FDA's Public Health Pillars
Protecting and Promoting the Health of All Americans
FDA’s Public Health Pillars are the foundation upon which FDA's mission, priorities, and operations will stand for the foreseeable future - anchoring everything FDA does to protect and promote public health.
Innovation and Global Leadership
FDA is committed to fostering an environment where American innovation in medicine, food, and technology can thrive, and where the U.S. regulatory framework positions American industry to lead globally.
FDA will modernize regulatory frameworks and pathways to keep pace with emerging technologies, strengthen the use of innovative scientific tools and data sources in regulatory decision-making, and reinforce its position as the global gold standard for regulatory science, consistent with its public health mission.
These efforts will promote more efficient, evidence-based oversight while supporting innovation across regulated industries, advance innovative, safe and effective medical products, and accelerate modernization and digitization of FDA’s internal systems, tools, and infrastructure to improve how the agency operates and serves the American people.
Key priorities include advancing regulatory frameworks for artificial intelligence, digital health technologies, and advanced manufacturing; expanding the use of real-world data and real-world evidence; centralizing and optimizing agency-wide systems and digital infrastructure to align tools with mission needs, improve oversight, and drive operational efficiencies; promoting international regulatory harmonization and collaboration through mutual agreements and standards alignment; advancing alternative testing methods that reduce reliance on traditional animal studies while maintaining scientific rigor; reinvigorating early-stage research and streamlining the IND process; and investing in regulatory science to ensure that FDA’s policies and decisions remain grounded in the latest scientific and technological advances.
Advancing National Health Security
FDA is committed to ensuring that the United States is prepared to respond rapidly and effectively to public health emergencies, biological and cybersecurity threats, as well as supply chain vulnerabilities that affect the availability of critical medical and food products.
FDA will strengthen the resilience, security, and preparedness of the nation’s public health infrastructure by expanding domestic manufacturing capacity for critical medical products while reducing dependence on foreign pharmaceutical supply chains, advancing the development and availability of medical countermeasures, and enhancing the agency’s ability to respond rapidly and effectively to emerging public health threats.
These efforts will help ensure a stable supply of essential products, protect the public from unsafe products, improve readiness for health emergencies, and support timely access to safe and effective interventions when they are needed most.
Key priorities include accelerating the development, evaluation, and availability of medical countermeasures; strengthening supply chain resilience and domestic manufacturing capabilities; modernizing emergency use authorization policies and processes for faster issuance and stronger evidentiary standards; enhancing pandemic preparedness and response capabilities; strengthening the cybersecurity of medical devices and drug manufacturing systems to protect the nation’s public health infrastructure from emerging digital threats; modernizing inspection, compliance, and enforcement activities, foreign and domestic, across all FDA-regulated products to ensure consistent oversight and deter misbranded, adulterated, and unsafe products; and preventing and mitigating shortages of critical drugs, critical foods, and other essential medical products.
Increasing Access to Affordable Medicines & Medical Products
FDA is committed to removing barriers that delay or limit Americans' access to safe, effective, and affordable medical products, including prescription drugs, biologics, medical devices, and animal products.
FDA will advance initiatives that strengthen the efficiency, predictability, and competitiveness of the medical product marketplace by accelerating drug approvals, expanding generic and biosimilar competition, reducing unnecessary regulatory burden where appropriate while maintaining strong safety and efficacy standards, and supporting innovation broadly.
These efforts will prioritize transparency throughout the review and approval process while supporting regulatory modernization to shorten time-to-market for safe and effective therapies.
Key priorities include accelerating generic drug approvals, advancing biosimilar development and uptake through guidance and education, modernizing regulatory frameworks, expanding access to medical devices and diagnostics, advancing the availability of safe and effective animal drugs and other veterinary products, effective use of Advisory Committees in supporting access, advancing reauthorization of the Agency’s user fee programs, including America First incentives that reward domestic development, and promoting patient-focused development.
Preventing Chronic Disease and Promoting Wellness in America
FDA is focused on addressing the root causes of chronic disease and poor health outcomes in America, with particular attention to the safety and quality of the food supply, tobacco and nicotine products, cosmetics, environmental exposures, and the integrity of the products Americans consume or use every day.
FDA will advance initiatives that enhance the safety, nutritional quality, and transparency of the nation’s food supply; reduce tobacco-related disease and preventable mortality through evidence-based product standards and oversight; strengthen oversight of cosmetics to protect consumers from unsafe ingredients and harmful exposures; and strengthen the scientific foundation for regulatory decisions that protect and promote public health.
These efforts will support rigorous review of food ingredients and additives, modernize oversight frameworks, and improve consumer access to clear, evidence-based information about the products they consume. Our vision is to ensure that food is a source of wellness for all U.S. consumers.
Key priorities include evaluating food and dietary supplement ingredients, including petroleum-based dyes, and modernization of the Generally Recognized as Safe (GRAS) framework; advancing nutrition policy and food labeling modernization; reducing dietary exposure to environmental contaminants such as heavy metals; supporting maternal and child health programs such as Operation Stork Speed; regulating tobacco and nicotine products to reduce initiation, promote cessation, and prevent tobacco-related disease and death; addressing overprescribing and supporting addiction prevention through labeling requirements, guidance, and public-facing health information; and advancing science-based cosmetics safety standards and improving transparency to protect consumers from unsafe ingredients and harmful exposures.
Taken together, these efforts will empower informed decision-making that leads to better health outcomes.
