WASHINGTON—House Committee on Oversight and Reform Ranking Member James Comer (R-Ky.) and Oversight Republican lawmakers pressed U.S. Food and Drug Administration (FDA) Acting Commissioner Janet Woodcock on the agency’s failure to process numerous pending Emergency Use Authorization (EUA) applications for lifesaving COVID-19 therapeutics and treatments. In the letter to the Acting Commissioner, the Republican lawmakers call for information on the EUA applications for therapeutics and treatments received, rejected, and pending, as well as the anticipated approval date for the next therapeutic or treatment.
“We write to inquire about the numerous stalled Emergency Use Authorization applications for lifesaving COVID-19 therapeutics and treatments at the U.S. Food and Drug Administration. Operation Warp Speed enabled the FDA to grant EUA for three COVID-19 vaccines in record time. Unfortunately, since those vaccines were approved, the Biden Administration has not encouraged or focused on quickly developing and distributing COVID-19 therapeutics. As health officials have confirmed the vaccine does not protect against infection from Omicron, it is critically important we develop viable therapies and treatments,” wrote the Republican lawmakers.
On March 31, 2020, the FDA created the Coronavirus Treatment Acceleration Program to use every tool at the agency’s disposal to determine which therapeutics are safe and effective for use against COVID-19. However, the Democrats’ American Rescue Plan Act, which was signed into law in March 2021, allocated less than 1 percent of the $1.9 trillion to developing therapies. As of January 19, 2022 the FDA has reviewed over 470 trials of potential COVID-19 therapeutics. But to date, the FDA has approved just seven COVID-specific therapeutics for emergency use and fully approved one treatment.
“It appears the Biden Administration is consistently behind the curve every step of the way on responding to COVID-19—including purchasing those few treatments that have been approved,” continued the Republican lawmakers. “The Trump Administration’s Operation Warp Speed accelerated vaccine development and production by placing advance orders so a supply would be available as soon as the FDA approved a vaccine. President Biden has failed to do the same for treatments leaving Americans with a very minimal supply of effective treatments at a time when we need them most. For instance, the orders placed by the Biden Administration for monoclonal antibodies and antivirals in the last two weeks will likely not be delivered until after the Omicron peak. That is unacceptable.”
The letter to FDA Acting Commissioner Woodcock can be found here.