EUAs are evolving for the better, expert writes

Regulatory NewsRegulatory News | 02 November 2020 |  By 

Lessons learned from early COVID-19 emergency use authorizations (EUAs) granted by the US Food and Drug Administration (FDA) could go far to improve public trust in a future EUA or approval of a vaccine – and in the regulatory process itself, Herschel Nachlis writes in the Health Affairs Blog.

While FDA has suffered some potential missteps – such as the now-revoked hydroxychloroquine EUA – and problematic political pressure on its process, the agency has improved its efforts to bring emergency therapeutics to patients, according to Nachlis, who researches pharmaceutical regulatory policy at Dartmouth College in Hanover, NH.

For its convalescent plasma EUA “the agency both relied on a greater evidentiary basis and was more transparent about its decision-making process” than it was for the hydroxychloroquine EUA, Nachlis writes. The decision on convalescent plasma was made in part on the considerable data generated by the Mayo Clinic Expanded Access program, an observational study with more than 35,000 patients enrolled (RELATED: Lawmakers, experts raise questions after convalescent plasma EUA, Regulatory Focus 25 August 2020). Conversely, the hydroxychloroquine EUA was based on a non-randomized, open-label trial of just 36 patients.
Further, the agency posted its clinical memorandum summarizing the data on which the decision was based as well as the authorized indications, dosages and use.

“Such transparency is particularly important when the agency is granting market access for a product based on data that is less rigorous than what would be required for a standard approval,” Nachlis writes, adding that FDA should follow the precedent it set in issuing the convalescent plasma EUA for all future EUAs. “Such improvements would serve to clarify the context in which an authorization is made, provide a transparent and comprehensive accounting of the decision making process, and enable the public and health care practitioners to access more information as they make decisions about medical treatments.”

FDA guidance on a potential EUA for a COVID-19 vaccine also may bolster public confidence in the agency’s actions (RELATED: FDA issues COVID-19 vaccine EUA guidance after clash with White House, Regulatory Focus 06 October 2020). The guidance, which has been termed “EUA-plus” by some, goes far to provide specific requirements for a COVID-19 vaccine – more specific than has been seen in previous EUAs. And while issuance of the guidance was delayed and allegedly opposed by the White House, FDA efforts “yielded new regulatory standards that were robustly and privately communicated to the firms working on COVID-19 vaccines, even before the FDA was eventually able to publicly release the guidance,” according to Nachlis.

Health Affairs Blog


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Tags: coronavirus, FDA

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