CDER Hit Most Review Targets in 2020 Despite Pandemic Obstacles

Despite the COVID-19 pandemic making manufacturing site inspections difficult in 2020, the FDA’s Center for Drug Evaluation and Research (CDER) met most of its drug and biologic review goals last year, but — as it warned it would — the agency struggled to meet its inspection goals.

In the third quarter, the agency did not conduct 48 percent of its pre-approval inspections, adopting “other tools and approaches” instead of an onsite inspection. And that figure increased to 60 percent in the final quarter.

The FDA has been using several strategies in lieu of inspections, including compliance history reviews of facilities, the use of information shared by regulatory partners through mutual recognition and confidentiality agreements, record requests for facilities and sampling drugs at the border.

According to data spanning the third and fourth quarters of fiscal 2020, the agency reviewed all original biosimilar product applications, supplements with clinical data and manufacturing supplements on time in the third quarter.

While reviews of supplements with clinical data saw a perfect performance again in the fourth quarter and manufacturing supplements dropped only slightly to 95 percent, the agency was only able to review 75 percent of original biosimilar product applications by their target date.

CDER hit 98 percent of its review targets for original prescription drug applications and 99 percent of its targets for manufacturing supplements in the third quarter, while reviewing all efficacy supplements on time. This dropped slightly in the fourth quarter, where it reviewed 94 percent of original applications and efficacy supplements and 97 percent of manufacturing supplements by their target dates.

Reviews of generic drug-related applications also remained strong despite the pandemic, with 94 percent of original generic drug applications and 98 percent of generic applications with imminent approval reviewed on time in the third quarter, dropping slightly to 93 and 96 percent, respectively in the fourth quarter.

The agency hit its target dates for 99 percent of prior approval supplements (PAS) and PAS with imminent approval in the third quarter, though these numbers dropped to 96 and 97 percent, respectively, in the next quarter.

Read the CDER report here: www.fdanews.com/01-27-21-UserFee.pdf. — James Miessler