Researchers Suggest Improvements to FDA's Authorization, Approval Process Following EUA for Hydroxychloroquine

Earlier this year, the FDA granted and then revoked an Emergency Use Authorization (EUA) for hydroxychloroquine as a treatment for coronavirus disease 2019 (COVID-19) within the span of several months. This drastic change to the original EUA raised questions regarding the politicization of the FDA’s authorization process and may have increased the public’s hesitancy to trust the agency’s authorization of treatments, specifically in relation to an eventual COVID-19 vaccine.

In a viewpoint article published in JAMA, researchers proposed reforms that could improve the authorization and approval process during public health crises to increase the public’s trust in the agency. Such suggestions proved to be especially timely in light of FDA Commissioner Stephen Hahn’s recent statements regarding the plan to use the EUA process to authorize a COVID-19 vaccine and, potentially, even a full approval of COVID-19 vaccines by late 2020.

Considering the FDA’s responsibility as an organization designed to protect public health, the authors expressed concern regarding how the EUA process was handled in relation to the EUA for hydroxychloroquine.

"The FDA entered highly unchartered territory when it came to the approval and revocation of hydroxychloroquine for COVID-19, as emergency use authorizations have typically been used for diagnostics and only rarely for therapeutics. Through this piece in JAMA, we provide recommendations to help the agency make the authorization process more robust, rigorous and transparent in this pandemic environment," said co-author Herschel Nachlis, PhD, MA, research assistant professor of government and policy fellow in the Nelson A. Rockefeller Center for Public Policy and the Social Sciences at Dartmouth, in a press release.

In order to improve the accountability and transparency of drug authorizations and approvals by the FDA, the researchers suggested 4 reforms.

The first reform proposed that the FDA should clarify evidentiary standards for EUAs and create higher standards for vaccines that are produced at a larger scale. The second reform was to require the FDA to consult its existing advisory committees before issuing EUAs in the future. Additionally, meetings held to discuss such issuances could be made public with opportunities for feedback from the public.

The third suggestion was to establish extensive adverse event reporting systems, develop phase 4 trials that monitor post-approval safety and efficacy, and engage the National Vaccine Injury Compensation Program upon the granting of future authorizations.

Finally, the fourth reform suggested was to develop ongoing public education campaigns and communication tools to help explain the FDA’s regulatory decisions to the public. This suggested reform would address current concerns that have been raised by the public around the safety and trustworthiness of COVID-19 diagnostics, therapeutics, and vaccines.

"The FDA's regulatory processes are often considered the gold standard for the approval of drugs, and are fundamental to American and global public health," Nachlis said in the press release. "Our entire pharmaceutical and healthcare system depends on this standard. Maintaining credibility and public trust is integral to the FDA's ability to fulfill its mission. Now is the time for the FDA to consider ways to enhance its public support, as our nation and the world waits for effective vaccines to be quickly and safely developed, approved and deployed."

REFERENCE

Improving FDA's COVID-19 vaccine authorization and approval process: Lessons from hydroxychloroquine. Dartmouth College; August 31, 2020. sciencedaily.com/releases/2020/08/200831160804.htm. Accessed September 1, 2020.