CDER Priorities: During the Pandemic and for 2021

CDER Deputy Center Director for Operations Dr. Patrizia Cavazzoni met with the Alliance (by conference call) on August 4. She began the meeting by thanking the Alliance for their work and mentioned the Alliance’s 2018 meeting with CDER Director Woodcock, which she attended. Dr. Peter Stein, Director of the Office of New Drugs also participated in the call.Budget, Funding, and Priorities. With regard to CDER resources and priorities, Dr. Cavazzoni pointed to modernizing technology platforms that can support application reviews and other activities. She also pointed to CDER’s drug compounding activities, which were previously unfunded.Increased FDA appropriations have also supported CDER’s advanced manufacturing activities, which have the effect of promoting domestic manufacturing. Among other things, CDER has approved six continuous manufacturing applications. CDER has also initiated a pilot program since much of this field needs to be demonstrated, rather than taken from an existing “how to” plan.She continued: in the FY 21 budget, CDER requested additional funding for drug science activities to determine how to adopt new drug development techniques including enhanced biomarkers and novel clinical trial designs. If funded, CDER would work with third parties, academic institutions, and scientists to study and advance new drug development approaches. This is both a short- and long-term priority of CDER.Recruitment, Hiring and Retention. Dr. Cavazzoni described the increasingly important role of the recruitment tools contained in the 21st Century Cures Act. This has allowed CDER to recruit a substantial number of new staff and given the agency needed flexibility. However, there are multiple recruitment and pay scales that often slow down the agency’s efforts. She expressed interest in moving toward a single direct hiring authority that would apply to all recruitment and employees.COVID-19. Not surprisingly, CDER has had to divert staff to COVID-19 activities. Within CDER that has primarily been to cover three functions: (1) therapeutics (particularly in the Office of New Drugs and Office of Generic Drugs), (2) supply chain surveillance and mitigation of drug shortages, and (3) regulatory enforcement.In addition, CDER has tried to work closely with sponsors of non-COVID-19 clinical trials who faced operational issues in conducting their trials. As these submissions come in, CDER anticipates increased focus on resolving analytic issues created by necessary deviations from original protocols.At the start of the COVID-19 pandemic, CDER created a triage team to facilitate drug reviews and assure maximum productivity. As a result, COVID-19 work is being completed, while CDER remains on track to meet its user fee requirements. Conducting on-site inspections has continued to be difficult.The accomplishments this year -- under very stressful conditions -- have only been possible because of the tremendous dedication of staff and their willingness to work long hours.Future Impacts from the COVID-19 Experience. CDER is looking at the COVID-19 experience to see if there are ways to improve the review process in the future. Among the items that Dr. Cavazzoni pointed to were: learning how to increase surge capacity; tightening the monitoring of and response to supply chain disruptions; and harnessing technologies such as remote monitoring to continue trials during COVID-19. CDER may consider creating a hub within the center to deal with emerging technologies.Evolution of Clinical Trials. CDER has a working group to evaluate decentralized trials and consider virtual medicine and telehealth technologies. Looking forward, Dr. Stein sees digital health technologies being used to monitor patients, ensure the safety of clinical trial participants, and inform endpoints. As the clinical trial landscape changes over the next 5-10 years, FDA is likely to need additional resources for data analysis and analytical tools.Editorial Note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.