November 2014 Generic Approvals at Lowest Point since GDUFA Implementation

After checking the generic drug approvals on FDA’s website today, I was disappointed to see that OGD only approved 11 ANDAs in the month of November.  Prior to this, the lowest month was July 2014 when OGD approved only 18 ANDAs.  This comes after October’s encouraging numbers, with OGD issuing 45 ANDA approvals.

If we take a walk down memory lane, back to the days of the generic drug scandal, approvals fell from 50-60 per month to a mere trickle of about 10 or less a month, until things started improving towards the end of FY 1991.

Right now, approval data is the only information relative to OGD productivity that is publically available as the Generic Drug Monthly Activity Report apparently fell victim to the new CDER IT platform (see previous story here).  The approval figures are obviously not representative of the total body of work that OGD produces as that includes (among other things) responses to controlled correspondence, Complete Response Letters, industry meetings, policy and procedure development, but it is certainly at the top of the list as the number one output product by which the generic industry gauges OGD success.

According to the Activity Report, the last approval for the month of November was issued on November 24, 2014.  The holiday and vacation over the Thanksgiving weekend routinely impacts the end of November, and we know that the end of December is also relatively slow for OGD approvals, but usually not so for submissions as firms race to the end of the year to get their applications into OGD.  But, this year, we may not even know what those submissions numbers look like until the IT folks in CDER can figure out how to generate the necessary reports that can be publically disseminated.  Unfortunately, this is another setback for the Generics program and we don’t even know how the new IT platform problem actually impacts OGD productivity or ability to track required data under GDUFA.

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