U.S. Senator Mike Enzi, R-Wyo., is asking the Food and Drug Administration (FDA) how it plans to implement the Emergency Use Authorization (EUA) program for unapproved drugs, which Enzi said may play a crucial role in helping Americans return to some semblance of normal life during the COVID-19 pandemic.
The EUA program could help make potential COVID-19 therapies available to patients immediately while a possible vaccine moves through the full approval process.
“FDA’s role as the gatekeeper to the United States’ prescription drug marketplace is rarely so visible as it is now,” Enzi wrote. “As such, it is imperative that the public have a clear understanding of how FDA will implement its congressionally-delegated responsibilities and steer qualified therapies through regulatory hurdles on the basis of strong scientific evidence.”
On May 1, FDA issued an EUA for remdesivir – an antiviral medicine used to treat certain people in the hospital with COVID-19. There are more than 70 other clinical trials of potential COVID-19 therapies reportedly in progress. Enzi said FDA can consider these for more EUAs, which would allow health providers to immediately administer the products while drug sponsors continue to pursue full FDA approval, which can take more than a decade.
To read the full letter, click here.