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Regulatory Focus™ > News Articles > 2020 > 10 > Top CDER officials discuss budget priorities, staffing and COVID

Top CDER officials discuss budget priorities, staffing and COVID

Posted 16 October 2020 | By Michael Mezher 

Top CDER officials discuss budget priorities, staffing and COVID

Patrizia Cavazzoni, MD

With negotiations underway for the next iterations of the US Food and Drug Administration’s (FDA) new and generic drug user fee programs, top officials from the Center for Drug Evaluation and Research (CDER) discussed budget and staffing priorities in a call with the Alliance for a Stronger FDA on Friday.
 
Budget priorities
 
“We have really made major strides thanks to Congress’ support in the appropriations that we received in 2019, in investing in modernizing the platforms that support the review of applications and the data analytics platforms that we intend to build and refine to allow us to communicate with the external world, including sponsors and researchers, using cloud-based technologies,” said CDER Acting Director Patrizia Cavazzoni.
 
Other priorities for the center, including supply chain surveillance and drug shortages, have been heightened by the pandemic, Cavazzoni said.
 
“During the pandemic we have expanded our activities when it comes to monitoring the supply chain for shortages, trying to find ways to intervene earlier when we see some shortages on the horizon. This is an area where we will require more investment going forward,” she said.
 
Cavazzoni also suggested that changes to how FDA’s Sentinel surveillance system is funded would bring more stability and predictability to the program. “We have to think about continuing to invest in postmarket safety. We have to think about the fact that Sentinel, which was mandated by Congress, is still largely supported by user fees … this is another area where we think there are some opportunities when it comes to budget priorities,” she said.
 
Staffing
 
For years, FDA’s ability to hire and retain talented staff has been a focus of both Congress and industry, with authorities and goals related to hiring and human resources being baked into both the 21st Century Cures Act and the current Prescription Drug User Fee Act (PDUFA VI) program.
 
“We need to have a well- and reliably-funded hiring capability at the agency level because we’re very dependent on that and that has not historically been the case,” Cavazzoni said. “In order for us to hire and retain reviewers we really need to have funding of the core capabilities that support hiring at the center and the agency level.”
 
“The 21st Century Cures authority is much more streamlined. It allows us to hire people faster and to also focus on the talent pool that we want to focus on.” Cavazzoni said. “We have really seen this year the results of this new hiring strategy.”
 
While Cavazzoni said she did not want to give specific numbers on CDER’s hiring, she said the Center has seen a net increase in staff of more than 100 employees year over year, which is three times the increase the center saw in 2019.
 
Speaking at the Reagan-Udall Foundation’s annual meeting this week, FDA Commissioner Stephen Hahn reported that the agency as a whole had hired 2,308 employees and lost 1,281 in FY2020, a net gain of 1,027, much higher than the agency’s net gain of 135 employees in FY2019.
 
With the new authorities implemented, Cavazzoni said that CDER has “turned the corner” on hiring and retention.
 
Going forward, Cavazzoni said she would like to bring on new staff to “develop some capabilities within CDER to really drive innovation and testing of innovative approaches to drug development.”
 
“The pandemic has really brought this gap to the forefront. Yes, we have sponsors who are really making valiant efforts to race to develop therapeutics and vaccines [and] the government is very involved in an unprecedented way,” she said.
 
But, she said, “There really isn’t a place where we can sort of systematically study and test new approaches to expedite drug development.”
 
Cavazzoni added that creating that capability is, “Extremely important because we need to really find a way to tie that investment to what our stakeholders really care about.”
 
Peter Stein, director of the Office of New Drugs within CDER, concurred. “Our ability to have the expertise, the experience and the right staff to manage those changes and support them — and even to lead them — is critical to the success of what we do,” he said.
 
COVID-19
 
Both Cavazzoni and Stein brought up some of the challenges CDER and OND staff are facing due to the COVID-19 pandemic, including increased workload and longer hours.
 
“We’re very conscious of the fact that we need to make sure that our staff don’t burn out, because this is a marathon, not a sprint,” Cavazzoni said.
 
Stein noted that there has been “a tremendous increase in the number of [investigational new drug applications] INDs and pre-INDs and reviews of protocols,” during the pandemic, which his office has tried to address by shifting staff to more heavily impacted divisions.
 
“One of the strategies we’ve taken is to try to move resources to support them, that’s not something that we’ve traditionally done before in OND. Even though those divisions that are most affected have been working incredibly hard and long hours, we’ve had a lot of help from other divisions,” Stein said.
 
Cavazzoni added that, “The non-COVID work is still there and we have been advancing that work in parallel” with the center’s COVID-19 response. “Our view is that the pandemic response is not a reason to not meet our other commitments," she said.
 
While stressing that the CDER has been able to meet most of its user fee goals during the pandemic, aided in part by alternative approaches to pre-approval inspections, Cavazzoni said that in some cases CDER has missed goal dates for new and generic drugs, “Due to the inability to do on-site inspections.”

Tags: CDER, coronavirus, FDA, US

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