Main Challenge for Generic Drugmakers? First Cycle Approvals, FDA Says

The biggest outstanding challenge for the generic drug industry moving into the second iteration of its user fee agreement is multiple cycle reviews before approval, Kathleen Uhl, director of the US Food and Drug Administration’s (FDA) Office of Generic Drugs told participants Tuesday at a generic drugs forum for small businesses.

According to FDA’s latest complete set of data, only 9% of abbreviated new drug applications (ANDAs) won approval in the first review cycle, which is significantly lower than the more than 90% of new drug applications that win approval in the first review cycle. But the 9% shows significant progress on the approximately 1% of ANDAs that won approval in the first review cycle before the first Generic Drug User Fee Amendments (GDUFA) of 2012 was initiated, Uhl said.  

Common deficiencies for the generic industry highlighted by Uhl include:

“If you do what we tell you to do, you should get an approval,” Uhl added.

Michael Kopcha, director of FDA’s Office of Pharmaceutical Quality (OPQ), also told participants that a lot of the quality issues FDA sees are related to the use of old manufacturing technologies. He noted that his office is trying to drive the use of more emergent technologies and that in 2016, OPQ “enabled the approval of the first switch from batch to continuous manufacturing.”

Uhl also noted that under the second iteration of GDUFA there is a “no application left behind” clause that will establish a goal date for every ANDA. She explained that the first couple of years of GDUFA were meant to build up the agency’s infrastructure to deal with the massive ANDA backlog, but for the last two years, FDA has seen record ANDA approvals.

Ted Sherwood, director of FDA’s Office of Regulatory Operations in OGD, also noted that there has been some confusion with regard to the ANDA backlog, with some saying that thousands of applications still have not been addressed by FDA.

FDA has met its agreed-to goal of reviewing 90% of the backlog within the first five years of GDUFA I, he noted, adding that there are only about 120 ANDAs that FDA has yet to address, and most of them are complex in nature. A few of those 120 are also still awaiting an industry response.