The world in which FDA operates today is one of growing complexity, new challenges, and increased risks. And thanks to revolutionary advances in science, medicine, and technology, we have enormous opportunities that we can leverage in order to overcome many of these challenges for the benefit of public health.
As a regulatory agency that makes its decisions based on the best available science, while maintaining its far-reaching mission to protect and promote the public health, FDA is uniquely prepared and positioned to anticipate and successfully meet these challenges.
FDA’s responsibilities continue to escalate as we work to fulfill the mandates of groundbreaking legislation passed in recent years, including the Family Smoking Prevention and Tobacco Control Act of 2009, the Patient Protection and Affordable Care Act of 2010, the FDA Food Safety Modernization Act of 2011, the FDA Safety and Innovation Act of 2012, and the Drug Quality and Security Act of 2013. Further, with so many FDA-regulated products coming from overseas, FDA is keenly focused on the complexities of regulating in a global marketplace.
This Strategic Priorities document articulates the goals and priorities that guide our Agency. It creates a framework that will allow us to integrate and achieve our five strategic priorities – regulatory science, globalization, safety and quality, smart regulation, and stewardship.
While the priorities are individually important, they are also interconnected and cannot be addressed in isolation. Thus, for example, regulatory science is at the core of everything FDA does and therefore it influences and in turn is affected by any actions taken involving the other priorities. The cross-cutting nature of this plan will help FDA achieve the greatest benefits.
This document also sets forth FDA’s core mission goals and objectives, such as improving and safeguarding access to – and making better informed decisions about – the products FDA regulates. It describes in detail key strategies to help the Agency fulfill its public health mission.
The many new responsibilities Congress has given FDA serve as an important backdrop for this plan, which includes a focus on advancing ways the Agency can continue to efficiently manage and build upon these new authorities. This will allow us to maintain our responsive and responsible stewardship of the public health for the 21st century.
The Strategic Priorities document is the result of an extraordinary and talented team of dedicated public servants who contribute each day to our mission to protect the health and safety of the American public, and who strengthen FDA’s preeminent global reputation. These steadfast employees understand that the work we are engaged in and the challenges we face have extraordinary consequences for real people. It is through their commitment that we are able to meet this challenge and fulfill the potential and promise offered by science today.
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs