The Food and Drug Administration (FDA) would be authorized to consider real-world evidence generated during an Emergency Use Authorization (EUA) for an application’s final approval under bipartisan legislation introduced by U.S. Rep. Michael Burgess (R-TX).
“Thanks to Operation Warp Speed, we all witnessed how the cutting of red tape led to three safe and effective vaccines, countless therapeutics, and life saving devices to combat this coronavirus,” Rep. Burgess said. “We all have been positively affected by the real-world success of those vaccines that are now seeking full FDA approval.”
The FDA Advancing Collection of Transformative Science (FACTS) Act, H.R. 4511, which Rep. Burgess sponsored on July 19 with original cosponsor U.S. Rep. Angie Craig (D-MN), would amend the Federal Food, Drug, and Cosmetic Act to authorize the use of EUA data and real-world evidence gathered during an emergency to support premarket applications for drugs, biological products and devices, according to the congressional record bill summary.
“Congress has already recognized the value of real-world evidence through the bipartisan passage of the 21st Century Cures Act,” said Rep. Burgess. “The FACTS Act will clarify that real-world evidence collected during an EUA can be used for the final review process for drugs, biologics and medical devices. This will help create efficiencies and will streamline the transition between an EUA, premarket submission and permanent marketing authorization.”
Rep. Craig added that while nothing can replace clinical research and long-term studies, “medical experts and scientists responsible for developing lifesaving drugs will be the first to tell you [that] real-world evidence gathered during a public health emergency provides valuable insight into the safety and effectiveness of drugs, medical devices and other treatments.”
H.R. 4511 has been referred for consideration to the U.S. House Energy and Commerce Committee.