GAO Recommends That FDA Disclose Safety and Efficacy Data for Therapeutics, Vaccines When Issuing EUAs

November 20, 2020

FDA should identify ways to uniformly disclose to the public the information from its scientific review of safety and effectiveness data when issuing EUAs for therapeutics and vaccines, according to a new report released by the Government Accountability Office (GAO) this week. 

The report noted that FDA does not uniformly disclose its scientific review of safety and effectiveness data for EUAs, as it does for approvals for new drugs and biologics. However, the report states that FDA could help improve the transparency of and ensure public trust in its EUA decisions by doing so. Officials at the Department of Health and Human Services (HHS) neither agreed nor disagreed with the recommendation, but said they shared GAO's goal of transparency and would explore approaches to achieve this goal.

The CARES Act includes a provision for GAO to report on its ongoing monitoring and oversight efforts related to the COVID-19 pandemic. GAO examined the efforts of Operation Warp Speed to accelerate COVID-19 vaccine and therapeutic development, as well as FDA's use of EUAs for COVID-19 therapeutics and vaccines.

On Wednesday, FDA Commissioner Stephen M. Hahn, MD, issued a statement reaffirming FDA’s commitment to transparency around the EUA process and sharing the agency’s plan to provide more information about its decisions to issue, revise or revoke EUAs for drugs and biological products, including vaccines.