By Stephen M. Hahn, M.D., Commissioner of Food and Drugs and Anand Shah, M.D., Deputy Commissioner for Medical and Scientific Affairs
Over the past year, we’ve seen first-hand the devastation and turmoil wreaked by the COVID-19 pandemic; the unparalleled economic and personal tragedies inflicted on families and communities across the nation. We’ve also had the opportunity to be part of the extraordinary governmental response to this unparalleled public health emergency.
Working closely with other government agencies, industry, the health care community, researchers, and others, the US Food and Drug Administration has helped foster the knowledge and understanding of the SARS-CoV-2 virus necessary to bring it and the disease it causes under control.
We are extremely proud of the role the FDA has played on many different fronts in this effort. That work has included expediting access to COVID-19 medical countermeasures for the detection, protection against, and treatment of COVID-19, supporting the stability and quality of medical product and food supply chains, and ensuring that the agency’s decisions are guided firmly by science using an open and transparent process to ensure continued public confidence.
To build on these efforts, in April 2020, we began the FDA COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) initiative, with a formal launch in August 2020. The goal was to strengthen our on-going COVID-19 response and resiliency for future emergencies. To this end, we engaged an external third party for an independent and objective review of the agency’s response, to assess actions, and identify forward-looking opportunities for the agency’s consideration.
The external third party prepared an objective summary report of the PREPP initiative. In furtherance of our commitment to openness and transparency, we are pleased to make the report available here: FDA COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative: Summary report.
The report reflects highlights of the agency’s response, accomplishments and activities and describes a broad set of potential prospective actions that the agency could consider going forward. To be clear, the report’s recommendations are not a “to do” list for the FDA and are deliberative, not binding and not exhaustive. The agency will need to carefully consider the relevance and implementation feasibility associated with the ideas as it decides the appropriate courses of action in the continually evolving COVID-19 response and recovery.
Enhancing regulatory agility
From the beginning, we have worked to become more nimble in our regulatory response, streamlining processes to make it easier for developers and scientists to send inquiries and requests, and moving as quickly as possible to support medical developments while ensuring scientific rigor. At the same time, we’ve responded with appropriate flexibility when necessary and possible to adapt our processes and regulatory tools.
Since the start of the pandemic, we have published and revised more than 65 industry guidance documents related to COVID-19 to provide recommendations on matters ranging from clinical trial conduct to emergency use authorizations (EUA) for vaccines to prevent COVID-19. We’ve reviewed over 2,300 EUA requests and issued over 600 EUAs for medical countermeasures, including therapeutics, vaccines, tests, personal protective equipment, ventilators and other devices to address patients’ needs in preventing, diagnosing and treating COVID-19. We have reviewed and conducted inspectional activities in relation to nearly 400 COVID-19 therapeutic candidates and numerous COVID-19 vaccine Investigational New Drug applications.
Additionally, we’ve issued more than 150 warning letters to companies to enforce the safety and quality of COVID-19-related products and identified over 1,240 fraudulent and unproven medical products related to COVID-19.
Moreover, even as we have been focused on the demanding and life-saving response to COVID-19 and dealt with the enormous additional burdens in terms of work hours that this has meant for our staff, it’s important to remember that the FDA has continued to meet the agency’s vital non-COVID-related public health responsibilities.
Building on our strength to respond to public health emergencies
As an agency whose mission embraces using the most rigorous science and best available data to protect and promote the health and safety of the American public, the FDA’s role and responsibilities are only magnified during public health crises such as this one.
Our expertise, combined with the tools and resources we have at our disposal, make us uniquely equipped to respond to public health emergencies. At the FDA, we’ve used this experience to develop and hone a number of effective strategies in the course of our responses to previous public health crises, including the Ebola Virus, outbreaks from foodborne illnesses, and dangerously tainted medical products.
Today, we continue to develop and strengthen our ability to respond. One of the hallmarks of being prepared is the continuous evaluation and application of lessons learned from experience. Our response to the COVID-19 pandemic has been no different.
Promise and possibilities
It’s important to keep in mind that our response to COVID-19 is constantly evolving given the dynamics of the public health emergency. Our workforce remains deeply engaged in leading pandemic response actions, which continue to rapidly evolve. Consequently, the FDA is regularly reviewing its actions and developing and considering alternative approaches to achieve the best possible public health goals under our current authorities. In doing so, the agency will evaluate the ideas in the PREPP initiative report, along with other inputs and considerations, to continue to adapt its approach to the COVID-19 response and to build future resilience.
The FDA is at its core, a science-based, learning organization. What that means is that the agency makes decisions based on the application of rigorous science and that it continues to learn from those decisions and the actions it takes to implement them by regularly reevaluating, revising and strengthening what we do to help ensure the health and safety of American patients and consumers. We are confident that the FDA will continue along this path, continually growing and learning, on behalf of its mission to protect and promote the health and safety of the American public.