Some lawmakers seem to suffer from long‐term memory loss. This can be worrisome—both for them and for the country. It seems like only yesterday (it was March 2020) when New York Governor Andrew Cuomo complained about the cumbersome Food and Drug Administration approval process for COVID-19 tests, pleading with federal regulators to permit the state’s Wadsworth Laboratory and private labs to perform laboratory developed tests (LDTs) without waiting for a green light from the FDA. At the time the U.S. lagged embarrassingly behind South Korea and other Asian and European countries in testing its population, as case numbers soared and hospitals were overwhelmed in the New York metropolitan area.
Fortunately, by mid‐March 2020 the FDA finally relented and allowed New York’s Department of Health to process tests by contracting with private labs whose tests had not yet received FDA approval. In fact, the FDA made regulatory changes permitting all states to use tests developed by laboratories within their borders. While late to the game, the FDA finally adopted an approach used so successfully in South Korea.
South Korea enacted a reform after its disastrous experience with the MERS pandemic. Rather than get caught flat‐footed when the next pandemic inevitably arrives, South Korea reformed regulations to allow for the rapid deployment of tests developed in private labs in a partnership in which the labs kept the regulatory agencies apprised of test safety and efficacy in real time.
In August of 2020 the Department of HHS took the FDA emergency action a step further by announcing it will no longer require FDA pre‐market approval of LDTs. A report in the National Law Review stated:
The notice clarifies that clinical laboratories that develop and offer LDTs may voluntarily seek approval, clearance, or an Emergency Use Authorization (EUA) from FDA, but that such laboratories are not required to do so. However, laboratories that chose to run LDTs for SARS‐CoV‐2 (COVID-19) without FDA premarket review or authorization will not be eligible for liability protections under the Public Readiness and Emergency Preparedness Act (PREP Act).
Yet now that case rates in the U.S. are gradually coming down and it appears the worst is behind us, lawmakers seem to have forgotten the lesson of the 2020 COVID test debacle. On May 11, 2021, majority leaders of the House Energy and Commerce Committee, its Subcommittee on Health, and the House Oversight Committee wrote Secretary of Health and Human Services Xavier Becerra asking him to rescind the August 2020 HHS policy change and return the regulatory regime to the status quo ante.
Last Spring a consensus was emerging that a rigid and inflexible regulatory regime caused unnecessary delays in getting tests, drugs, and devices, and health care practitioners to a public in need during a national health emergency. The slow and poorly coordinated response to the crisis at all levels of government provided an opportunity to comprehensively reassess the myriad laws and regulations that blocked a nimble response. Alas, it appears long‐term memory loss might leave too few lawmakers up to the task.