Cavazzoni discusses CDER staffing, FY2023 budget priorities

Regulatory NewsRegulatory News | 05 April 2022 |  By 

Dr. Patrizia Cavazzoni

The US Food and Drug Administration’s (FDA) budget request for FY2023 reflects a focus on combatting the nation’s opioid epidemic and improving postmarket surveillance, said Patrizia Cavazzoni, director of FDA’s Center for Drugs Evaluation and Research (CDER). Also, after a low attrition rate during the pandemic, vacancies are now trending upward as CDER staff is departing for new opportunities, she said on call with the Alliance for a Stronger FDA on Monday.
The FDA has requested $8.4 billion in President Biden’s FY2023 budget, a $2.1 billion (34%) increase over the previous year. (RELATED: FDA seeks $8.4B in FY 2023 to modernize regulatory infrastructure, prep for future pandemics, Regulatory Focus 28 March 2022)
The budget reflects increases in areas that have been “underfunded” in past budget requests, such as battling the opioid crisis and bolstering postmarket surveillance of medical products.
Cavazzoni said, “When it comes to opioids CDER has relatively small authority devoted to opioid work, and over the past few months we have really redoubled our efforts in this space by looking at all the relevant areas and asking ourselves what we can do more or differently when it comes to our efforts in battling the opioid crisis.”
FDA requested $38 million to help combat the opioid crisis by decreasing exposure and preventing new addiction; supporting the treatment of those with opioid use disorder; fostering the development of novel pain treatment therapies; and improving enforcement.
The budget also reflects efforts to enhance postmarket safety surveillance. FDA requested $5.6 million in FY2023 in this area.
“We need to modernize our approach to safety surveillance from the operational aspects, as well as the expertise that we bring to safety surveillance technology,” she said.
This funding is needed to “keep up with the technological advances that we see in industry and the complexity of postmarket surveillance and the ever-increasing number and sources of data,” she said.
Historically low attrition
Cavazzoni said that CDER experienced “historically low attrition in 2020,” which has since trended upwards. She attributed the low attrition rate to a substantial number of employees who decided to postpone retirement as part of their “commitment and dedication to fighting the pandemic.”
Yet attrition is now on the rise as staff who previously delayed their retirement are now beginning to do, and other employees have decided to pursue other opportunities.
The attrition rate is now 8%, a level that is comparable to the pre-pandemic level. “We had a bit of a spike last summer … not unexpectedly because after months of lockdown everybody started looking at potentially what is out there and looking at other opportunities.”
“When it comes to hiring, not surprising this year, we are in a slight net loss, and this is really reflected in what is going on around us in the broader ecosystem. Also, there is a lot of competition for our staff,” Cavazzoni said.
To recruit new talent, the agency is allowing newly hired reviewers to work remotely. “When it comes to new hires, we have been hiring scientists remotely with the understanding that it would stay remote. That has been a great bonus for us because it has expanded our reach,” Cavazzoni said.


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