USA – FDA commits to data transparency in COVID EUAs

As the time draws near for the leaders in the global race for a vaccine against COVID-19 to submit emergency use authorization (EUA) authorizations to the US Food and Drug Administration (FDA), the agency has proclaimed a new commitment to transparency.

With a stated goal of disclosing information from COVID-19-related EUA review documents “as appropriate and consistent with our longstanding practice of posting scientific reviews after new drug and biological product approvals,” FDA also reserved to itself the ability to redact trade secrets or other information that would be exempt from disclosure under the Freedom of Information Act (FOIA) or protected from disclosure by other legislation.
In a 17 November statement announcing the agency’s ongoing commitment to transparency for COVID-19-related EUAs, FDA commissioner Stephen Hahn, MD, said, “I am announcing today that our drug and biological product centers intend, to the extent appropriate and permitted by law, to publicly post their reviews of the scientific data and information supporting the issuance, revision or revocation of EUAs for all drug and biological products, including vaccines, as part of our COVID-19 response…