Washington, D.C. – Congressman Michael C. Burgess, M.D. (R-TX) released the following statement after the House passed H.R. 7667, the Food and Drug Amendments Act of 2022, including two pieces of legislation authored by Burgess, the FACTS Act and the PATCH Act.
“Every five years, Congress evaluates the reauthorization of the user fees that support the Food and Drug Administration’s (FDA) review of new medical treatments,” Burgess said. “I am grateful that during this process, Congress worked to put forward a reauthorization that facilitates increasing transparency, urgency, and trust within FDA. It is important that two of my bills are included in this legislative package – the FACTS Act and the PATCH Act.”
“Operation Warp Speed cut the bureaucratic red tape and streamlined the process to discover and develop vaccines and treatments to fight against this Coronavirus. This not only saved us from the pandemic, but also served as an eye opener. It highlighted that with enough talent, resources, and people willing to find a cure, we can cut through excess time and barriers to achieve miracles in medicine and technology. If a new treatment is approved provisionally in response to a health emergency, FDA should be able to look at all of the real world data from that emergency response to decide if the treatment is safe and effective for the long term. The FACTS Act will cut bureaucratic red tape to make that happen. The PATCH Act will implement the necessary cybersecurity protocols and procedures for manufacturers applying for premarket approval through FDA to ensure that users are properly equipped to deal with foreign or domestic ransomware attacks.
“Benjamin Franklin once said, ‘a penny saved is a penny got.’ With America moving beyond this pandemic, it is important that we enact policies to ensure a more effective response from the FDA to any future pandemic or public health crisis.”