FY 21, FY 22 Appropriations and CDER Priorities

Q: What can we expect in a post-election session of Congress with regard to appropriations bills?A: For FY 21 (current fiscal year), FDA and other agencies are being funded under a Continuing Resolution that extends until December 11. The CR limits spending to the FY 20 levels and restricts new program initiatives. While the House will be in session the week of November 16, it is expected that major consideration of funding issues might not begin until after Thanksgiving. This will, of course, depend on winners and losers from the election and the possibility that annual funding might be wrapped in a COVID-19 relief bill that is on a fast track.Conventional wisdom is that elections that result in a change of power will result in a CR that extends into February or March of next year. Then, funding issues are decided when the winners will have control. Conversely, the losers want to cut post-election deals while they still have some degree of control. It could happen that way, but the dynamic is not necessarily “winners and losers.” For example, the winners could decide that it makes sense to cut a deal — on terms more favorable to themselves — for FY 21 funding and then concentrate next year on getting their policy priorities into FY 22 funding. And, of course, winners and losers will have a different (and unknown) set of dynamics if we continue to have divided government.Q: What were some of the highlights of the Alliance’s October 16 webinar with Dr. Patrizia Cavazzoni, Acting Director of the Center for Drug Evaluation and Research (CDER) and Dr. Peter Stein, Director of CDER’s Office of New Drugs?A: In addition to some highlights provided here, there was an excellent write-up of the meeting in RAPS Focus (here).Funding Priorities. One important use of new monies for CDER would be to better support drug science activities, including the adoption of enhanced biomarkers and novel clinical trial designs. CDER would also like additional appropriated monies in order to work with academic institutions and scientists to study new drug development approaches.Hiring and Recruitment. CDER has been making progress, although challenges remain. The 21st Century Cures Act has been instrumental in allowing CDER to hire more staff than last year, despite the COVID-19 public health emergency.COVID and Non-COVID Workstreams. CDER has diverted staff to work on COVID-19-related activities including therapeutics review, supply chain surveillance, mitigation of drug shortages, and enforcement activities. One long-term benefit: CDER is learning how to better work across FDA to increase surge capacity. Despite the necessary urgency of COVID-19 work, CDER is currently on track to meet its user fee goals. To improve both workstreams, CDER officials are considering the potential to create a hub within the center to address emerging technologies.Evolving Nature of Clinical Trials. CDER has a working group that is evaluating ways to improve decentralized trials and address the use of telemedicine technologies. Digital health technologies may be used to monitor patients, ensure the safety of clinical trial participants, and inform clinical endpoints. CDER may need additional funds for data analysis and analytical tools.Status of Program Initiatives. BA appropriations have supported CDER’s work in regulating advanced/continuous manufacturing, which may be used to safely and efficiently produce large numbers of drugs. Additionally, advanced manufacturing may promote domestic drug development. CDER is also implementing cloud-based platforms to share information across multiple information technology systems.Collaboration Within and Across Centers. CDER and CBER work together to discuss analytical tools, clinical trial designs, and other drug review processes.Editorial Note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.