Summary of the Alliance webinar with CDER Director Dr. Patrizia Cavazzoni

The Alliance hosted its first budget overview webinar with CDER’s Director Dr. Patrizia Cavazzoni. During this well-attended event Dr. Cavazzoni highlighted several of CDER’s budget priorities included in the President’s budget request and reviewed some of the impressive accomplishments over the past year, including the importance and dedication of CDER’s staff. She started by noting that this is not a routine year given that the reauthorization of user fees, which provides more than half of CDER’s funding, is also underway.

Dr. Cavazzoni noted that some areas have been underfunded in the past. The FY 22 appropriation recently signed into law provides small increases for battling opioid issues and for the development of therapies for rare diseases. The FY 23 budget request repeats some of the requests FDA made for FY 22, including opioids. FDA also requests funds to bolster post-market surveillance. FDA would like to modernize the process for safety surveillance, developing teams and improving technology to keep up with industry.

Advancing therapies for underserved populations, including rare diseases, is a priority for CDER. The modernization of data analytics and technology platforms has become a priority. Alternative methods of inspection were started out of necessity and is an area for modernization. Work on strengthening the drug supply chain was begun with supplemental funding and resources provided by the American Rescue Plan. The initial focus is on essential medicine.

With respect to CDER’s budget keeping up with the demands it faces, Dr. Cavazzoni said user fees have been robust, as have been one-time supplemental funds. But core responsibilities require base budget authority (BA) funding to keep up with CDER’s priorities and the work they are doing.

Going forward CDER will be analyzing the comments it received regarding guidance for real-world evidence. The biosimilar regulatory research program will be started with the next user fee cycle. The pregnancy safety workgroup, a sustainable framework for emergency preparedness and pandemic response, and accelerating cures for rare diseases are all focus activities.

With respect to CDER staffing, CDER has a structured hiring plan in place that anticipates attrition. Every hire is a priority. Drug reviews, pharmacy compounding, PDUFA planning capacity, and rare disease scientific disciplines are all areas of need. There were 5,300 people in CDER as of the end of February, with a historically low rate of attrition in 2020. But attrition is increasing, with a spike last summer. Some employees had deferred retirements due to work surrounding the pandemic. Others are now looking at alternative opportunities. Competition for FDA staff comes from the private sector and other agencies. One positive area is the Office of New Drugs, with the medical reviewer discipline in particular. In turn, that has been made possible by greater leeway to hire skilled individuals who want to work remotely.

With respect to non-COVID-19 responsibilities, Dr. Cavazzoni said they have been able to meet review goals across programs despite the tremendous increase in workload. While supplemental funding has been good, it is not the kind that leads to the long-term hiring of staff. She identified compounding with education outreach to outsourcing facilities, the implementation of the Drug Supply Chain Security Act, and advanced manufacturing as important areas. Technology is now becoming a core activity.

In concluding the webinar, Dr. Cavazzoni said she is excited by so much work going on, especially the work on innovation. She wants to keep the staff engaged, particularly with its high workload compared to historic volumes.

Here is a summary of answers to some questions that were asked during the webinar.

Editorial Note: The week’s Analysis and Commentary section was written by the Alliance’s Executive Director, Steven Grossman.