Wednesday, July 29, 2020

FDA Law Journal: FDA, EUA, COVID: What The Heck Happened To Us?

Passing along an article recommended in the AMP listserve.

See an open access 23-page article at Yale Law Journal Forum by Evans and Clayton - here for PDF or here for online.


It using the FDA, COVID, EUA story as a springboard to a discussion of the VALID Act, which if passed would give FDA more authority to govern LDTs.  For several years, IDSA and ASM have been prominent among voices that are uncertain about the risk/benefit of more FDA regulation in microbiology.

The abstract is:

 In response to the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) published a series of 2020 guidance documents on how to seek Emergency Use Authorizations (EUAs) for new SARS-CoV-2 tests. These guidance documents suggest EUAs are needed for laboratory-developed tests (LDTs), a type of test created and used in-house by high-complexity clinical laboratories that already are regulated by the Clinical Laboratory Improvement Amendments of 1988 (CLIA). These CLIA-regulated laboratories traditionally have provided a rapid response to emerging epidemics. Many laboratories viewed the FDA’s 2020 guidance documents as having a practical binding effect even though the FDA lacked clear statutory authority to require EUAs for LDTs developed at CLIA-compliant high-complexity laboratories. The FDA’s guidance documents led to decreased availability of testing, particularly in the early stages of the pandemic, which contributed to the catastrophic course of the COVID-19 pandemic in the United States.

This Essay concludes that the FDA lacks authority to require EUAs for COVID-related LDTs and that the FDA’s intervention, in key respects, just replicates protections CLIA already provides. The Essay then discusses recently proposed legislation, known as the VALID Act of 2020, which would expand the FDA’s authority to regulate LDTs. While spurred by longstanding concerns about tests used in genomics and precision medicine, the VALID Act’s reach is much broader and would have harmful consequences for more traditional tests, including tests for emerging communicable diseases. Before Congress acts on specific legislative proposals, a much broader, more inclusive, nuanced, and evidence-informed dialogue about diagnostic-testing policy is needed.

The conclusion is:

Setting aside debates about statutory authority, the FDA’s 2020 EUA guidances for COVID-19 testing had a practical binding effect. They subjected laboratory services to FDA oversight that may have cost time in a context where lost time meant lost lives. It will be critical to understand whether FDA’s review, which essentially duplicated the internal validation procedures laboratories already must perform under CLIA, added sufficient value to make the cost of delay and burdens on smaller labs worthwhile. It also is crucial to ask whether one-size-fits-all FDA jurisdiction to regulate all LDTs, as proposed in the VALID Act, is good policy. Genetic, genomic, and other advanced molecular diagnostic tests may raise special concerns that require tailored policy solutions. These policies, however, should be pursued without disturbing policies that have performed well for many decades for more traditional types of tests, including tests for emerging infectious diseases. Before Congress acts on specific legislative proposals, there needs to be a much broader, more inclusive, nuanced, and evidence-informed dialogue about diagnostic-testing policy.