The House Subcommittee on Health held a hearing on July 15 to discuss ways to maintain America’s leadership in biomedical innovation and examine the Food and Drug Administration’s (FDA) role in advancing U.S. drug development.
Chairman Morgan Griffith said, “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. 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.”
Congressman Buddy Carter discussed his experience as a pharmacist, saying, “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… We’re going to beat them [China] 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 raised concerns about administrative burdens associated with clinical trials data submission. Dr. Verst responded by highlighting digital technologies: “With regard to the use of real-world evidence, life science models, digital twins, novel trial designs… [these are] absolutely critical… 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 addressed challenges faced by rare disease companies due to inconsistency within FDA review divisions. Ms. Winckler said collaboration among FDA centers through initiatives like its Rare Disease Innovation Hub has helped address these issues: “There are further opportunities; it comes from greater collaboration and conversation with patient communities… but then also conversation among divisions at FDA and explanation where they may diverge.”
The House Energy and Commerce Committee oversees legislation concerning energy policy as well as health care matters such as pharmaceutical pricing; it traces its origins back more than two centuries when it was formed as part of Congress’s original standing committees, according to the official website.