Reagan-Udall Foundation 2026 Annual Public Meeting of the Board of Directors - 07/21/2026

Speech | Mixed

More Speeches by
FDA Officials

• Speeches by FDA Officials

Washington, D.C.

Remarks as prepared for delivery

• Thank you Susan [Winkler]. And good afternoon, everyone. It is my pleasure to join you for the annual public meeting of the Board of Directors of the Reagan-Udall Foundation
• I want to extend a special, personal thank you to the entire Foundation team for your incredible patience and flexibility. I know we had to reschedule this event a number of times, but it was deeply important to me to be here with you today. I am truly grateful that you worked so closely with us to find a mutually agreeable date and time so we could make this happen.
• I also want to recognize Susan Winkler's contributions. As a former FDA Chief of Staff, you understand as well as anyone the challenges we face on a daily basis. I appreciate your leadership and partnership in navigating the challenges we face and supporting us in our mission to protect and promote the health of the American public.
• Reagan-Udall has long played an essential and, I might add, often unsung role in the work we do. Like the FDA itself, the Foundation prioritizes the value of science and rigorous data to solve the challenges of public health. I think it's important to remember that the Foundation was actually created by Congress as an independent 501(c)(3) organization specifically "to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety."
• And, through our unique partnership, that's precisely what you've done, supporting our work to meet the continuing and often extraordinary challenges we face, both involving the remarkable advances in science we embrace, and the limits on our time and resources we manage.
• The Foundation helps fill gaps in our ability to meet the demands placed on us by building a community of stakeholders that leverages health data to inform regulatory decisions, advance medical innovation, and improve care for patients.
• Over the years, the Foundation has provided the Agency with crucial analysis and linkages across the health ecosystem on topics such as rare disease treatments, post-market research, tobacco, substance use, and food data.
• Your work allows us to use our resources more efficiently and effectively, to apply regulatory science in new and creative ways, and to better focus on what we should be doing -- data-driven decision-making. In short, our joint efforts help Americans build their trust in us.
• That's why I am so pleased that earlier this year we renewed our Cooperative Agreement with the Foundation, which will ensure that our Centers and offices can continue to work with the Foundation on important issues and activities.
• This is critical, because we have a lot on our plate and a lot we want to accomplish, and the Foundation will need to continue to play a key role in that work. If the coming year is anything like the extraordinarily productive one we just completed, then hold on tight.
• Allow me to give a very quick summary of just a few of the past year's highlights from across our vast array of responsibilities.
• In the food sector, we:
  • Approved several new natural food colors and continue to support companies in transitioning the nation's food supply from the use of artificial petroleum-based colors to alternatives derived from natural sources.
  • Renewed our focus on removing chemicals in the food supply, by standing up a office of post-market review.
  • Advanced efforts to on GRAS reform
  • Issued New Dietary Guidelines in coordination with HHS and USDA
  • Initiated the removal of outdated orange juice regulations that hurt U.S. growers, and
  • Commenced reviewing obsolete food identity standards that no longer benefited consumers.
• In the Medical Products space we:
  • Cut red tape to accelerate the production and approval of biosimilars
  • Took actions to modernize and eliminate unnecessary animal testing
  • Boosted domestic pharmaceutical manufacturing with the introduction of our precheck program
  • Removed restrictions on laboratory-developed tests
  • Expanded warnings about the use of ADHD treatments in young children
  • Began fixing opioid medication safety labeling
  • Launched a Framework for Accelerating Development of Individualized Therapies for Ultra-Rare Diseases, and
  • Took action (issuing warnings) against telehealth companies for illegal marketing of GLP-1s
• And, of course, we continue to review and approve a range of promising medical products. I'll just mention just a few here:
  • The first blood test diagnostic for Alzheimer's Disease
  • The first gene therapy for young children with sickle cell disease
  • The first treatment for patients with Cerebral Folate Transport Deficiency, and
  • A First-of-Its-Kind Device to Treat Pancreatic Cancer
• We also regularly respond to public health crises, most recent among them screwworm and Cyclospora.
