April 2, 2021
The following quote is attributed to Acting FDA Commissioner Janet Woodcock, M.D.
“As we continue our COVID-19 response, it is critical that we learn from both our successes and the challenges we experienced, to best improve our operations.
"We have identified five key activities from the FDA COVID-19 Pandemic Recovery and Preparedness Plan Initiative for further development and implementation.
"We seek to improve our effectiveness, efficiency and transparency. This work will strengthen the agency’s public health infrastructure and build the resilience to respond in an emergency.”
- In January, the U.S. Food and Drug Administration published a summary report from an independent third-party review of the agency’s pandemic response as part of our COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) initiative.
- The report identified a number of options for strengthening our COVID-19 response while building resilience to respond to future emergencies.
- After an evaluation of the FDA’s priorities, workload and budget, measured against the demands posed by both the agency’s ongoing pandemic response and our traditional public health responsibilities, five areas have been identified for initial focus. The first area includes two PREPP recommendations folded into one. These include:
- Reviewing aspects of the EUA processes for medical products and identifying areas for potential improvement. The objective is to ensure transparency and facilitate appropriate integration of these products including diagnostics, therapeutics and vaccines into medical care.
- Reviewing science-based communications to ensure the agency continues to provide timely and accurate communications to the public.
- Evaluating inspectional approaches using next-generation assessment technologies, such as virtual and video-enabled platforms, to further our inspectional reach.
- Evaluating the current supply chain tracking, monitoring and assessment systems to identify gaps and challenges to help stakeholders improve supply chain resilience.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.