More Transparency Needed for COVID-19 Emergency Authorizations | Regulatory Agencies | JAMA | JAMA Network
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Health Agencies Update
December 22/29, 2020

More Transparency Needed for COVID-19 Emergency Authorizations

JAMA. 2020;324(24):2475. doi:10.1001/jama.2020.24201

To improve public trust, the US Food and Drug Administration (FDA) should be more transparent in publicly disclosing its reviews of safety and effectiveness data leading to Emergency Use Authorization (EUA) of coronavirus disease 2019 (COVID-19) vaccines and treatments, according to a recent report from the US Government Accountability Office (GAO).

Disclosing more safety and effectiveness data could help the US Food and Drug Administration improve public trust in novel coronavirus vaccines and treatments, according to a recent report.

Ted S. Warren/AP Images

In compiling its report, the GAO reviewed federal laws and documents and interviewed officials from the FDA, a public health association, and 9 organizations representing a broad range of frontline health care professionals who are responding to the COVID-19 pandemic.

The FDA issued a guidance in January 2017 regarding its general recommendations and procedures applicable to all EUAs. It noted that the type and amount of data needed to support an EUA may vary widely, considering that authorization could be granted for many different kinds of medical products. Instead of specifying the minimum number or types of studies required, the guidance stated that it would assess effectiveness data and risk-benefit profiles on a case-by-case basis.

As of mid-November, the FDA had issued 4 EUAs for COVID-19 therapeutics, including 1 for a new use of chloroquine and hydroxychloroquine that it eventually revoked. The other 3 were for remdesivir, convalescent plasma, and bamlanivimab, a monoclonal antibody.

The agency issued a guidance in October 2020 to inform companies working on COVID-19 vaccines about what information is needed to support an EUA. On November 20, Pfizer and BioNTech submitted the first EUA request for a COVID-19 vaccine.

Although the FDA explains its EUA decisions in publicly available authorization letters and other supporting documents, it has not uniformly released information from its scientific reviews of each therapeutic’s safety and effectiveness data, the GAO noted.

“We understand the FDA’s reported constraints,” the report noted. “However, in light of the gravity of the pandemic and the need for a high degree of public confidence in FDA’s decisions, the agency should identify ways to uniformly disclose the information” as it does for approved drugs and biologics.

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