Washington, D.C. – Congressman Michael C. Burgess, M.D. (R-TX) and Congresswoman Angie Craig (D-MN) introduced the FDA Advancing Collection of Transformative Science or FACTS Act. The FACTS Act will provide clarity for the Food and Drug Administration (FDA), empowering the agency to consider Real World Evidence generated during an Emergency Use Authorization (EUA) for an application’s final approval.
“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,” said Congressman Burgess. “We all have been positively affected by the real-world success of those vaccines that are now seeking full FDA approval. Congress has already recognized the value of real-world evidence through the bipartisan passage of the 21st Century Cures Act. The FACTS Act will clarify that real-world evidence collected during an Emergency Use Authorization (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.”
“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 – real world evidence gathered during a public health emergency provides valuable insight into the safety and effectiveness of drugs, medical devices and other treatments,” said Congresswoman Craig. “Today, I am proud to join Rep. Burgess in introducing this commonsense legislation to ensure that real-world evidence can be considered by the FDA to streamline the development and production of lifesaving products.”