• Again, this list just skims the surface. But it underscores two things: First, every day at the FDA is exciting, fulfilling, and incredibly beneficial for the American public. And second, we have an extraordinary staff that does extraordinary work each and every day.
• But we can expect the road ahead to be even busier. We are working toward building an FDA that is faster, more streamlined, and more nimble. We want to put in place regulatory flexibilities that will allow us to support the development and approval of more treatments, more quickly. But we want to do this without sacrificing safety or reliability, nor shortchanging our high standards of review. And we can and will do both.
• We are committed to ensuring that the FDA maintains its role as the global gold standard of scientific review. I want to underscore that the reason we have led the world is thanks to the expertise, judgment, and dedication of the FDA's workforce, who uphold the scientific integrity and public trust on which our agency's success depends.
• As the nation marks our nation's 250^th anniversary, the FDA is also celebrating an anniversary this year - its 120^th . I think this juxtaposition speaks volumes, because it makes clear that the American people, for nearly half of our country's existence, have relied on the FDA or its predecessor agencies to protect them from dangers to their health. That history is filled with stories of courage and creativity, and countless groundbreaking achievements where we have helped translate scientific discovery into real-world benefits for the American people.
• Over those 120 years we've seen enormous changes in science, technology, industry, and many other areas. In thinking about this history and looking forward, one thing is abundantly clear - the FDA's mission is more vital today than ever. We are part of an 'innovation renaissance, involving scientific and technological advances that will allow us to transform medicine, food, and public health in ways previously unimaginable, delivering profound benefits for patients and consumers.
• That's why we've developed an exciting new framework, the FDA's Public Health Pillars, to help guide us. We announced the pillars just last week, and they represent a strong new foundation for our Agency that reflects our commitment to modernization, scientific excellence, and a more proactive approach to protecting and promoting public health.
• The pillars are focused on broad concepts with specific action items: ensuring that we are the global leader in innovation and the best place in the world to innovate; strengthening America's health security; helping Americans gain faster access to safe, effective, and more affordable medical products; and continuing to promote wellness and build a healthier America.
• Together, these pillars offer a bold and comprehensive vision for the FDA's future - one that empowers informed decision-making, supports American innovation, and delivers better health outcomes for all Americans.
• Let me give you one example of how we're putting this into practice, relating to the first pillar: making America the leader in biomedical innovation. Some of you may already be familiar with Operation TrialBlazer, which is the FDA's roadmap to accelerate and modernize clinical research across the full continuum of drug development -from the Investigational New Drug (IND) phase to late-stage pivotal trials. It's designed to help maintain U.S. leadership in biomedical research and pharmaceutical innovation and reverse the unfortunate trend of clinical research moving overseas and combat the competitive pressure we face.
• We think this can make a real difference. But Operation TrialBlazer is just one piece of a broader, coordinated effort to advance our competitiveness and help ensure that Americans have reliable access to safe, quality medicines by strengthening domestic pharmaceutical manufacturing, and ensuring that regulatory frameworks keep pace with innovation.
• As you can tell, we've got a full plate before us. More than ever, the FDA is called upon to protect the health of the public and to empower consumers to make healthy choices they can have confidence in. We will continue to take our responsibilities to the American public very seriously, embracing our roll not only as a trusted regulator, but also as a great scientific institution that does not stop learning, improving, and earning the public's trust each and every day.
• The FDA will continue to lead the way, preserving a reliable and dependable regulatory model, letting the data drive our decisions, and maintaining our commitment to gold standard science.
• The Foundation's work and ability to adapt to a complex, rapidly changing health landscape bolsters our ability to accomplish this. And so, let me again extend my gratitude to the Reagan-Udall Foundation for everything they do as a partner to the FDA. You allow us to make a meaningful difference in the lives and health of Americans, every day, and to maintain our unwavering commitment to scientific integrity, regulatory standards, public health and patient safety.
• Thank you.

• Content current as of:

  07/21/2026