Health Subcommittee Holds Hearing to Examine Ways to Drive Efficiencies Across Early-Stage Clinical Development
WASHINGTON, D.C. - Today, Congressman Morgan Griffith (VA-09), Chairman of the Subcommittee on Health, led a hearing titled Maintaining America's Leadership in Biomedical Innovation: FDA's Role in Advancing U.S. Drug Development.
"The United States has always been the global leader in biopharmaceutical research and development, and it is important that we remain leaders in this space," said Chairman Griffith. "Maintaining America's position as the global leader in biomedical innovation requires a regulatory system that is both thorough and efficient. I am eager to find ways we can help ensure FDA can review drugs in a timely and predictable manner-not only to expand patient access to innovative treatments, but to also encourage companies to invest, develop, and manufacture domestically."
Watch the full hearing here.
Below are key excerpts from today's hearing:
Congressman Buddy Carter (GA-01): "I practiced pharmacy for over 40 years, and I saw nothing short of miracles as a result of research and development. And we want to continue with that. We want to make sure that we're letting the markets work and that we're letting capital flow to risk and that we're letting science lead. That is extremely important. I do understand and appreciate the point that has been made here about China and about them taking the lead. But we can't beat China by copying China, because China does not operate under the same rules and regulations that we do. We all understand that. We're going to beat them the same way that we beat Europe, and that is by doubling down on what actually made America the leader in the first place: entrepreneurial spirit, access to capital, free markets, and the best science in the world-and I still say we have the best scientists in the world, right here in the United States of America."
Congressman Troy Balderson (OH-12): "Clinical trials produce plenty of data but sponsors frequently report that the process of gathering and submitting this information is still unnecessarily complicated. Where are there opportunities for FDA to leverage digital technologies to reduce administrative burden, improve trial efficiencies, and allow researchers to spend more time developing therapies and less time navigating paperwork?" Dr. Verst: "With regard to the use of real-world evidence, life science models, digital twins, novel trial designs... [these are] absolutely critical. In addition, wearables, the use of patient-reported outcomes, digital connected devices, and reducing the burden on the investigators and patients is just incredibly important. The good news is that those digital data sets actually reduce time, burden, and cost in cleaning data. In fact, that data can be surfaced for early signal detection, thus accelerating development."
Congressman Tom Kean (NJ-07): "My district is home to numerous small, rare disease companies. These constituents and other companies have frequently raised concerns about inconsistency, and even within FDA review divisions. This is a significant source of uncertainty that translates to an unpredictable regulatory environment and disincentivizes investment in areas of unique need. What additional steps can the FDA take to improve consistency among FDA reviews of rare disease products, while also preserving an adaptive framework that acknowledges the unique challenges of rare disease drug development?" Ms. Winckler: "Thank you, and there are a couple of ways-one, I'll say, that the FDA's Rare Disease Innovation Hub has actually been quite helpful in bringing together not only the different product centers at FDA-Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, and Center for Devices and Radiological Health-and stimulating the conversation so that they can have a better understanding of what endpoint might be relevant in a rare disease and how to use that endpoint. There are further opportunities; it comes from greater collaboration and conversation with the patient communities to make sure that the end points that are being pursued are patient-relevant, but then also conversation among the divisions at FDA and explanation where they may diverge."
