FDA Continues Steady Reduction of Generic Drug Application Backlog

Regulatory NewsRegulatory News | 25 July 2016 |  By 

As the debate around high-priced pharmaceuticals and new ways to lower those costs continues, the US Food and Drug Administration (FDA) is speeding the approval of new generic drugs, according to the latest update to the agency’s in-depth look at the backlog of abbreviated new drug applications (ANDAs).

The new data (up to 1 July 2016) reveals that FDA has reduced its ANDA workload by about 500 applications in the first six months of 2016 (the ANDA dashboard recapping 2015 can be found here). The agency has also approved 315 more ANDAs over that same time period and sent 66 more complete responses (or rejections) for industry action.


And similarly to past dashboards (like the one from May), FDA continues to seek more information or require companies to correct what’s known as an “easily correctible deficiency” for the vast majority of ANDAs. And in case the ANDA approval process seems to be a formality, the latest statistics show that FDA continues to reject far more ANDAs than it’s approving. In fact, for all of 2016, except for January, FDA rejected more than twice as many ANDAs as it approved.


The release of the latest dashboard comes as Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at FDA, reported on 11 July via email that as of 1 July 2016, CDER has acted on more than 90 percent of the Generic Drug User Fee Amendments (GDUFA) backlog, thereby accomplishing the agency’s backlog commitment more than one year ahead of schedule. 

The confirmation of GDUFA’s success ahead of its deadline followed Woodcock’s prediction that the agency would accomplish the feat ahead of the next reauthorization of GDUFA, which is already underway.

Despite the success, a research letter recently published in JAMA found that of a sampling of 417 novel therapeutics, 210 were eligible for generic competition, though 36 (17%) had no generic drugs approved, 174 (83%) had one or more generic and 133 (63%) had four or more. Neurological drugs had the highest rate of having a generic equivalent, while oncology drugs had the lowest, according to the letter.

In addition, orphan-designated drugs “were significantly less likely to have at least 1, as well as 4 or more, generic approvals (55% and 27% respectively) than nonorphan-designated drugs (88% and 70%, respectively; P values < .001),” Ravi Gupta, Aaron Kesselheim, Nicholas Downing, Jeremy Greene and Joseph Ross, wrote.

The Generic Drug Review Dashboard as of 1 July 2016


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