GAO Critiques Transparency of FDA’s Emergency Use Authorizations

The FDA has not been fully transparent about its Emergency Use Authorizations (EUAs) for COVID-19 treatments as it “does not uniformly disclose” its scientific review of safety and effectiveness data for EUAs, as it does for approvals for new drugs and biologics,” the Government Accountability Office said in a new report to Congress.

In an announcement on Tuesday ahead of the report’s release, the FDA said it will in future publicly post its reviews of the scientific data for EUAs for all drugs and biologics, including vaccines, subject to certain redactions (DID, Nov. 18).

The GAO report said that for all four COVID-19 treatments the FDA has so far granted EUAs, it released fact sheets for healthcare providers, but they contained different levels of information. For example, the fact sheets for chloroquine and hydroxychloroquine and COVID-19 convalescent plasma were “silent on the evidence supporting the EUA,” but the fact sheets for remdesivir and bamlanivimab included clinical trial results and supporting data, the GAO said.

The agency did not release clinical decision memos for chloroquine, hydroxychloroquine, remdesivir and bamlanivimab, while it did release a memo along with its authorization letter for convalescent plasma that summarized the literature it had reviewed, the GAO noted.

On June 15, the agency revoked its EUA for hydroxychloroquine and chloroquine, and only then made public “further details on the evidence” for the March 28 authorization, in a memo attached to the revocation letter, the report said.

“Given the gravity of the pandemic, it is important that FDA identify ways to uniformly disclose this information to the public. By doing so, FDA could help improve the transparency of, and ensure public trust in, its EUA decisions,” the report said.

The GAO recommended that the FDA “identify ways to uniformly disclose to the public the information from FDA’s scientific review of safety and effectiveness data — similar to the public disclosure of the summary safety and effectiveness data supporting the approval of new drugs and biologics — when issuing EUAs for therapeutics and vaccines, and, if necessary, seek the authority to publicly disclose such information.”

Read the GAO’s full report here: www.fdanews.com/11-18-20-GAO.pdf. — Martin Berman-Gorvine