By: Janet Woodcock, M.D., Acting Commissioner of Food and Drugs
The U.S. Food and Drug Administration’s response to the COVID-19 pandemic has brought the FDA’s critical public health role into sharper focus. The FDA’s public health mission, although most apparent during emergencies, is actually in operation every day of every year, protecting the American public from many threats.
In the coming weeks we will release a report highlighting some of the agency’s key accomplishments over the past year and illustrating the FDA’s profound impact in protecting Americans’ health and safety. As we close out 2021, however, I want to offer some insight into the themes that will continue to guide our public health agenda as we move into 2022.
Public Health and Consumer Protection
First and foremost, public health and consumer protection activities will continue to be the primary focus of FDA regulatory and compliance actions. We’ve made great strides in this area, as demonstrated, for instance, by our recent guidance to begin lowering the sodium content of foods, or the actions we’ve taken to reduce exposure to toxic elements in foods commonly eaten by babies and young children to the lowest possible levels, and by limiting fruit and other flavored vaping products that can be so attractive to young people. Through our initiative, “The New Era of Smarter Food Safety,” we are bringing new tools to bear on the longstanding problem of foodborne illness.
Equally important, though perhaps less well known or appreciated, are the activities of our shortage prevention programs and our generic drug review process, which support public health by working to ensure that essential medical products are available and accessible to people who need them. The pandemic resulted in severe shortages of many critical drugs, devices and biologics. In 2022 we will continue the work on making these products’ supply chains robust, reliable and redundant.
And of course, we continue at all times to support the safety and availability of the blood supply, to ensure the safety, effectiveness and availability of vaccines, to monitor the safety of human and animal food, to oversee the quality and safety of medical products on the market, and to protect the public from medical product fraud.
Modernizing the Agency to Keep Pace with Science and Technology
Second, the FDA will continue the important steps we are taking to modernize our processes and digital systems and keep pace with evolving science and technology. If science is the brain of the agency, data is its circulatory system. To do its job effectively, the FDA relies on the rapid consumption, processing, and dissemination of information. Data and data science are cross-cutting issues that require competency and forward thinking.
We already have made enormous progress in our digital modernization efforts, thanks to our newly established Office of Digital Transformation’s plan to streamline and enhance the FDA’s information technology, data, and cybersecurity abilities. We expect to make significant additional progress in 2022.
Our work on guiding the development and assessing the performance of innovative products intended to improve human and animal health is proceeding at a rapid pace. Scientific advances are leading to creation of new products and technologies in both the medical and veterinary fields, and in foods. We need to make sure that our reviewers have the scientific and technological capacity necessary to oversee the safe development of these products and also assess whether their demonstrated benefits outweigh potential harms. Hiring and retention of expert staff will be an area of focus in 2022.
We will also continue to promote the development of new and innovative products—drugs, biologics, medical devices, and medical foods—that demonstrate great promise for the prevention, diagnosis, and treatment of rare diseases or conditions. Rare diseases are both more difficult to study and offer fewer economic incentives for product development. The FDA has special programs intended to help advance treatments for these conditions.
Emergency Preparedness and Response
Third, the COVID-19 pandemic demonstrated the agency’s unique ability to adapt quickly and identify solutions in real-time to support FDA regulated industries, healthcare professionals, and the public. The pandemic also underscores the challenges we face as an increasingly global society. Going forward, we will continue to build, strengthen, and implement strategies that help ensure we are prepared for, stay ahead of, and respond to, any type of future emergency.
This includes emergency responses to many different types of challenges within the broad spectrum of FDA-regulated products, including foodborne illnesses, product tampering issues, man-made and natural disasters, and emergencies affecting FDA staff, systems, and facilities. Building on what we have learned, we will continue to enhance our agency’s preparedness and response capabilities through intra- and inter-agency exercises, plan development and execution, strengthened standard operating procedures, and enhanced incident management systems that will improve the overall operation and effectiveness of the FDA's emergency response.
Reflecting on 2021 as We Move Forward in 2022
As we move into the new year, we will build on our successes, learn from the challenges we have faced, and continue to embrace the same high standard which is informed by the best available science and most rigorous data.
We take our public health mandate seriously, and our focus is—and will always be—on the well-being of patients and consumers.