID-19 LDT Emergency Use Authorization applications that are submitted on a voluntary basis because CDRH lacks sufficient resources to conduct the reviews.

The saga continues

LDTs, which are developed and conducted by a single CLIA-certified laboratory, typically do not require FDA review. But the state of emergency declared for the pandemic in January gave FDA oversight over LDTs for COVID-19 via the EUA process, with the logic that inaccurate tests present a greater risk during a public health emergency.

On Aug. 19, HHS posted a notice on its website saying FDA can no longer require premarket review of LDTs for COVID-19 unless it goes through a formal rulemaking process, citing consistency with deregulatory executive orders issued by the president.

Although the HHS policy left room for labs to voluntarily seek review, on Oct. 7 FDA announced it would decline to review LDTs “to make the best use of our resources for the greatest public health benefit.”

Because the Public Health and Emergency Preparedness Act (PREP Act) only grants labs immunity from claims of loss if the test in question has an EUA, HHS later reversed course.

On Nov. 16, the department directed FDA to review EUA applications for LDTs within 14 days of submission; if the agency could not complete a review in time, it would then be conducted by NIH’s National Cancer Institute (NCI).

The Jan. 12 announcement that NDA Partners is picking up the mantle of LDT review for COVID-19 suggests that strategy ran into capacity constraints at FDA and NCI, which is taking the lead on review of serology tests for antibodies against SARS-CoV-2.

NDA Partners, in collaboration with fellow TPG subsidiary Treximo, will provide reviews of EUAs for COVID-19 LDTs, and written assessments of those applications that will inform the final evaluations and regulatory decisions made by HHS’s Office of the Assistant Secretary for Health (OASH).

The firm’s Gutierrez and Feigal will also provide strategic guidance to OASH on the LDT review program’s goals and processes. 

As with other 11th hour Trump administration policies, it is possible that the Biden administration will reverse the revocation of FDA’s authority over LDTs, as well as the decision to outsource LDT EUA reviews.

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