Posted 13 December 2017
By Zachary Brennan
The US Food and Drug Administration (FDA) last month began releasing new information a monthly basis related to generic drugs.
Whereas in previous years, the agency released monthly statistics on 12 different categories related to FDA’s review of abbreviated new drug applications (ANDAs), now the agency releases monthly data on 30 different categories.
The new categories will shine a light on metrics where the generics industry has struggled in recent years, like first-cycle approvals, and in other areas that are new to FDA, like major and minor amendments. For instance, in October 2017, the agency said that 26 of 87 ANDA approvals were first-cycle approvals. And of the 156 ANDA amendments submitted, 88 were minor while 60 were considered major – a difference that industry has already taken issue with.
In terms of which new metrics to keep an eye on, Robert Pollock, senior adviser at Lachman Consultant Services, told Focus that watching pre-submission facility correspondence and prior approval supplements (PAS) will be interesting. "The former because it will be indicative of the number of products for which expedited reviews will be requested and the later because now that there are no fees for PAS, [we can] see if firms are less likely to try to sneak a supplement by in a CBE-30 or if now they don't feel the need to try to take the risk."
FDA spokesman Jeremy Kahn also explained to Focus: "The Agency hopes that these metrics will serve to stimulate further submission of quality applications and showcase the modernized ANDA assessment process."
And even though there are more metrics, FDA says it’s still planning to release the monthly figures on the same regular basis.
"FDA strives to post the preliminary metrics for a given month (Approvals, Tentative Approvals, Complete Responses, and ANDA receipts) in the first week of the following month, with the rest of the metrics posted by the end of the following month," Kahn added. "These time frames can vary depending on holidays, application volume, and/or the time needed for data verification in a given month."
Article updated on 12/14/17 with quote from Robert Pollock.