FDA Voices
An Enduring Mission in a New Era: The FDA Public Health Pillars
By: Kyle A. Diamantas, J.D., Acting Commissioner of Food and Drugs and the U.S. Food and Drug Administration Executive Team
This year marks the 250th anniversary of the United States—a fitting time to reaffirm the U.S. Food and Drug Administration’s enduring mission and our responsibility in shaping the future of public health.
Today, America stands on the precipice of an ‘innovation renaissance’ that will transform medicine, food, and public health in ways previously unimaginable. Life changing medical products, breakthrough diagnostics, safer food technology, and novel manufacturing platforms have the potential to deliver profound benefits for patients, consumers, and public health. Realizing these opportunities will require a regulatory environment that safely and effectively accelerates these innovations to the American people.
Back when Congress enacted the Food and Drugs Act in 1906, establishing the precursor to the modern FDA, antibiotics did not exist. Polio still terrified families. There were no organ transplants or CT scans. Cheap fillers were used to imitate pure foods. The life expectancy in the United States was barely 50 years of age. The FDA’s history is full of stories of how the agency helped translate scientific discovery into real world benefits for the American people. Few institutions have had to keep pace with scientific change and innovation on this scale.
Throughout every generation, FDA staff have faced challenges their predecessors could not have imagined. And while the agency has not always been perfect, we have long been the global benchmark because, as science advanced, industries transformed, and new threats emerged, we were resolute in rising to the opportunities. The pace of change hasn’t slowed, and Americans deserve that same commitment from the FDA today. They deserve an FDA that not only helps deliver the next generation of breakthroughs but also advances the health of the people and animals those breakthroughs are meant to serve. Meeting that responsibility requires staying true to the FDA's enduring mission while continuously adapting to a rapidly changing world.
For 120 years the FDA's public health priorities have remained rooted in the same enduring mission. Today we are articulating our priorities in a way that reflects the scientific, technological and geopolitical reality shaping this new era of innovation as well as the future of public health.
First, we are ensuring America stays the best place in the world to innovate.
Science is moving faster than ever, while countries around the world invest heavily to rival the United States in biotechnology and advanced manufacturing. America must be the first place in the world where scientists, entrepreneurs, and companies choose to develop tomorrow's cures, treatments, and diagnostics. In order for the next generation of breakthroughs to be discovered, developed, manufactured, and delivered here first, our regulatory system must keep pace by becoming smarter, faster, and more reliable.
The FDA’s role is to provide predictable regulation, rigorous science, timely reviews, and clear expectations. When this exists, innovators build laboratories and manufacturing facilities and conduct clinical trials here in America—not somewhere else. This type of innovation ecosystem within the United States creates a vital pathway to better care for American patients, delivering earlier access to lifesaving treatments and diagnostics. To succeed, the FDA is embracing artificial intelligence and digital tools to become more efficient, modernizing clinical development by making better use of real-world evidence, and expediting pathways for early-stage research so promising therapies reach patients sooner. We also understand that success requires the contributions of multiple stakeholders, and we are actively collaborating with other U.S. Department of Health and Human Service agencies, academic institutions, the investment community, small and large businesses, healthcare providers, and patients to ensure the United States remains the best place in the world for innovation and investment.
The wellness and security of the American people depend on the United States remaining the premier choice to develop the medicines and technologies that will define the future.
Second, we are strengthening America's health security.
The FDA’s budget is less than 1% of the Pentagon’s budget, but we have a critical role in defending America — whether from viral outbreaks, malicious biological threats, or supply chain disruptions.
The disruptions of recent years remind us that resilient supply chains, domestic manufacturing capacity, cybersecurity, and preparedness, are essential components of public health.
Americans shouldn't have to wonder whether essential medicines and devices will remain available during a crisis. Hospitals shouldn't worry about fragile supply chains halfway around the world. Public health depends on reliability and preparedness long before an emergency strikes.
The FDA has a unique responsibility to anticipate emerging risks, act early, and continuously modernize oversight – including inspections, data-driven risk targeting, and collaboration, internally and externally. Through partnership with other federal agencies to bolster data analytics, we can better identify vulnerabilities in the products and supply chains Americans rely on and reduce dependence on foreign sources for critical products. By strengthening domestic production, modernizing inspections, supporting countermeasures, and reinforcing product integrity, we can better protect our nation against future public health threats. Public health security is national security.
Third, we are helping Americans gain faster access to safe, effective, and more affordable medical products.
Patients, especially those with rare, untreatable, or fatal diseases, experience time with a heightened sense of urgency. Every moment matters as they await new treatment options.
And with nearly six out of every 10 U.S. adults reporting to have taken at least one prescription medication in the past year, medical products are also increasingly becoming a significant part of every family’s budget. Americans deserve access to safe and effective medical products without unnecessary delays or unnecessary costs.
This demands that we constantly ask whether we're using the best science available, whether we're making patient-centered decisions efficiently, and whether we're giving innovators a fair and predictable process.
Scientific rigor and regulatory efficiency do not have to be opposing values—they depend on one another. Modernizing regulatory pathways, embracing new technologies, strengthening patient-focused product development, and ensuring timely, science-based reviews all make it easier for safe and effective innovations to reach the people who need them most.
The same is true when it comes to affordability. While the FDA doesn't set the price of medicines, we can help foster conditions that encourage competition, speed the development of generics and biosimilars, expand the availability of over-the-counter drugs, and reduce unnecessary regulatory delays that ultimately add cost throughout the healthcare system. This competition serves patients by expanding access to lifesaving treatments.
The American patient must remain firmly at the center of each of our decisions.
Fourth, we continue to help build a healthier America.
The food Americans serve their families, the information on labels, and the products they use everyday shape health long before someone walks into a doctor's office. True public health goes beyond treating illness—it requires helping people stay healthy in the first place. The FDA absolutely has a role to play in helping Americans avoid the burdens of chronic disease and live longer, healthier lives.
Americans deserve confidence in the safety, quality, and transparency of these products. To deliver that, we are strengthening our food system and post-market oversight, modernizing nutrition policies, reducing harmful exposures, advancing sound tobacco regulation, supporting the safety and effectiveness of medical devices, ensuring the safety of cosmetics, and making science continue to guide every decision. The health of this nation is ultimately strengthened by creating the conditions that not only enable Americans to recover but allow them to thrive.
An FDA ready for the future.
The FDA has always been more than a regulator; it is one of America's great scientific institutions. Institutions that endure for 120 years do so because they never stop learning, improving, and earning the public's trust.
The FDA's first century helped make America the world's leader in biomedical innovation and public health. Though our mission remains unchanged, our responsibility now is to ensure the next century builds on that legacy—empowering our expert career workforce, accelerating scientific discovery, strengthening our nation's competitiveness, and delivering better health for every American.