Inspections down in 2020, but CDER hit most goal dates
Regulatory News | 26 January 2021 |
During the pandemic, the US Food and Drug Administration (FDA) continued to attempt to meet goals mandated by its various user fee programs – and, generally, the agency succeeded, though a steep drop in inspections hampered some efforts.
The details of how well FDA’s Center for Drug Evaluation and Research (CDER) met its user fee commitments were laid out in a 26 January report covering the third and fourth quarters of federal fiscal year 2020 (FY20), which ended 30 September 2020.
Addressing how the public health emergency of the pandemic would shape CDER’s approach to inspections required balancing the need to continue “mission-critical and prioritized inspections” with consideration of alternative approaches, noted FDA in its report of goal date data.
“While continuing to conduct mission-critical and prioritized inspections, due to practical constraints, such as travel limitations, quarantine and social distancing requirements or lockdowns, we have been increasingly relying on inspection alternatives,” wrote FDA. These include reviewing historical compliance data for the facility in question, relying on information from “trusted foreign regulatory partners” once appropriate confidentiality agreements are in place, requesting facility records, and conducting drug sampling at the US border.
Across all approval types, the number of cases where pre-approval inspections were skipped in favor of alternative approaches rose from 48% in the third quarter to 60% by the fourth quarter of FY20.
During the third quarter of FY20, CDER acted on almost all its obligations under the Prescription Drug User Fee Act (PDUFA) on or before the assigned user fee goal date. The agency met goals for 98% of original applications, 100% of efficacy supplements and 99% of manufacturing supplements. For the fourth quarter of the fiscal year those figures fell slightly, to 94% each for original applications and efficacy supplements, and to 97% for manufacturing supplements.
For obligations under the Generic Drug User Fee Amendments (GDUFA), CDER met goal dates during the third quarter of FY20 for 94% of original applications, 98% of original applications with imminent approval, and for 99% of both prior approval supplements (PAS) and PAS with imminent approval. In the fourth quarter, those figures also dropped slightly across the board, to 93% for original applications, 96% for both original applications with imminent approval and PAS, and 97% for PAS with imminent approval.
CDER hit target date goals during the third quarter of FY20 for 100% of biosimilar user fee act (BsUFA) original applications, supplements with clinical data, and manufacturing supplements. The office held onto a perfect score for supplements with clinical data but fell to meeting goal dates for 95% of manufacturing supplements and 75% of original product applications.
In all, CDER approved a total of 31 original abbreviated new drug applications (ANDAs) for drugs or biologics used to treat patients with COVID-19, 17 in the third and 14 in the fourth quarter of FY20. Manufacturing supplement approvals for COVID- 19 therapeutics regulated by CDER totaled 591, with 314 coming in the third quarter of the fiscal year and the remaining 277 approvals occurring in the last quarter of FY20.
In the report, CDER noted that the data include only CDER-specific actions and thus will differ from those reported to Congress in annual agency-wide performance reports, which are based on the fiscal year of receipt and also contain figures from FDA’s Center for Biologics Evaluation and Research (CBER).
FDA
The details of how well FDA’s Center for Drug Evaluation and Research (CDER) met its user fee commitments were laid out in a 26 January report covering the third and fourth quarters of federal fiscal year 2020 (FY20), which ended 30 September 2020.
Addressing how the public health emergency of the pandemic would shape CDER’s approach to inspections required balancing the need to continue “mission-critical and prioritized inspections” with consideration of alternative approaches, noted FDA in its report of goal date data.
“While continuing to conduct mission-critical and prioritized inspections, due to practical constraints, such as travel limitations, quarantine and social distancing requirements or lockdowns, we have been increasingly relying on inspection alternatives,” wrote FDA. These include reviewing historical compliance data for the facility in question, relying on information from “trusted foreign regulatory partners” once appropriate confidentiality agreements are in place, requesting facility records, and conducting drug sampling at the US border.
Across all approval types, the number of cases where pre-approval inspections were skipped in favor of alternative approaches rose from 48% in the third quarter to 60% by the fourth quarter of FY20.
During the third quarter of FY20, CDER acted on almost all its obligations under the Prescription Drug User Fee Act (PDUFA) on or before the assigned user fee goal date. The agency met goals for 98% of original applications, 100% of efficacy supplements and 99% of manufacturing supplements. For the fourth quarter of the fiscal year those figures fell slightly, to 94% each for original applications and efficacy supplements, and to 97% for manufacturing supplements.
For obligations under the Generic Drug User Fee Amendments (GDUFA), CDER met goal dates during the third quarter of FY20 for 94% of original applications, 98% of original applications with imminent approval, and for 99% of both prior approval supplements (PAS) and PAS with imminent approval. In the fourth quarter, those figures also dropped slightly across the board, to 93% for original applications, 96% for both original applications with imminent approval and PAS, and 97% for PAS with imminent approval.
CDER hit target date goals during the third quarter of FY20 for 100% of biosimilar user fee act (BsUFA) original applications, supplements with clinical data, and manufacturing supplements. The office held onto a perfect score for supplements with clinical data but fell to meeting goal dates for 95% of manufacturing supplements and 75% of original product applications.
In all, CDER approved a total of 31 original abbreviated new drug applications (ANDAs) for drugs or biologics used to treat patients with COVID-19, 17 in the third and 14 in the fourth quarter of FY20. Manufacturing supplement approvals for COVID- 19 therapeutics regulated by CDER totaled 591, with 314 coming in the third quarter of the fiscal year and the remaining 277 approvals occurring in the last quarter of FY20.
In the report, CDER noted that the data include only CDER-specific actions and thus will differ from those reported to Congress in annual agency-wide performance reports, which are based on the fiscal year of receipt and also contain figures from FDA’s Center for Biologics Evaluation and Research (CBER).
FDA
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