FDA Commits to More Transparency When Authorizing COVID-19 Medicines

FDA Commissioner Stephen Hahn pledged yesterday that the agency will publicly post detailed explanations of all Emergency Use Authorization (EUA) decisions, including all COVID-19 vaccine candidates now in the pipeline.

The pledge reaffirms the agency’s existing transparency policy as it routinely releases a detailed explanation in the case of product approvals. But it has not done that on EUAs in the past.

So far this year, the agency has posted details of one EUA revocation and one authorization but is now committing to doing that routinely. The information is presented in the form of a narrative that explains what led the agency to authorize or revoke the EUA application.

The move comes in response to calls from Congress and elsewhere for greater transparency in the agency’s approvals of COVID-19 vaccines and therapeutics, with Democrats accusing the Trump administration of applying pressure to cut corners in a rush to get a vaccine approved.

“We recognize that disclosing information from the scientific review documents supporting the issuance, revision or revocation of EUAs for drugs and biological products, including vaccines, will contribute to the public’s confidence in the agency’s rigorous review of scientific data and the appropriate use of authorized products,” Hahn said.

The Commissioner qualified the transparency pledge by saying that the agency will make the documents public “to the extent appropriate and permitted by law” and it may have to redact some information.

Hahn emphasized that the EUA approval process is insulated from politics. “For an EUA to be authorized, FDA’s career scientists conduct a rigorous evaluation of currently available scientific evidence about a medical product,” he said. — Martin Berman-Gorvine