ORLANDO – Was December just a bit of holiday indulgence for the generic industry, or were the end-of-year submissions the beginning of a trend that could fuel friction between industry and FDA?

FDA's Office of Generic Drugs Director Kathleen Uhl didn't address the question at the Generic Pharmaceutical Association's annual meeting on Feb. 24, focusing instead on how the agency is meeting all its user fee obligations and starting to move applications through more quickly as deadlines shorten.

But for sponsors, some of the data Uhl presented could be cause for concern that the agency is getting a large number applications it feels are inadequate.

Things hand actually been looking up for agency and sponsors of late. After an Everest of 635 submissions in July 2014 (sponsor were aiming to beat a deadline for new stability requirements), the number of ANDAs that FDA received sank into the single digits per month, but has since recovered and settled between the high 20s and high 50s.

And as FDA worked through the bolus and overhauled its review mechanisms in general, more and more ANDAs started getting approved (see chart).

However, submissions jumped to 75 in September, and Uhl noted that in December, there were 180 ANDAs submitted, "which leads us back to the more traditional model where industry would send in a large number at the end of the calendar year."

But reestablishment of that pattern could also lead to the return of another more worrisome trend – low quality applications.

Most of the December cohort has been through filing review, Uhl noted. Unfortunately, "about a third of them will probably be RTRed, and what I have heard from my staff is that the main reason for RTR are insufficient stability and insufficient dissolution."

That one-third rate is a fair bit higher than the portion of applications that had been bounced during the first three years of GDUFA and the three years before that.

The refusal rate has been 18% in the GDUFA years and averaged 16% from FY 2010 to 2012 (see table). December's preliminary rate is even slightly higher than the refuse-to-file rate in the initial years of the new drug user fee program, which ranged from 10%-30%, Uhl said.

Whether the end-of-year performance was a blip or the beginning of a trend remains to be seen, but if there are many more months – or even just many more holiday months – that result in a large number of applications returned to sponsors un-reviewed, industry will likely remain pretty unsatisfied with the user fee program, regardless of how well FDA is hitting its metrics.

User Fees Haven't Had Much Impact On Refuse To Receive Actions – So Far
Fiscal Year	Number of RTRs	Percentage of Submissions	Average
2010	146	18%	16% over the three years leading up to user fees.
2011	142	16%
2012	156	14%
2013	193	19%	18% in the three full years since GDUFA implementation.
2014	191	13%
2015	124	23%
Source: FDA, based on cohort year of submission. Numbers reflect current data and will be further scrubbed for formal reporting purposes.

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