The Office of the Inspector General (IG) at the Department of Health and Human Services (HHS) released a report Wednesday concluding that the Food and Drug Administration (FDA) overused Emergency Use Authorizations (EUA) during the COVID-19 pandemic.
The IG scrutinized the FDA’s adapted EUA process during the pandemic and called for it to be more closely monitored in the future. The report found that the FDA’s expanded allowances for EUA’s led to faulty COVID-19 tests reaching the market that otherwise might not have.
Meanwhile FDA still sitting on EUA applications from additional test manufacturers for nearly two years. https://t.co/mI6SRnOzO3
— Phil Kerpen (@kerpen) January 16, 2022
Early on in the COVID-19 pandemic, no tests were authorized for use by the FDA as the agency waited for the Centers for Disease Control and Prevention (CDC) to develop a test for the virus. As the CDC struggled to produce an effective test, the FDA accepted all EUA applications for COVID-19 tests to speed up the availability of the diagnostics.
According to the IG, this decision led to a “record number” of “low-quality” submissions, often from developers unfamiliar with the agency’s regulatory process. The office recommends that the FDA revise its EUA application process to account for lessons learned from the pandemic, and improve communications with developers to limit confusion. The report also states that the FDA’s need to rely on private developers rather than the CDC for a test exposed a “vulnerability.”
A number of COVID-19 therapeutics have been authorized through an EUA during the pandemic. All COVID-19 vaccines available in the U.S. were initially made available by EUA, although some have since been granted full approval for certain groups. Paxlovid, Pfizer’s antiviral pill used to treat some COVID-19 patients, is currently available under an EUA. (RELATED: FDA Refuses To Take Responsibility After Admitting It Botched Formula Crisis)
The IG report is the latest criticism levied at America’s health authorities for their performance during the pandemic. CDC Director Rochelle Walensky recently announced the agency will undergo a total restructuring due to pandemic failures.