CDER chief calls for additional budget funds as staff departures spiked last summer – Endpoints News


When Patrizia Cavazzoni officially took the helm of the FDA’s Center for Drug Evaluation and Research last April, much of the attention on her rise to the top focused on her relative lack of experience, having joined the agency in 2018.

But as Cavazzoni called for closing the gaps in CDER’s long-term budget priorities at an Alliance for a Stronger FDA event on Monday, his comfort in his relatively new and increasingly difficult position was clear.

“You have to recognize that this is not a routine year,” she said, pointing not only to the pandemic, the reauthorization of user-fee programs (due before the end of September), which represent the core of CDER funding, but the spike in CDER staff departures last summer, shifting the center from a net positive gain for new staff in 2021 to a net negative.

“Attrition really dropped in the first year of the pandemic, 2020, and since then it’s been on the rise,” she said, noting “a bit of a spike last summer, not unexpectedly , after months of lockdown, and quite a lot of retirements too , as many employees postponed their retirement to fight the pandemic, and after a year or a year and a half, they continued with their retirement plans deferred retirement.

Since then, the attrition rate has hovered around its pre-pandemic level, she said, noting that about 5,300 people work at CDER (as of the end of February).

While acknowledging that the job market is currently tough and there is a lot of competition for CDER staff, Cavazzoni noted that the agency is now allowing medical examiners to work entirely remotely. And she specifically calls for more funding from Congress, echoing a plan to give the FDA a 34% budget increase in 2023, unveiled by the Biden administration last week.

“As far as user fees go, we are well funded. We are grateful for one-time supplements, but the amount of resources CDER needs to move forward, as with opioids, also requires core funding through budget appropriations. As we enter 2022 and 2023, we have continued demands in addition to doubling down on pandemic-related work, which by no means has stopped,” Cavazzoni said.

On the data and analytics side, she said CDER is building a central data and analytics environment, called “CDER 1,” which will support the deployment of new technologies, like AI, to tap into the agency’s vast wealth of data.

“There’s so much knowledge in the FDA that it’s hard to put it all together because it’s hard to find,” she said, noting that CDER often hears industry talking about inconsistent decision-making. during the year. And “that’s where knowledge management comes in…and having the tools to achieve a greater degree of consistency,” she said.

On the security side, CDER is working on two new surveillance projects, including one called “FAERS 2,” which is tied to the agency’s adverse event system but rooted in new technologies, including a cloud-based environment for exchanging data, and new tools for scientists to dissect adverse event data and quality.

But she said CDER needs people to fill those drug safety teams, assembled by the FDA’s Office of Surveillance and Epidemiology, which hasn’t had medical or safety reviewers in the past. .

She also said the OSE could also benefit from a policy team, as there has been a lot of work around the international harmonization of safety standards.

“Lastly and most importantly, Sentinel [the FDA’s safe­ty sur­veil­lance sys­tem] could greatly benefit from more funds from the budgetary authority for day-to-day activities. Sentinel is largely an unfunded mandate, and user fees have helped, but you’d think a national platform like this would have stronger funds for its day-to-day core business,” she said. declared.


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