As we all know, the pandemic has wreaked havoc with inspections of drug manufacturers, API manufacturers, and laboratory facilities, as well as inspection of clinical study sites.  Remote working, meeting problems, and just general pandemic fatigue has hindered some of the FDA’s work.  However, the statistics are not as bad as one might think, all things considered (unless you are one of the firms that can’t get your product approved pending a reinspection of your site).

Remember, the FDA’s user-fee commitments typically require review of 90% of applications, supplements, etc. within the specified user-fee goal dates established by each program (Prescriptions Drug User Fee Program (PDUFA), Generic Drug User Fee Program (GDUFA), and Biosimilars User Fee Program (BsUFA)).  As we page through the FDA’s recently posted update (here), you can see from the data extracted and provided below that the only metric that failed to meet the user-fee goal was for originals biosimilar applications in Q4 2020 and Q1 2021.  While other metrics did slip somewhat, the degree of slippage is less than expected, given the circumstances.  Please see the link above for other valuable information contained in this update.

  FY 2020 Q3 FY 2020 Q4 FY 2021 Q1
Original Applications 98% 94% 93%
Efficacy Supplements 100% 94% 95%
Manufacturing Supplements 99% 97% 98%
Original Applications 94% 93% 91%
Original Applications
with Imminent Approval
98% 96% NA Yet
Prior Approval Supplements 99% 96% 99%
Prior Approval Supplements
with Imminent Approval
99% 97% NA Yet
Original Biosimilar Applications 100% 75% 67%
Supplements with Clinical Data 100% 100% 100%
Manufacturing Supplements 100% 95% 94%