Another Record Year for US Generic Drug Approvals in 2017

Regulatory News | 05 October 2017 | By Zachary Brennan

The US Food and Drug Administration (FDA) has approved more abbreviated new drug application (ANDA) in 2017 than any other year, according to the latest FY 2017 activities report.

The 763 approvals (or 927 approvals and tentative approvals) is 112 more generic approvals than last year, which set the previous record for the highest tally in a year, and 271 more than 2015 and 354 more than in 2014.

And unlike in 2016, when FDA issued a vastly higher number of complete responses than in the previous year, the number of complete responses decreased in 2017, from 1,725 in 2016 to 1,603 in 2017.

The total number of ANDAs received by FDA also significantly outpaced all prior years as 1,292 were received, which is 439 more than the 853 total ANDAs received by FDA in 2016. 

In terms of first generics (meaning the first competitors for their reference products), FDA has tallied a total of 54 approvals in 2017 (with three months to go), which compares with 73 total approvals in 2016 (FDA counts first generic approvals on the calendar year, not the fiscal year).

The uptick in ANDA approvals and decline in rejections for the latest fiscal year is thanks to almost 1,000 new employees that FDA was able to hire because of the first Generic Drug User Fee Amendments (GDUFA). The second iteration of GDUFA, which in August was renewed, took effect 1 October.

This reauthorization creates a new user fee structure, aims to help small businesses and speeds the review of generic drugs even further with 8-month priority reviews, in addition to increasing interactions between the agency and companies working on complex generics.

FDA Commissioner Scott Gottlieb, like his predecessor Rob Califf, has prioritized the approval of more generics to bring down the cost of pharmaceuticals. This trend of record-breaking years of approvals could continue into FY 2018, though the number of review cycles for generic drugs is still an area of concern for industry and FDA.

Activities Report of the Generic Drug Program (FY 2017)