FDA Ahead of Schedule in Reducing Generic Drug Application Backlog

October 22, 2015

The FDA is well ahead of schedule in reducing the backlog of generic drug applications, officials said last week.

Overall, the agency has 5,707 applications that were received prior to Oct. 1, 2014, 3810 of which are currently undergoing some form of review. Of the remainder, 1,293 were approved, 206 were deemed “refuse to receive” and 398 were withdrawn. Less than 10 percent of the total has seen no filing review or communication.

Included in the 5,707 are 2,866 ANDAs that were pending as of Oct. 1, 2012, when GDUFA took effect. The FDA has acted on 80 percent of those and must review and act on 90 percent of that number by Sept. 30, 2017, according to GDUFA requirements.

The agency has different goal dates to address applications that were submitted after the second year of the GDUFA program, which ended on Sept. 30, 2014. For example, this year, the agency must review and act on 75 percent of ANDAs within 15 months.

An application submitted today, if done right, is going to have a faster approval time than one submitted prior to or in the first two years of GDUFA, said Ted Sherwood, acting director of the Office of Regulatory Operations.

During an FDA public meeting in June, GPhA and other industry groups called for major changes when the program is reauthorized in fiscal 2018, saying median review times for ANDAs are running about 48 months — up from 42 months in fiscal 2014 and 36 months in 2013, the first full year after GDUFA took effect. — Jonathon Shacat