Woodcock: FDA at Inflection Point in Pandemic
As the U.S. continues to recover from the Covid-19 health emergency, FDA acting commissioner Janet Woodcock says the agency is at a critical inflection point and will begin to “more closely examine our response to this crisis, gauge what does work and formulate and implement plans to effectively transition to what comes next.” Delivering the keynote address at the virtual Food and Drug Law Institute annual conference 5/18, Woodcock discussed how FDA will use its Covid experience to “build for the future.”
For example, Woodcock discussed how FDA’s One Health initiative was brought to the forefront due to the pandemic. The initiative is intended to recognize the interconnectedness of the health of people, animals, and the environment, and it advocates for a comprehensive approach to health and environmental problems versus a piecemeal approach. “By building bridges between physicians, veterinarians, environmental scientists, and public health professionals, the initiative aims to “promote, improve, and defend the health and well-being of all species,” the agency said earlier this year when describing the initiative.
FDA’s Office of Chief Scientist and CVM have been leading efforts in this area, which includes a focus on the possible animal origins of the pandemic, and the potential for future pandemics to arise from zoonotic disease. One Health also overlaps with work FDA is doing to counter antimicrobial resistance. “We're collaborating with stakeholders and other partners in our continuing efforts to support responsible stewardship of antimicrobials in both human and veterinary settings to preserve these critical tools,” Woodcock told the conference.
The pandemic has also given FDA enhanced awareness to having access to the best available science and the most rigorous data. “Good science and data really are the DNA of the FDA,” Woodcock said. “We need to expand our scientific and data capabilities. We need systems that do a better job talking to one another, and enterprise platforms that we can use across the agency for multiple purposes. Many new platforms we use today, which were groundbreaking when they're put in place are sorely in need of updating... To achieve this, we've launched the technology modernization action plan and the data modernization action plan. But technology of course is only half of the puzzle, as it has become more sophisticated and our world more connected, we need more and better data from new sources, and we have been working on this.”
Woodcock also said that during the pandemic the agency built on efforts to optimize design and conduct of clinical trials to diversify who’s included, and to add new data sources such as digital health data. Last year, FDA’s Oncology Center of Excellence began Project Equity and Project Silver, “which focus on increasing minority and geriatric patient enrollment and clinical trials in cancer, and bringing the voice of underrepresented populations to the world of drug development,” she said. “And our Office of Minority Health and Health Equity in the Office of Women's Health continue to raise awareness and advance efforts to increase the participation of minorities and women in clinical trials. We also continue to expand our use of real world evidence and real world data in our regulatory decision making, which can help strengthen clinical trials and transform the efficiency of product reviews, and also a post-market surveillance.”
Additionally, Woodcock addressed engagement with drug makers during the pandemic to better understand supply chain problems, discover early warning signs of potential manufacturing discontinuations or interruptions and help develop ways to mitigate risks of product shortages. She said that another area that gained attention during the pandemic was modernizing production systems using advanced manufacturing. “We recently established several research and regulatory programs for advanced manufacturing building on existing work,” she said. The goal is to help lower production costs, increase access to critical medical products and decrease the risk of supply disruptions, and the main aim here would be to improve the robustness of supply chain by redundancy of manufacturing, rather than having manufacturing concentrated in one large plant, “which is an vulnerable to a wide variety of different kinds of disruptions,” she said.