Experts draw lessons from FDA's hydroxychloroquine EUA controversy

By Leah Sherwood, The Science Advisory Board assistant editor

September 7, 2020 -- Public health and regulatory experts advocated for changes to the U.S. Food and Drug Administration (FDA) emergency use authorization (EUA) process in a viewpoint published online August 31 in the Journal of the American Medical Association. They offer a set of recommendations to improve the process going forward as more COVID-19 vaccines and treatments emerge.

The authors focused on the FDA's controversial EUA for the antiviral drug hydroxychloroquine. The FDA granted an EUA for hydroxychloroquine on March 28, 2020, and then revoked it less than 12 weeks later on June 15, 2020, after a number of studies failed to find positive effects from the drug.

This swift authorization and revocation were problematic for three reasons, according to the authors. First, such rapid approval of an unvetted treatment could have major public health consequences. Second, it appears that the FDA's rapid approval was influenced by politics and external pressure by nonmedical experts on the federal agency. Finally, the episode contributed to the erosion of the FDA's reputation and public trust. These issues are of continued importance as the FDA will soon consider using the EUA process to authorize COVID-19 vaccines prior to full approval later this year.

"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," explained co-author Herschel Nachlis, PhD, an assistant professor of government and policy fellow in the Nelson A. Rockefeller Center for Public Policy and the Social Sciences at Dartmouth. "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."

In the article, the authors recommended four improvements to the FDA's EUA process. First, in order to enhance transparency, accountability, and the incorporation of scientific expertise, the FDA should discuss vaccine candidates at the Vaccines and Related Biological Products Advisory Committee prior to issuing an EUA or granting a license. It should also consider livestreaming proceedings and incorporating other forms of public input.

Second, to help reduce concerns regarding safety and efficacy when COVID-19 vaccines come on the market, the FDA should engage in robust postmarketing surveillance, proactively establish adverse event reporting systems, and engage the successful National Vaccine Injury Compensation Program.

Third, the FDA and medical community should do a better job of informing the public of the meaning of and underlying evidence for its regulatory decisions. For example, informational tools like the "Drug Facts" labels that the FDA requires on over-the-counter medicines should be applied to EUAs.

Finally, the FDA should clarify evidentiary standards for EUAs and make them public to increase the consistency and soundness of EUA decisions and public confidence in them and decrease the risk of political intervention.

"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," said Nachlis. "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," he added.

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