Pathways’ Pick of the Week: Scrutiny of COVID-19 Dx Regulation Escalates in DC

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ARTICLE SUMMARY:

Congress has raised more questions about FDA’s handling of COVID-19 tests in recent days, adding to an accelerating drumbeat of concern that could ultimately translate into reforms, according to our regulatory and policy editors at Market Pathways.

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Shortfalls in testing capacity have been one of if not the most persistent gaps in the US response to COVID-19. FDA has tried to respond by granting unprecedented leeway for tests to enter the market without agency review. That in turn has contributed to diminished public trust in the accuracy of test results. The net result of all this has been an ever-intensifying limelight on the diagnostics and laboratory sector.

Just in the past few days, members of Congress have on multiple occasions lodged renewed criticisms of FDA’s handling of COVID-19 testing. On July 13, Democratic leaders of the House Energy and Commerce Committee penned a letter to FDA Commissioner Stephen Hahn questioning the agency’s follow-up on the performance and safety of tests that have been allowed on the market with reduced emergency data requirements.

“While no diagnostic test will ever be 100 percent accurate, these lower standards for determining reliability in diagnostic tests could affect our understanding of COVID-19’s spread within a community and across the United States,” the representatives wrote. The letter specifically calls out performance issues raised by FDA and others with Abbott Laboratories Inc.’s rapid ID NOW COVID-19 point-of-care diagnostic. The letter also targeted FDA’s shifting policy on serological antibody tests for COVID-19—starting with the unprecedented policy initiated in March allowing companies and labs to sell antibody tests with no Emergency Use Authorization, followed by a backtrack in May mandating EUA submissions within a 10-day window for commercial test makers. The lawmakers want FDA to clarify how it is ensuring unauthorized tests are removed from the market, how it is monitoring performance of EUA tests, and what enforcement actions FDA may direct at firms that don’t comply with agency expectations, including requests for postmarket data follow-up. They expect a response from FDA by July 27.

The letter comes several days after the House Appropriations Committee approved the fiscal year 2021 funding bill that includes FDA dollars. The standard committee report accompanying the legislation includes a section on “COVID-19 Response” that exclusively focuses on deficits in FDA’s handling of testing. The report calls for FDA to contract with an independent entity to perform a comprehensive assessment of the testing response. The Appropriations Committee cites the shifting antibody test policies, but it also calls back to earlier criticisms of the agency for not supporting a rapid enough roll-out of SARS-CoV-2 diagnostics and putting too much stock in the Centers for Disease Control & Prevention assay at the expense of other tests. (FDA, for its part, has critiqued the CDC for not providing viral samples to commercial test developers soon enough.)

“FDA’s efforts were narrowly focused on a single diagnostic test, resulting in unfortunate delays to engaging and fully utilizing the nation’s existing testing capabilities,” the appropriations report notes. The lawmakers acknowledge “how difficult it is to judge the balance between speed and accuracy, and which is the most appropriate response at any given time.” But the current situation makes it clear that more introspection is needed on the proper balance, they note.

The independent assessment requested in the Appropriations report language may or may not ultimately happen. And what exactly will come out the Energy and Commerce request remains to be seen. But these actions add to an already accelerating drumbeat of focus and fact-finding in the diagnostics regulatory space. That increases the chances that longer term reforms will come out of all of this, both for emergency and non-emergency policies for overseeing diagnostics.

That is especially the case because reform momentum was already growing prior to the pandemic. The much-awaited VALID Act was introduced just as the emergency was surfacing . (See “Reform in the Time of Coronavirus? Diagnostics Bill Surfaces as Pandemic Escalates,”Market Pathways,March 24, 2020.) Part of the underlying goal of that legislation is to address the incongruities between what is faced on the regulatory front by IVD test-kit makers on the one hand, and clinical laboratories that develop tests on the other. That remains an area of inconsistency during the pandemic. For instance, while commercial antibody test developers must now submit for an EUA within 10 days of notifying FDA, high-complexity laboratories are not required to seek an EUA for such tests under current policy. 

The post-mortem on what the COVID-19 emergency and regulatory reaction says about possible diagnostics regulatory reforms will certainly be interesting. But we are not at that stage yet. While there have been some concerns in the medtech community recently that the Trump administration might let the official federal COVID-19 emergency declaration expire later this month, that seems unlikely. For one, FDA’s recently issued policy outlining the regulatory path to a COVID-19 vaccine expressly leverages the leeway granted by the continued presence of the declaration. And, more to the point here, FDA is likely going to continue to need emergency authorities for the ever-ongoing ramp-up in testing that is still needed to support diagnosis and surveillance. The era of emergency decision-making is not ending soon, and neither are the new questions it can raise about proper regulatory balance.


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