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Is the FDA on a Dangerous Path? Overstepping LDT Authority Hampered COVID Response and Has Long Term Consequences for US Healthcare

  • Executive Chairman & CEO

As I recently discussed during my session at this year’s Executive War College, one important aspect of the COVID pandemic and laboratory testing during this time is how it exemplified the detrimental consequences of FDA overreach — which contributed in large part to testing delays and a hamstrung response in the outbreak’s early days — and how that overstepping poses risk going forward. 

On July 29, 2020 the Yale Law Review published an essay titled “Deadly Delay: The FDA’s Role in America’s COVID-Testing Debacle,” by Barbara J. Evans & Ellen Wright Clayton. This essay does a very good job of detailing the Federal Drug Administration’s (FDA) role in the extensive delays that hampered COVID testing at the start of the pandemic in the United States, which contributed to the tragic course of the uncontrolled spread of the COVID-19 virus in the United States. In addition, the essay also outlines the issues and risks should the FDA gain regulating authority over laboratory developed tests (LDTs).

The authors explain that FDA interest in oversight for LDTs appears to be grounded in its efforts to modernize approaches to genomic testing and personalized medicine. However, its one size fits all approach hamstrings traditional diagnostic testing and fails to recognize that perspectives on personalized medicine have evolved since the original concern was initially raised.

When HHS declared a public health emergency in January, it triggered the FDA’s authority to grant EUAs for medical products under Section 564 of the Food, Drug and Cosmetic Act, even though it did not grant any new powers for FDA to regulate clinical lab services. Despite this fact, FDA’s May guidance on EUAs for COVID LDTs cited Section 564 as the source of statutory authority. The guidance called for LDTs to be “validated prior to use” and to demonstrate analytical and clinical validity. Such a demand on diagnostics during an outbreak was an egregious overreach and contributed significantly to decreased testing availability and capacity. Moreover, as the essay points out, “the FDA’s intervention, in key respects, just replicates protections the Clinical Laboratory Improvement Amendments of 1988 (CLIA) already provides.”

The essay cites examples where the FDA issued orders to stop efforts, including on 2/16/2020 ordering a Seattle lab to stop developing COVID tests, and in May instructing a COVID-testing partnership between a state public health authority, academic labs, and the Gates Foundation to discontinue patient testing until proper authorization was obtained.

Further, while the FDA clearly states it does not establish enforceable responsibilities, it has the effect of being “practical[ly] binding since most laboratories lack the resources, desire, or ability to fight the FDA.”

In March of this year, Congress proposed the VALID Act (Verifiying Accurate Leading-edge Invitro Test Development) to empower FDA to regulate LDTs, traditionally regulated by CLIA. Earlier versions had been circulating in Washington for years after an abortive FDA attempt to regulate LDTs through an October 2014 draft guidance document. In 2016, the agency abandoned that draft LDT guidance amid questions about the agency’s jurisdiction to regulate laboratory services

The essay’s authors conclude that this Act, if approved in its current form, will “have harmful consequences for more traditional tests, including tests for emerging communicable diseases.”

As the essay points out, before enacting this legislation, legislators need to thoroughly review the FDA’s performance during the COVID-19 pandemic. At a minimum, review and modification of the VALID Act prior to approval are certainly needed, if not an outright rejection of the FDA’s claim to this authority. Given the existence of CLIA, which already capably performs the oversight function, and the painful example of the dangers of weakening the nation’s ability to respond to communicable disease outbreaks, this is an important and far-reaching issue. The essay summed this up perfectly, stating, “Before Congress acts on specific legislative proposals, a much broader, more inclusive, nuanced, and evidence-informed dialogue about diagnostic-testing policy is needed.”

Laboratory leaders need to fight the VALID act and voice their concerns now, while the COVID testing issues are fresh in the nation’s collective conscience.


Stay informed on COVID-19 testing, testing supply needs, and payor billing requirements by visiting our COVID-19 Laboratory Resource Center.
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