FDA commissioner commits to COVID-19 EUA transparency

By The Science Advisory Board staff writers

November 17, 2020 -- The U.S. Food and Drug Administration (FDA) Commissioner Dr. Stephen Hahn reaffirmed the agency's commitment to transparency regarding the emergency use authorization (EUA) process, including decisions to issue, revise, or revoke them.

Earlier in the year, the FDA launched the COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) to help apply best practices and lessons learned from past emergencies. Hahn explained that part of this work focuses on increasing transparency, particularly in regard to disclosing information from scientific review documents supporting the issuance, revision, or revocations of EUAs for drugs and biological products, including vaccines. He said that this is an opportunity to build the public's confidence in the agency's review and the appropriate use of authorized products.

In a press release, Hahn announced that the drug and biological product centers of the FDA intend to publicly post their reviews of the scientific data and information supporting EUA decisions. They have already posted some scientific review documents, including the EUA revocation of hydroxychloroquine sulfate and the EUA authorization of COVID-19 convalescent plasma, and will continue to post documents going forward.

They will disclose information from the EUA review documents after the disclosure review and process is complete.

The commissioner explained that if the available scientific evidence changes or if new information becomes available during the EUA process, then the agency will pivot and potentially adapt a given EUA, including revising the authorized use or revoking the EUA -- both of which have been done during the COVID-19 pandemic.

As part of its commitment to transparency, the FDA convened a Vaccines and Related Biological Products Advisory Committee (VRBPAC) as an open committee meeting to discuss generally the development, licensure and authorization of COVID-19 vaccines. It is also creating resources to help the public understand the different regulatory and scientific steps around vaccine or drug development, including the investigational new drug process and data safety monitoring boards.

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