CDER missing more BsUFA target dates amid pandemic

Regulatory NewsRegulatory News | 17 March 2021 |  By 

The US Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER) faced a mountain of work and logistic challenges during the COVID-19 pandemic. While the agency met most of its user fee goals, its performance in moving original biosimilar applications along fell short of the pace it kept in other areas.
A new report from CDER tracks how well the agency fared in acting on applications by type and by quarter, looking at the last two quarters of fiscal year 2020 (FY20) and the first quarter of FY21, which ended 31 January 2021.
For obligations under The Generic Drug User Fee Amendments (GDUFA) and the Prescription Drug User Fee Act (PDUFA), CDER met its target dates more than 90% of the time for all application types, during all reported quarters. However, FDA did not yet have data for the first quarter of FY21 for original generic applications with imminent approval, or for prior approval supplements (PAS) with imminent approval.
By reaching the 90% mark for most of its target dates, FDA has met the goal it customarily sets in meeting user fee program commitments.
All types of Biosimilar User Fee Act (BsUFA) applications were handled on time 100% of the time in the third quarter of FY20. For supplements with clinical data, the perfect score was maintained through the reporting period. However, manufacturing supplements fell to 95% and 94% on-time handling in the last two quarters of reporting.
Original biosimilar product applications were acted on by BsUFA target date 75% of the time in the last quarter of FY20; in the first quarter of FY21, CDER hit its target date for just 67% of these applications.
In the third quarter of FY20, CDER approved 17 abbreviated new drug applications (ANDAs) and 314 manufacturing supplements. The number of ANDAs held stead with 18 approved in the first quarter of FY21, while supplement approvals fell to 149 for that reporting period.
FDA is continuing its risk-based approach to identify the subset of applications that require pre-approval inspections (PAIs), according to the report. About one in five applications will usually trigger a PAI.
While mission-critical domestic and foreign inspections continue, the Bioresearch Monitoring program’s  pre-approval and for-cause inspections are considered on a case-by-case basis when they are considered mission-critical during the pandemic.
“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 alternative approaches,” in conducting pandemic-era inspections, wrote CDER officials.
Alternative approaches may include using an inspection by a trusted international partner; using information that foreign regulatory partners share; and using facility records reviews to replace an on-site inspection.
By using this variety of alternate approaches, CDER reduced the need for PAIs by 48%, 60% and 52% in quarters 3 and 4 of FY20 and the first quarter of FY21, respectively. (RELATED: FDA looks to resume domestic inspections this monthRegulatory Focus 10 July 2020)
However, a recent Government Accountability Office report and testimony before a House subcommittee revealed that a longstanding and mounting backlog of mandatory inspections “could both extend the maximum interval between inspections beyond FDA’s five-year policy and reduce the resources available in fiscal year 2022 for inspecting the other highest priority establishments identified by its model.” (RELATED: FDA’s inspection backlog: GAO raises concerns as delays mount, Regulatory Focus 09 March 2021)
That report and testimony revealed details of FDA’s inspection program during the pandemic, including the fact that FDA completed just two routine surveillance inspections in India and none in China from the end of October 2020 through the first part of 2021.
CDER report


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Tags: biosimilars, CDER, FDA, US

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